Immunosuppression in Solid Organ Transplant
Conditions
Brief summary
The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant
Interventions
DRUGTacrolimus
Capsules, Oral, dosed to achieve 12 hour trough level of 6-12 ng/mL, twice daily, 52 weeks (Short Term \[ST\]), in accordance with local practice and the package insert, 4 years (Long-Term Extension \[LTE\])
DRUGBasiliximab
Intravenous (IV), 20 mg, Day1 and Day 5
DRUGBelatacept More Intensive (MI)
Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension \[LTE\])
DRUGBelatacept Less Intensive (LI)
Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-Term Extension(LTE)
DRUGMycophenolate Mofetil (MMF)
Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term \[ST\]), ≤ 1 g/day, 4 years (Long-term extension \[LTE\])
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* First time recipient of deceased donor liver transplant * Age 18-70 * Hepatitis C virus (HCV) positive recipients * For Long-term extension study-Subjects who have completed one year of study treatment (through Week 52) Target Disease Exclusions: Donor Exclusions a) Living donors b) ABO-incompatible donor recipient pairs c) Donor age \< 12 or \> 65 years d) Non heart-beating donors e) Anticipated cold ischemia time \> 14 hours f) Donor Disease i) Known Human immunodeficiency virus (HIV) infection ii) Hepatitis B virus (HBV) surface antigen-positive or polymerase chain reaction (PCR)-positive donor if HBV negative recipient iii) HCV antibody-positive or PCR positive donor if HCV negative recipient Recipient Exclusions g) Subjects with a history of hypercoagulable state h) Subjects with fulminant hepatic failure i) Subjects receiving a split or reduced liver j) Subjects who are Epstein-Barr virus (EBV) negative Medical History and Concurrent Diseases 1. Subjects who have received 2 or more consecutive weeks of dialysis 1 month prior to enrollment OR anticipated to have prolonged dialysis post-transplantation 2. Subjects with known intrinsic renal disease (e.g., a urine protein/ creatinine ratio \> 150 mg/g or the presence of an abnormal number of red blood cells (RBCs) or granular casts in the urine) AND calculated GFR \< 40 ml/min/1.73 m\^2 body surface area (BSA) (abbreviated Modification of Diet in Renal Disease \[MDRD\]). Subjects must have a calculated GFR assessment within 1 month prior to enrollment. 3. Subjects with known HIV 4. Subjects with any prior or concurrent solid organ (e.g., heart, kidney, pancreas) or cell (e.g., islet, bone marrow) transplant or subjects deemed likely to have a second solid organ or cell transplant (e.g., islet, bone marrow) within the next 3 years. 5. Subjects with a history of cancer within the last 5 years Allergies and Adverse Drug Reactions a) Hypersensitivity to any medications that will be used in the protocol Prohibited Treatments and/or Therapies 1. Subjects receiving immunosuppressive agent(s) (e.g., methotrexate, abatacept, infliximab, etanercept, chemotherapy, etc.) within the past 6 months for other indications such as an autoimmune disease 2. Subjects who received maintenance corticosteroids at a dose of \> 5 mg/day of prednisone (or equivalent) for at least 7 consecutive days within the prior year for an underlying chronic inflammatory or autoimmune disease 3. Subjects who have used any investigational drug within 30 days prior to the Day 1 visit 4. Subjects previously treated with belatacept
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced at Least One Episode of Acute Rejection (AR), Graft Loss, or Death by 6 Months Post-transplant | At 6 months posttransplant | Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a blinded central histopathologist using Banff grading schema. Graft loss was defined as impairment of liver function to such a degree that the participant died or underwent re-transplantation. For 95% (confidence interval) CI within each group, normal approximation is used if N\>=5, otherwise exact method is used. |
| Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Day 1 (randomization) to Week 104 + within 56 Days after the last infusion/dose, Deaths were monitored up to database lock (20-June-2011) | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. |
| Number of Participants Who Had AEs of Special Interest During the LTE | Day 1 (randomization) through database lock (20-June-2011) | AE of special interest included malignancies (including skin carcinomas), infections (viral, cytomegalovirus, herpes, fungal, and bacterial). |
| Number of Participants With Marked Hematology Abnormalities During the LTE | Every 4 weeks from Week 53 to Week 104. | Low platelet count: \<50\*10\^9 c/µl; Low leukocytes: \<2.0\*10\^3 c/µl; Low lymphocytes (absolute): \<0.5\*10\^3 c/µl; Low neutrophils (absolute): \<1.0\*10\^3 c/µl. |
| Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | Every 4 weeks from Week 53 to Week 104. | ULN= upper limit of normal; Normal ranges are provided by the Central Laboratory and may vary according to sex and age. High alanine aminotransferase (ALT): \>5.0\*ULN U/L; High aspartate aminotransferase (AST): \>5.0\*ULN U/L; High direct bilirubin: \>3.0\*ULN mg/dL; High g-glutamyl transferase (GGT): \>5.0\*ULN U/L; High total bilirubin: \>3.0\*ULN mg/dL; High creatinine: \> 3.0\*ULN mg/dL |
| Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Every 4 weeks from Week 53 to Week 104. | Low Serum Potassium: \<3.0 meq/L; High serum potassium:\>6.0 mEq/L; Low serum magnesium:\<0.8 mEq/L; Low serum sodium: \<130 mEq/L; High serum sodium: \>155 mEq/L; Low inorganic phosphorus: \<2.0 mg/dL; High uric acid: \>10 mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | 3, 6 and 12 months posttransplant | Acute rejections were clinically suspected and biopsy proven by central pathologist. Corticosteroid-resistant rejection = Continued rejection, as documented by liver biopsy, after the completion of 2 days of corticosteroids and requiring use of T-cell depleting agent. Refractory rejection=Continued rejection, as documented by liver biopsy, after use of corticosteroids and T cell depletion therapy. Increase in the dose of TAC was monitored in participants who were assigned to one of the TAC-based regimens. TRT= treatment |
| Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | Day 1 (randomization) through database lock (20-June-2011) | Acute rejections were clinically suspected and biopsy proven by central pathologist. Corticosteroid-resistant rejection = Continued rejection, as documented by liver biopsy, after the completion of 2 days of corticosteroids and requiring use of T-cell depleting agent. Refractory rejection=Continued rejection, as documented by liver biopsy, after use of corticosteroids and T cell depletion therapy. Increase in the dose of TAC was monitored in participants who were assigned to one of the TAC-based regimens. DBL=database lock, TRT=treatment |
| Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | 3, 6 and 12 months posttransplant | Acute Rejections (AR) were clinically suspected and biopsy proven by central pathologist. The Banff grading is a classification of renal allograft pathology and AR. Grade I: AR requiring moderate (\>25%) to severe mononuclear cell interstitial infiltrate and moderate tubulitis; Grade II: AR requiring severe tubulitis and/or intimal arteritis; Grade III: AR requiring transmural arteritis. Only the episode with highest Banff grade for each participant was counted. |
| Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | 3, 6 and 12 months posttransplant | Acute Rejections were clinically suspected and biopsy proven by central pathologist. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI). An overall score of 0-2 is considered indeterminate, score of 3-4 is mild, score of 5-6 is moderate, and score of 7-9 is severe. Only the episode with the highest total RAI score for each participant was counted. |
| Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | Day 1 (randomization) through End of study (database lock of 20-June-2011) | Acute Rejections were clinically suspected and biopsy proven by central pathologist. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI). An overall score of 0-2 is considered indeterminate, score of 3-4 is mild, score of 5-6 is moderate, and score of 7-9 is severe. Only the episode with the highest total RAI score for each participant was counted. |
| Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | 3, 6, 9 and 12 months posttransplant | The time from transplantation to the first AR episode in each treatment arm was summarized using Kaplan-Meier curves. Acute Rejections were clinically suspected and biopsy proven by central pathologist. |
| Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | Baseline (2 month), 12 months posttransplant | GFR was assessed using a true measure of glomerular filtration via iothalamate clearance test. The month 2 time point was selected as the baseline time point with respect to measured GFR due to logistical difficulty in obtaining measured GFR at the time of liver transplant and post-transplant renal function largely stabilizing by 2 months. All Measured GFR \> 200 were truncated at 200. |
| Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Baseline [BL] (pretransplant time point), 1, 2, 3, 6 and 12 months posttransplant | GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine (ScR), age, race, gender, blood urea nitrogen (BUN), and albumin (Alb). GFR (mL/min/1.73 m\^2) = 170\*(Scr)\^-0.999\*(Age)\^-0.176\*(0.762 if female)\*(1.180 if African American)\*(BUN)\^-0.170\*(Alb)\^+0.318. ). BL= baseline, mL= milliliters; min= minute; m\^2= meters squared. |
| Mean Change From Baseline in Calculated GFR During the LTE | Baseline (pretransplant time point), 1, 2, 3, 6,12, 18, 24, 30, 36 months posttransplant | GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine (ScR), age, race, gender, blood urea nitrogen (BUN), and albumin (Alb). GFR (mL/min/1.73 m\^2) = 170\*(Scr)\^-0.999\*(Age)\^-0.176\*(0.762 if female)\*(1.180 if African American)\*(BUN)\^-0.170\*(Alb)\^+0.318. ). BL= baseline, mL= milliliters; min= minute; m\^2= meters squared. |
| Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Baseline (pretransplant time point), 1, 2, 3, 6 and 12 months posttransplant | Measurement of SCr is commonly used as an indicator of renal function. High creatinine blood level is an indicator of deficient filtering by the kidney. SCr was determined at baseline and various post-baseline time points. |
| Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Baseline (pretransplant), 2, and 12 months posttransplant | Cystatin C is a protein encoded by the CST3 gene, which is mainly used as a biomarker of kidney function. If kidney function and glomerular filtration rate decline, the blood levels of cystatin C rise. |
| Belatacept PK Parameter: Volume of Distribution | Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105. | Volume of distribution (Vss) is the volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration. . Vss was estimated from AUC (TAU) between Weeks 12 and 16, assuming steady state. |
| Belatacept Pharmacokinetic (PK) Parameter: Maximum Serum Concentration | Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105. | Maximum Plasma Concentration (Cmax) is the maximum observed serum drug concentration. |
| Belatacept Pharmacokinetic (PK) Parameter: Time to Achieve the Maximum Plasma Concentration | Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105. | Maximum Plasma Concentration (Tmax) is the time taken to reach the maximum observed plasma concentration. |
| Belatacept PK Parameter: Area Under the Serum Concentration-time Curve to the End of the Dosing Period (AUCtau) | Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105. | Area under the plasma concentration-time curve for each dosing interval is determined using the linear trapezoidal rule. The AUC(TAU) of belatacept from the MI regimens and LI regimens were calculated over 2 and 4 weeks respectively. |
| Belatacept PK Parameter: Minimum Plasma Concentration | Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105. | Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration. |
| Belatacept PK Parameter: Terminal Half-life | Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105. | Terminal Half-life (T 1/2) is the time a drug takes for the concentration levels to fall to 50% of their value. |
| Belatacept PK Parameter: Total Body Clearance | Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105. | Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism. CLT was estimated from AUC (TAU) between Weeks 12 and 16, assuming steady state. |
| Belatacept PK Parameter: Amount Excreted in Ascites Fluid Over Days 1 to 14 | Days 1 to 14 | Amount Excreted in Ascites (Ae,asc) was estimated from the ascites drug concentrations and volumes within a dosing interval. |
| Belatacept PK Parameter: Clearance From Ascites Fluid | Days 1 to 14 | Clearance from ascites fluid was determined by amount excreted in ascites fluid (Ae, asc)\[0-T\] / AUC\[0-T\], where 0-T is the same duration relative to a belatacept infusion. |
| Belatacept Trough Concentration Before Each Infusion During the LTE | Samples were collected predose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105, 532, 728. | Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration. |
| Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months | 6 and 12 months posttransplant | HCV Recurrence is defined as Histological confirmation on liver biopsy by the Ishak (modified Knodell) system and required both a score \>= 5 out of 18 on modified Histological Activity Index grading and a fibrosis Score \>= 2 out of 6 on modified staging. All biopsies, including Week 52 biopsies, were considered. Only the first HCV recurrence episode for each participant was counted. For 95% CI within each group, normal approximation was used if N\>=5, otherwise exact method was used. For 95% CI of difference, normal approximation was used if N\>=5 in both arms, otherwise exact method was used. |
| Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE | 12 months posttransplant, end of study (database lock, 20-June-2011) | HCV Recurrence is defined as Histological confirmation on liver biopsy by the Ishak (modified Knodell) system and required both a score \>= 5 out of 18 on modified Histological Activity Index grading and a fibrosis Score \>= 2 out of 6 on modified staging. All biopsies, including Week 52 biopsies, were considered. Only the first HCV recurrence episode for each participant was counted. For 95% CI within each group, normal approximation was used if N\>=5, otherwise exact method was used. For 95% CI of difference, normal approximation was used if N\>=5 in both arms, otherwise exact method was used. |
| Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | Baseline (pretransplant), 6 and 12 months (mo) posttransplant | Recurrent hepatitis C infection of the allograft following liver transplantation can be detected by monitoring HCV RNA levels. In HCV positive participants, quantitative HCV RNA levels \> 2.4 \* 10\^6 U/mL and \> 4.7 \* 10\^6 U/mL were descriptively summarized by treatment group. BL=baseline |
| Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | BL (pretransplant), 12, 18, 24, 30 months (mo) posttransplant | Recurrent hepatitis C infection of the allograft following liver transplantation can be detected by monitoring HCV RNA levels. In HCV positive participants, quantitative HCV RNA levels \> 2.4 x 10\^6 U/mL and \> 4.7 x 10\^6 U/mL were descriptively summarized by treatment group. BL = baseline |
| Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | 6 and 12 months posttransplant | Percentage of participants who develop dyslipidemia, defined as hypertriglyceridemia (triglycerides \[TGs\] ≥ 500 mg/dL \[5.65 mmol/L\]), hypercholesterolemia (Low density lipoprotein \[LDL\] ≥ 100 mg/dL \[2.59 mmol/L\]), or elevated non-high density lipoprotein (non- high density lipoprotein \[HDL\] ≥ 130 mg/dL \[3.36 mmol/L\]) in the presence of high TGs (TGs ≥ 200 mg/dL \[2.26 mmol/L\]). |
| Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 and 12 months posttransplant | Percentage of participants at any given time (at Month 6 and Month 12) who met the definition of dyslipidemia.Dyslipidemia is defined as hypertriglyceridemia (TGs ≥ 500 mg/dL \[5.65 mmol/L\]), hypercholesterolemia (LDL ≥ 100 mg/dL \[2.59 mmol/L\]), or elevated non-HDL (non-HDL ≥ 130 mg/dL \[3.36 mmol/L\]) in the presence of high TGs (TGs ≥ 200 mg/dL \[2.26 mmol/L\]). |
| Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Baseline (pretransplant), 1, 6, 12 months posttransplant | — |
| Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Baseline (pretransplant), 1, 6, 12 months posttransplant | — |
| Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Baseline (pretransplant), 1, 6, 12 months posttransplant | — |
| Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Baseline (pretransplant), 1, 6, 12 months posttransplant | — |
| Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Baseline (pretransplant), 1, 6, 12 months posttransplant | — |
| Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Baseline (pretransplant), 1, 3, 6, 9, 12 months posttransplant | — |
| Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | BL (pretransplant), 1, 3, 6, 9, 12 months posttransplant | Participants were considered to have hypertension if they had Diastolic Blood Pressure (SBP) ≥ 80 mmHg. |
| Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | BL (pretransplant), 1, 3, 6, 9, 12 months posttransplant | — |
| Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase | 6 and 12 months posttransplant | Percentage of participants who develop hypertension after randomization and transplantation. Transient post-operative increases in BP were not to be counted as new onset hypertension. Hypertension was to be assessed only at or after the Week 4 visit. Participants were considered to have hypertension when either of the following criteria were met: (1) SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg or (2) participant received an antihypertensive medication(s) for the indication of hypertension or due to medical history of hypertension. |
| Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase | 6 and 12 months posttransplant | Percentage of participants at any given time who meet the definition of hypertension. Participants were considered to have hypertension when either of the following criteria were met: (1) SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg or (2) participant received an antihypertensive medication(s) for the indication of hypertension or due to medical history of hypertension. |
| Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | 12 months posttransplant | — |
| Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase | 6 and 12 months posttransplant | A participant who did not have diabetes prior to randomization was determined to have NODM if(i) the participant received an antidiabetic medication for a duration of at least 30 days or(ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is\>=126 mg/dL (7.0 mmol/L). For 95% CI within each group, normal approximation is used if N\>=5. For 95% CI of difference, adjustment is made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. |
| Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6, 12 months (mth) posttransplant | The HbA1c test is important in diabetes as a long-term measure of control over blood glucose, where the glucose bound to hemoglobin during the past 3-4 months is measured. A baseline diabetes participant was one who had a medical history of diabetes or being under anti-diabetic medication at the time of the transplantation. BL = baseline, DM = Diabetes mellitus. |
| Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Day 1 (randomization) to 12 m + 8 week follow-up or ≤ 56 days after discontinuation of study medication | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event |
| Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Day 1 (randomization) to 12 months or ≤ 56 days after discontinuation of study medication | AE of of special interest included malignancies (including skin carcinomas), infections (viral, cytomegalovirus, herpes, fungal, and bacterial), serious infections |
| Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Baseline (pretransplant), 2, 4, 8, 12 weeks, and every 4 weeks for week 16 to 52 | Low hemoglobin: \<8 g/dL; Low platelet count: \<50\*10\^9 C/L; Low leukocytes: \<2.0 \*10\^3 c/µL; Low lymphocytes (absolute): \<0.5\*10\^3 c/µL; Low neutrophils (absolute): \<1.0\*10\^3 Cc/µL. |
| Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | Baseline (pretransplant), 4, 12, 24, 52 weeks | ULN= upper limit of normal; Normal ranges are provided by the central laboratory and may vary according to sex and age. High alkaline phosphatase (ALP): \>5.0\*ULN U/L; High alanine aminotransferase (ALT): \>5.0\*ULN U/L; High aspartate aminotransferase (AST): \>5.0\*ULN U/L; High direct bilirubin: \>3.0 \* ULN mg/dL; High g-glutamyl transferase (GGT): \>5.0\*ULN U/L; High total bilirubin: \>3.0\*ULN mg/dL; High creatinine: \> 3.0\*ULN mg/dL |
| Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Baseline (pretransplant), Weeks 4, 12, 24, and 52 | Low total calcium: \<7 mg/dL; High total calcium: \>12.5 mg/dL ; Low bicarbonate: \<11 mEq/L; Low serum potassium: \<3.0 mEq/L; High serum potassium:\>6.0 mEq/L; High serum magnesium: \>2.46 mEq/L; Low serum magnesium:\<0.8 mEq/L; Low serum sodium: \<130 mEq/L; High serum sodium: \>155 mEq/L; Low inorganic phosphorus: \<2.0 mg/dL; Low albumin: \<2 g/dL; High uric acid: \>10 mg/dL |
| Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase | At 6 and 12 months | For 95% CI within each group, normal approximation was used if N\>=5. Otherwise exact method was used. |
| Change in Protein to Creatinine Ratio From Month 3 to Month 12. | Month 3 and 12 | — |
| Number of Participants Who Had Abnormalities in Electrocardiograms: 12-month Treatment Phase | Baseline (pretransplant), Week 52 | — |
| Percentage of Participants Surviving With Functional Graft by End of Study (Includes LTE Data) | Day 1 (randomization) through database lock (20-June-2011) | For 95% CI within each group, normal approximation was used if N\>=5, otherwise exact method was used. |
| Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by 12 Months | At 12 months posttransplant | Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a blinded central histopathologist using Banff grading. Graft loss was defined as impairment of liver function to such a degree that the participant died or underwent re-transplantation. For 95% CI within each group, normal approximation is used if N\>=5. Otherwise exact method is used. For 95% CI of difference, adjustment is made for randomization strata if N \>= 5 in each treatment arm. |
| Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by End of Study (Includes LTE Data) | Day 1 (randomization) through database lock (20-June-2011) | Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a central histopathologist using Banff criteria. For 95% CI within each group, normal approximation was used if N\>=5, otherwise exact method was used. |
| Number of Participants Having Acute Rejections: 12-month Treatment Phase | 3 , 6, and 12 months | Acute rejections were clinically suspected and biopsy proven by central pathologist. The number of episodes of AR was counted. |
| Number of Participants Having Acute Rejections During the LTE | Day 1 (randomization) through database lock (20-June-2011) | Acute rejections were clinically suspected and biopsy proven by central pathologist. The number of episodes of AR was counted. |
Countries
Argentina, Austria, Brazil, Canada, France, Germany, Italy, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension \[LTE\]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE) | 50 |
| Group 2: Belatacept (MI) + MMF Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE) | 48 |
| Group 3: Belatacept (LI) + MMF Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST\]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE) | 49 |
| Group 4: Tacrolimus + MMF Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE) | 53 |
| Group 5: Tacrolimus Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE) | 50 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Long-term Extension Phase | Administrative reason by sponsor | 23 | 21 | 18 | 31 | 23 |
| Long-term Extension Phase | Adverse Event | 2 | 5 | 2 | 1 | 0 |
| Long-term Extension Phase | Death | 2 | 0 | 0 | 3 | 0 |
| Long-term Extension Phase | Other Reason | 1 | 0 | 2 | 0 | 0 |
| Long-term Extension Phase | Participant did not meet study criteria | 0 | 0 | 0 | 0 | 1 |
| Long-term Extension Phase | Withdrawal by Subject | 2 | 1 | 2 | 3 | 2 |
| Treatment Phase up to 12-months | Adverse Event | 6 | 7 | 11 | 7 | 18 |
| Treatment Phase up to 12-months | Death | 2 | 1 | 4 | 0 | 0 |
| Treatment Phase up to 12-months | Lack of Efficacy | 9 | 8 | 5 | 0 | 0 |
| Treatment Phase up to 12-months | Never treated | 2 | 3 | 1 | 0 | 4 |
| Treatment Phase up to 12-months | Other Reason | 1 | 3 | 2 | 0 | 0 |
| Treatment Phase up to 12-months | Withdrawal by Subject | 1 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 1: Basiliximab+Belatacept (MI) + MMF | Total | Group 5: Tacrolimus | Group 4: Tacrolimus + MMF | Group 3: Belatacept (LI) + MMF | Group 2: Belatacept (MI) + MMF |
|---|---|---|---|---|---|---|
| Age, Customized 18 to 45 years | 7 participants | 33 participants | 4 participants | 11 participants | 4 participants | 7 participants |
| Age, Customized 46 to 65 years | 41 participants | 203 participants | 42 participants | 37 participants | 43 participants | 40 participants |
| Age, Customized Above 65 years | 2 participants | 14 participants | 4 participants | 5 participants | 2 participants | 1 participants |
| Model for End-Stage Liver Disease (MELD) score | 22.0 units on a scale FULL_RANGE 8.19 | 22.0 units on a scale | 22.0 units on a scale FULL_RANGE 5.48 | 24.0 units on a scale FULL_RANGE 7.48 | 22.0 units on a scale FULL_RANGE 6.05 | 22.0 units on a scale FULL_RANGE 8.29 |
| Participants on Anti-diabetic Medications No | 35 participants | 189 participants | 38 participants | 41 participants | 40 participants | 35 participants |
| Participants on Anti-diabetic Medications Yes | 15 participants | 61 participants | 12 participants | 12 participants | 9 participants | 13 participants |
| Participants on Anti-Hypertensive Medications No | 41 participants | 203 participants | 40 participants | 42 participants | 41 participants | 39 participants |
| Participants on Anti-Hypertensive Medications Yes | 9 participants | 47 participants | 10 participants | 11 participants | 8 participants | 9 participants |
| Participants on Lipid Lowering Medications No | 46 participants | 232 participants | 44 participants | 51 participants | 48 participants | 43 participants |
| Participants on Lipid Lowering Medications Yes | 4 participants | 18 participants | 6 participants | 2 participants | 1 participants | 5 participants |
| Primary cause of End Stage Liver Disease (ESLD) Acute hepatic necrosis | 4 participants | 8 participants | 0 participants | 1 participants | 3 participants | 0 participants |
| Primary cause of End Stage Liver Disease (ESLD) Biliary atresia | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants |
| Primary cause of End Stage Liver Disease (ESLD) Cholestatic liver disease cirrhosis | 0 participants | 9 participants | 2 participants | 1 participants | 3 participants | 3 participants |
| Primary cause of End Stage Liver Disease (ESLD) Malignant neoplasms | 4 participants | 25 participants | 3 participants | 6 participants | 5 participants | 7 participants |
| Primary cause of End Stage Liver Disease (ESLD) Metabolic disease | 0 participants | 3 participants | 0 participants | 1 participants | 0 participants | 2 participants |
| Primary cause of End Stage Liver Disease (ESLD) Non-cholestatic cirrhosis | 38 participants | 184 participants | 41 participants | 39 participants | 33 participants | 33 participants |
| Primary cause of End Stage Liver Disease (ESLD) Other | 4 participants | 20 participants | 4 participants | 4 participants | 5 participants | 3 participants |
| Race/Ethnicity, Customized American Indian / Alaska native | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 3 participants | 0 participants | 0 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Black / African American | 4 participants | 13 participants | 2 participants | 3 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Hispanic or Latino (US sites) | 5 participants | 22 participants | 4 participants | 3 participants | 3 participants | 7 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino (US sites) | 28 participants | 100 participants | 23 participants | 22 participants | 11 participants | 16 participants |
| Race/Ethnicity, Customized Other | 1 participants | 11 participants | 5 participants | 1 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized Unknown (Non- US sites) | 17 participants | 128 participants | 23 participants | 28 participants | 35 participants | 25 participants |
| Race/Ethnicity, Customized White | 44 participants | 222 participants | 43 participants | 49 participants | 46 participants | 40 participants |
| Sex: Female, Male Female | 11 Participants | 58 Participants | 8 Participants | 7 Participants | 18 Participants | 14 Participants |
| Sex: Female, Male Male | 39 Participants | 192 Participants | 42 Participants | 46 Participants | 31 Participants | 34 Participants |
| United Network for Organ Sharing (UNOS) Status Not available | 44 participants | 221 participants | 47 participants | 48 participants | 40 participants | 42 participants |
| United Network for Organ Sharing (UNOS) Status Status 1 | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| United Network for Organ Sharing (UNOS) Status Status 2A | 1 participants | 7 participants | 0 participants | 3 participants | 2 participants | 1 participants |
| United Network for Organ Sharing (UNOS) Status Status 2B | 3 participants | 13 participants | 2 participants | 1 participants | 5 participants | 2 participants |
| United Network for Organ Sharing (UNOS) Status Status 3 | 2 participants | 8 participants | 1 participants | 1 participants | 2 participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 29 / 30 | 23 / 24 | 27 / 27 | 25 / 26 | 38 / 38 |
| serious Total, serious adverse events | 18 / 30 | 17 / 24 | 22 / 27 | 21 / 26 | 29 / 38 |
Outcome results
Primary
Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data)
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Time frame: Day 1 (randomization) to Week 104 + within 56 Days after the last infusion/dose, Deaths were monitored up to database lock (20-June-2011)
Population: ITT-LTE population, (all randomized and transplanted participants who entered long term extension). Participants were grouped according to the treatment to which they were randomized initially.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Deaths (due to AE) | 2 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Discontinued due to SAEs | 2 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | SAEs | 18 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Discontinued due to AEs | 2 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Related AEs | 27 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | AEs | 30 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Deaths (not due to AE) | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Related SAEs | 5 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Related AEs | 21 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Discontinued due to AEs | 5 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Related SAEs | 9 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Deaths (not due to AE) | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Discontinued due to SAEs | 4 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | SAEs | 22 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | AEs | 27 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Deaths (due to AE) | 3 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Deaths (due to AE) | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Discontinued due to AEs | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Deaths (not due to AE) | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | AEs | 23 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Related SAEs | 9 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | SAEs | 17 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Discontinued due to SAEs | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Related AEs | 20 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Discontinued due to AEs | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | SAEs | 29 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Related SAEs | 12 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Discontinued due to SAEs | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | AEs | 38 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Related AEs | 33 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Deaths (due to AE) | 3 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Deaths (not due to AE) | 0 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | AEs | 26 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Deaths (not due to AE) | 0 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Deaths (due to AE) | 0 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Discontinued due to SAEs | 0 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Related SAEs | 9 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | SAEs | 21 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Discontinued due to AEs | 0 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) | Related AEs | 23 participants |
Primary
Number of Participants Who Had AEs of Special Interest During the LTE
AE of special interest included malignancies (including skin carcinomas), infections (viral, cytomegalovirus, herpes, fungal, and bacterial).
Time frame: Day 1 (randomization) through database lock (20-June-2011)
Population: ITT-LTE population, all randomized and transplanted participants who entered long term extension
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had AEs of Special Interest During the LTE | Infections and Infestations | 8 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had AEs of Special Interest During the LTE | Malignancies | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had AEs of Special Interest During the LTE | Malignancies | 4 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had AEs of Special Interest During the LTE | Infections and Infestations | 6 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had AEs of Special Interest During the LTE | Infections and Infestations | 9 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had AEs of Special Interest During the LTE | Malignancies | 3 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had AEs of Special Interest During the LTE | Malignancies | 8 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had AEs of Special Interest During the LTE | Infections and Infestations | 11 participants |
| Group 5: Tacrolimus | Number of Participants Who Had AEs of Special Interest During the LTE | Malignancies | 3 participants |
| Group 5: Tacrolimus | Number of Participants Who Had AEs of Special Interest During the LTE | Infections and Infestations | 8 participants |
Primary
Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE
Low Serum Potassium: \<3.0 meq/L; High serum potassium:\>6.0 mEq/L; Low serum magnesium:\<0.8 mEq/L; Low serum sodium: \<130 mEq/L; High serum sodium: \>155 mEq/L; Low inorganic phosphorus: \<2.0 mg/dL; High uric acid: \>10 mg/dL
Time frame: Every 4 weeks from Week 53 to Week 104.
Population: ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Serum Potassium | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Serum Potassium | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Serum Sodium | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Serum Sodium | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Inorganic Phosphorus | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Uric Acid | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Inorganic Phosphorus | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Uric Acid | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Serum Potassium | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Serum Sodium | 2 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Serum Sodium | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Serum Potassium | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Serum Sodium | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Inorganic Phosphorus | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Serum Potassium | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Serum Sodium | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Serum Potassium | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Uric Acid | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Serum Sodium | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Serum Potassium | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Serum Sodium | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Uric Acid | 6 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Inorganic Phosphorus | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Serum Potassium | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Inorganic Phosphorus | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Serum Sodium | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Serum Potassium | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Uric Acid | 6 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | High Serum Sodium | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE | Low Serum Potassium | 0 participants |
Primary
Number of Participants With Marked Hematology Abnormalities During the LTE
Low platelet count: \<50\*10\^9 c/µl; Low leukocytes: \<2.0\*10\^3 c/µl; Low lymphocytes (absolute): \<0.5\*10\^3 c/µl; Low neutrophils (absolute): \<1.0\*10\^3 c/µl.
Time frame: Every 4 weeks from Week 53 to Week 104.
Population: ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Absolute Lymphocyte: (n=29, 27, 22, 36, 25) | 8 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Platelets: (n=29, 26, 22, 37, 25) | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Leukocytes : (n=29, 27, 22, 37, 25) | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Absolute Neutrophils: (n=29, 27, 22, 36, 25) | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Leukocytes : (n=29, 27, 22, 37, 25) | 2 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Platelets: (n=29, 26, 22, 37, 25) | 2 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Absolute Lymphocyte: (n=29, 27, 22, 36, 25) | 3 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Absolute Neutrophils: (n=29, 27, 22, 36, 25) | 2 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Platelets: (n=29, 26, 22, 37, 25) | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Absolute Neutrophils: (n=29, 27, 22, 36, 25) | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Leukocytes : (n=29, 27, 22, 37, 25) | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Absolute Lymphocyte: (n=29, 27, 22, 36, 25) | 3 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Platelets: (n=29, 26, 22, 37, 25) | 2 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Absolute Neutrophils: (n=29, 27, 22, 36, 25) | 2 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Absolute Lymphocyte: (n=29, 27, 22, 36, 25) | 5 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Leukocytes : (n=29, 27, 22, 37, 25) | 3 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Leukocytes : (n=29, 27, 22, 37, 25) | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Platelets: (n=29, 26, 22, 37, 25) | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Absolute Neutrophils: (n=29, 27, 22, 36, 25) | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Hematology Abnormalities During the LTE | Low Absolute Lymphocyte: (n=29, 27, 22, 36, 25) | 3 participants |
Primary
Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE
ULN= upper limit of normal; Normal ranges are provided by the Central Laboratory and may vary according to sex and age. High alanine aminotransferase (ALT): \>5.0\*ULN U/L; High aspartate aminotransferase (AST): \>5.0\*ULN U/L; High direct bilirubin: \>3.0\*ULN mg/dL; High g-glutamyl transferase (GGT): \>5.0\*ULN U/L; High total bilirubin: \>3.0\*ULN mg/dL; High creatinine: \> 3.0\*ULN mg/dL
Time frame: Every 4 weeks from Week 53 to Week 104.
Population: ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High ALT | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High AST | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Direct Bilirubin | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High GGT | 2 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Total Bilirubin | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Creatinine | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Total Bilirubin | 3 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Creatinine | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High ALT | 2 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Direct Bilirubin | 4 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High GGT | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High AST | 3 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High GGT | 6 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Total Bilirubin | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High ALT | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Direct Bilirubin | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High AST | 2 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Creatinine | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High GGT | 13 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High AST | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Direct Bilirubin | 3 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Creatinine | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Total Bilirubin | 2 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High ALT | 4 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Total Bilirubin | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Direct Bilirubin | 2 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High AST | 3 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High Creatinine | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High GGT | 8 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE | High ALT | 3 participants |
Primary
Percentage of Participants Who Experienced at Least One Episode of Acute Rejection (AR), Graft Loss, or Death by 6 Months Post-transplant
Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a blinded central histopathologist using Banff grading schema. Graft loss was defined as impairment of liver function to such a degree that the participant died or underwent re-transplantation. For 95% (confidence interval) CI within each group, normal approximation is used if N\>=5, otherwise exact method is used.
Time frame: At 6 months posttransplant
Population: Intent-to-Treat (ITT) population: all randomized and transplanted participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection (AR), Graft Loss, or Death by 6 Months Post-transplant | 48.0 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection (AR), Graft Loss, or Death by 6 Months Post-transplant | 41.7 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection (AR), Graft Loss, or Death by 6 Months Post-transplant | 46.9 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection (AR), Graft Loss, or Death by 6 Months Post-transplant | 15.1 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection (AR), Graft Loss, or Death by 6 Months Post-transplant | 38.0 percentage of participants |
95% CI: [16.1, 49.8]
95% CI: [9.6, 43.5]
95% CI: [14.8, 48.5]
95% CI: [-8.7, 29.6]
95% CI: [-15.3, 23.2]
95% CI: [-9.8, 28.4]
Secondary
Belatacept Pharmacokinetic (PK) Parameter: Maximum Serum Concentration
Maximum Plasma Concentration (Cmax) is the maximum observed serum drug concentration.
Time frame: Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.
Population: All randomized participants who received belatacept, and had complete PK profile.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept Pharmacokinetic (PK) Parameter: Maximum Serum Concentration | 221.3 µg/mL | Geometric Coefficient of Variation 29 |
| Group 2: Belatacept (MI) + MMF | Belatacept Pharmacokinetic (PK) Parameter: Maximum Serum Concentration | 227.6 µg/mL | Geometric Coefficient of Variation 23 |
| Group 3: Belatacept (LI) + MMF | Belatacept Pharmacokinetic (PK) Parameter: Maximum Serum Concentration | 205.4 µg/mL | Geometric Coefficient of Variation 20 |
Secondary
Belatacept Pharmacokinetic (PK) Parameter: Time to Achieve the Maximum Plasma Concentration
Maximum Plasma Concentration (Tmax) is the time taken to reach the maximum observed plasma concentration.
Time frame: Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.
Population: All randomized participants who received belatacept, and had complete PK profile.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept Pharmacokinetic (PK) Parameter: Time to Achieve the Maximum Plasma Concentration | 1.00 hour |
| Group 2: Belatacept (MI) + MMF | Belatacept Pharmacokinetic (PK) Parameter: Time to Achieve the Maximum Plasma Concentration | 1.08 hour |
| Group 3: Belatacept (LI) + MMF | Belatacept Pharmacokinetic (PK) Parameter: Time to Achieve the Maximum Plasma Concentration | 1.00 hour |
Secondary
Belatacept PK Parameter: Amount Excreted in Ascites Fluid Over Days 1 to 14
Amount Excreted in Ascites (Ae,asc) was estimated from the ascites drug concentrations and volumes within a dosing interval.
Time frame: Days 1 to 14
Population: All randomized participants who received belatacept, and had complete PK profile.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept PK Parameter: Amount Excreted in Ascites Fluid Over Days 1 to 14 | 46654 µg | Standard Deviation 59210 |
| Group 2: Belatacept (MI) + MMF | Belatacept PK Parameter: Amount Excreted in Ascites Fluid Over Days 1 to 14 | 31425 µg | Standard Deviation 40382 |
| Group 3: Belatacept (LI) + MMF | Belatacept PK Parameter: Amount Excreted in Ascites Fluid Over Days 1 to 14 | 81451 µg | Standard Deviation 95931 |
Secondary
Belatacept PK Parameter: Area Under the Serum Concentration-time Curve to the End of the Dosing Period (AUCtau)
Area under the plasma concentration-time curve for each dosing interval is determined using the linear trapezoidal rule. The AUC(TAU) of belatacept from the MI regimens and LI regimens were calculated over 2 and 4 weeks respectively.
Time frame: Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.
Population: All randomized participants who received belatacept, and had complete PK profile.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept PK Parameter: Area Under the Serum Concentration-time Curve to the End of the Dosing Period (AUCtau) | 19865 µg*h/mL | Geometric Coefficient of Variation 21 |
| Group 2: Belatacept (MI) + MMF | Belatacept PK Parameter: Area Under the Serum Concentration-time Curve to the End of the Dosing Period (AUCtau) | 21526 µg*h/mL | Geometric Coefficient of Variation 44 |
| Group 3: Belatacept (LI) + MMF | Belatacept PK Parameter: Area Under the Serum Concentration-time Curve to the End of the Dosing Period (AUCtau) | 19730 µg*h/mL | Geometric Coefficient of Variation 22 |
Secondary
Belatacept PK Parameter: Clearance From Ascites Fluid
Clearance from ascites fluid was determined by amount excreted in ascites fluid (Ae, asc)\[0-T\] / AUC\[0-T\], where 0-T is the same duration relative to a belatacept infusion.
Time frame: Days 1 to 14
Population: Serum AUC was not available for the time interval corresponding to ascites fluid collection.
Secondary
Belatacept PK Parameter: Minimum Plasma Concentration
Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration.
Time frame: Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.
Population: All randomized participants who received belatacept, and had complete PK profile.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept PK Parameter: Minimum Plasma Concentration | 23.63 µg/mL | Geometric Coefficient of Variation 30 |
| Group 2: Belatacept (MI) + MMF | Belatacept PK Parameter: Minimum Plasma Concentration | 27.20 µg/mL | Geometric Coefficient of Variation 37 |
| Group 3: Belatacept (LI) + MMF | Belatacept PK Parameter: Minimum Plasma Concentration | 5.91 µg/mL | Geometric Coefficient of Variation 50 |
Secondary
Belatacept PK Parameter: Terminal Half-life
Terminal Half-life (T 1/2) is the time a drug takes for the concentration levels to fall to 50% of their value.
Time frame: Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.
Population: All randomized participants who received belatacept, and had complete PK profile.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept PK Parameter: Terminal Half-life | 240.80 hour | Standard Deviation 47.82 |
| Group 2: Belatacept (MI) + MMF | Belatacept PK Parameter: Terminal Half-life | 227.74 hour | Standard Deviation 56.15 |
| Group 3: Belatacept (LI) + MMF | Belatacept PK Parameter: Terminal Half-life | 207.88 hour | Standard Deviation 31.66 |
Secondary
Belatacept PK Parameter: Total Body Clearance
Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism. CLT was estimated from AUC (TAU) between Weeks 12 and 16, assuming steady state.
Time frame: Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.
Population: All randomized participants who received belatacept, and had complete PK profile.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept PK Parameter: Total Body Clearance | 0.45 mL/h/kg | Geometric Coefficient of Variation 28 |
| Group 2: Belatacept (MI) + MMF | Belatacept PK Parameter: Total Body Clearance | 0.41 mL/h/kg | Geometric Coefficient of Variation 46 |
| Group 3: Belatacept (LI) + MMF | Belatacept PK Parameter: Total Body Clearance | 0.45 mL/h/kg | Geometric Coefficient of Variation 22 |
Secondary
Belatacept PK Parameter: Volume of Distribution
Volume of distribution (Vss) is the volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration. . Vss was estimated from AUC (TAU) between Weeks 12 and 16, assuming steady state.
Time frame: Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.
Population: All randomized participants who received belatacept, and had complete PK profile.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept PK Parameter: Volume of Distribution | 0.09 L/kg | Standard Deviation 0.02 |
| Group 2: Belatacept (MI) + MMF | Belatacept PK Parameter: Volume of Distribution | 0.08 L/kg | Standard Deviation 0.04 |
| Group 3: Belatacept (LI) + MMF | Belatacept PK Parameter: Volume of Distribution | 0.11 L/kg | Standard Deviation 0.03 |
Secondary
Belatacept Trough Concentration Before Each Infusion During the LTE
Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration.
Time frame: Samples were collected predose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105, 532, 728.
Population: All randomized participants who received Belatacept, and had complete PK profile. n= participants with values at all time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 728: (n=10, 12, 14) | 4.75 µg/mL | Geometric Coefficient of Variation 53.56 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 168: (n=30, 29, 29) | 7.30 µg/mL | Geometric Coefficient of Variation 58.14 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 252: (n=28, 28, 27) | 3.65 µg/mL | Geometric Coefficient of Variation 67.07 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 336: (n=26, 23, 21) | 3.22 µg/mL | Geometric Coefficient of Variation 70.42 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 364: (n=28, 28, 22 ) | 2.52 µg/mL | Geometric Coefficient of Variation 70.82 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 532: (n=22, 24, 14) | 2.71 µg/mL | Geometric Coefficient of Variation 55.53 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 5: (n=40, 43, 41) | 79.15 µg/mL | Geometric Coefficient of Variation 33.32 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 14: (n=41, 43, 38) | 32.39 µg/mL | Geometric Coefficient of Variation 40.85 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 28: (n=42, 38, 37) | 23.51 µg/mL | Geometric Coefficient of Variation 46.71 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 56: (n=12, 13, 12) | 18.91 µg/mL | Geometric Coefficient of Variation 39.74 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 84: (n=34, 31, 34 ) | 27.11 µg/mL | Geometric Coefficient of Variation 38.29 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 112: (n=29, 26, 29) | 10.12 µg/mL | Geometric Coefficient of Variation 63.71 |
| Group 2: Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 14: (n=41, 43, 38) | 31.16 µg/mL | Geometric Coefficient of Variation 39.74 |
| Group 2: Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 112: (n=29, 26, 29) | 9.64 µg/mL | Geometric Coefficient of Variation 59.28 |
| Group 2: Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 728: (n=10, 12, 14) | 4.20 µg/mL | Geometric Coefficient of Variation 59.28 |
| Group 2: Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 84: (n=34, 31, 34 ) | 27.32 µg/mL | Geometric Coefficient of Variation 56.13 |
| Group 2: Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 168: (n=30, 29, 29) | 8.01 µg/mL | Geometric Coefficient of Variation 64.97 |
| Group 2: Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 56: (n=12, 13, 12) | 18.84 µg/mL | Geometric Coefficient of Variation 36.85 |
| Group 2: Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 5: (n=40, 43, 41) | 79.40 µg/mL | Geometric Coefficient of Variation 33.19 |
| Group 2: Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 252: (n=28, 28, 27) | 3.74 µg/mL | Geometric Coefficient of Variation 65.78 |
| Group 2: Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 532: (n=22, 24, 14) | 4.68 µg/mL | Geometric Coefficient of Variation 57.61 |
| Group 2: Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 28: (n=42, 38, 37) | 22.23 µg/mL | Geometric Coefficient of Variation 47.49 |
| Group 2: Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 336: (n=26, 23, 21) | 3.38 µg/mL | Geometric Coefficient of Variation 62.1 |
| Group 2: Belatacept (MI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 364: (n=28, 28, 22 ) | 4.01 µg/mL | Geometric Coefficient of Variation 55.68 |
| Group 3: Belatacept (LI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 336: (n=26, 23, 21) | 4.37 µg/mL | Geometric Coefficient of Variation 29.72 |
| Group 3: Belatacept (LI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 364: (n=28, 28, 22 ) | 3.62 µg/mL | Geometric Coefficient of Variation 48.17 |
| Group 3: Belatacept (LI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 532: (n=22, 24, 14) | 4.91 µg/mL | Geometric Coefficient of Variation 34.49 |
| Group 3: Belatacept (LI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 728: (n=10, 12, 14) | 4.22 µg/mL | Geometric Coefficient of Variation 46.73 |
| Group 3: Belatacept (LI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 5: (n=40, 43, 41) | 70.88 µg/mL | Geometric Coefficient of Variation 38.66 |
| Group 3: Belatacept (LI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 56: (n=12, 13, 12) | 6.57 µg/mL | Geometric Coefficient of Variation 82.41 |
| Group 3: Belatacept (LI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 112: (n=29, 26, 29) | 6.75 µg/mL | Geometric Coefficient of Variation 64.11 |
| Group 3: Belatacept (LI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 14: (n=41, 43, 38) | 29.21 µg/mL | Geometric Coefficient of Variation 47.62 |
| Group 3: Belatacept (LI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 168: (n=30, 29, 29) | 3.57 µg/mL | Geometric Coefficient of Variation 52.56 |
| Group 3: Belatacept (LI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 84: (n=34, 31, 34 ) | 6.60 µg/mL | Geometric Coefficient of Variation 54.25 |
| Group 3: Belatacept (LI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 252: (n=28, 28, 27) | 3.59 µg/mL | Geometric Coefficient of Variation 50.93 |
| Group 3: Belatacept (LI) + MMF | Belatacept Trough Concentration Before Each Infusion During the LTE | Day 28: (n=42, 38, 37) | 21.72 µg/mL | Geometric Coefficient of Variation 47.64 |
Secondary
Change in Protein to Creatinine Ratio From Month 3 to Month 12.
Time frame: Month 3 and 12
Population: Protein creatinine ratio change was not analyzed
Secondary
Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase
The HbA1c test is important in diabetes as a long-term measure of control over blood glucose, where the glucose bound to hemoglobin during the past 3-4 months is measured. A baseline diabetes participant was one who had a medical history of diabetes or being under anti-diabetic medication at the time of the transplantation. BL = baseline, DM = Diabetes mellitus.
Time frame: 6, 12 months (mth) posttransplant
Population: ITT population, all randomized and transplanted participants. n = Participants with both baseline and postbaseline values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: All participants (n=39, 34, 38, 47, 35) | 5.8 Percentage of glycosylated hemoglobin | Standard Deviation 1.07 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: DM at BL/DM at 12 mth (n=23,13 ,11,18,20) | 6.3 Percentage of glycosylated hemoglobin | Standard Deviation 1.58 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: All participants (n=40, 35, 35, 44, 37) | 6.0 Percentage of glycosylated hemoglobin | Standard Deviation 1.32 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: DM at BL (n=15, 11, 7, 11, 12) | 6.9 Percentage of glycosylated hemoglobin | Standard Deviation 1.6 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: DM at BL (n=15, 12, 10, 12, 10) | 6.5 Percentage of glycosylated hemoglobin | Standard Deviation 1.19 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: DM at BL/DM at 6m (n=23, 14, 14, 19, 18) | 6.1 Percentage of glycosylated hemoglobin | Standard Deviation 1.17 |
| Group 2: Belatacept (MI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: DM at BL (n=15, 11, 7, 11, 12) | 6.7 Percentage of glycosylated hemoglobin | Standard Deviation 1.4 |
| Group 2: Belatacept (MI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: DM at BL/DM at 12 mth (n=23,13 ,11,18,20) | 6.6 Percentage of glycosylated hemoglobin | Standard Deviation 1.29 |
| Group 2: Belatacept (MI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: DM at BL/DM at 6m (n=23, 14, 14, 19, 18) | 6.4 Percentage of glycosylated hemoglobin | Standard Deviation 1.02 |
| Group 2: Belatacept (MI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: All participants (n=39, 34, 38, 47, 35) | 5.8 Percentage of glycosylated hemoglobin | Standard Deviation 0.96 |
| Group 2: Belatacept (MI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: DM at BL (n=15, 12, 10, 12, 10) | 6.6 Percentage of glycosylated hemoglobin | Standard Deviation 1.02 |
| Group 2: Belatacept (MI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: All participants (n=40, 35, 35, 44, 37) | 5.8 Percentage of glycosylated hemoglobin | Standard Deviation 1.03 |
| Group 3: Belatacept (LI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: DM at BL (n=15, 12, 10, 12, 10) | 6.1 Percentage of glycosylated hemoglobin | Standard Deviation 0.76 |
| Group 3: Belatacept (LI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: All participants (n=39, 34, 38, 47, 35) | 5.6 Percentage of glycosylated hemoglobin | Standard Deviation 0.75 |
| Group 3: Belatacept (LI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: DM at BL (n=15, 11, 7, 11, 12) | 6.7 Percentage of glycosylated hemoglobin | Standard Deviation 1.49 |
| Group 3: Belatacept (LI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: All participants (n=40, 35, 35, 44, 37) | 5.7 Percentage of glycosylated hemoglobin | Standard Deviation 0.97 |
| Group 3: Belatacept (LI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: DM at BL/DM at 6m (n=23, 14, 14, 19, 18) | 5.9 Percentage of glycosylated hemoglobin | Standard Deviation 0.9 |
| Group 3: Belatacept (LI) + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: DM at BL/DM at 12 mth (n=23,13 ,11,18,20) | 6.2 Percentage of glycosylated hemoglobin | Standard Deviation 1.4 |
| Group 4: Tacrolimus + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: DM at BL (n=15, 11, 7, 11, 12) | 6.2 Percentage of glycosylated hemoglobin | Standard Deviation 0.96 |
| Group 4: Tacrolimus + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: DM at BL/DM at 12 mth (n=23,13 ,11,18,20) | 6.0 Percentage of glycosylated hemoglobin | Standard Deviation 0.84 |
| Group 4: Tacrolimus + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: DM at BL (n=15, 12, 10, 12, 10) | 5.8 Percentage of glycosylated hemoglobin | Standard Deviation 1.19 |
| Group 4: Tacrolimus + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: DM at BL/DM at 6m (n=23, 14, 14, 19, 18) | 5.5 Percentage of glycosylated hemoglobin | Standard Deviation 1.04 |
| Group 4: Tacrolimus + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: All participants (n=40, 35, 35, 44, 37) | 5.5 Percentage of glycosylated hemoglobin | Standard Deviation 0.76 |
| Group 4: Tacrolimus + MMF | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: All participants (n=39, 34, 38, 47, 35) | 5.4 Percentage of glycosylated hemoglobin | Standard Deviation 0.9 |
| Group 5: Tacrolimus | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: DM at BL/DM at 12 mth (n=23,13 ,11,18,20) | 6.3 Percentage of glycosylated hemoglobin | Standard Deviation 2.39 |
| Group 5: Tacrolimus | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: All participants (n=39, 34, 38, 47, 35) | 5.4 Percentage of glycosylated hemoglobin | Standard Deviation 0.84 |
| Group 5: Tacrolimus | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: DM at BL (n=15, 12, 10, 12, 10) | 5.4 Percentage of glycosylated hemoglobin | Standard Deviation 0.59 |
| Group 5: Tacrolimus | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 6 mo: DM at BL/DM at 6m (n=23, 14, 14, 19, 18) | 5.4 Percentage of glycosylated hemoglobin | Standard Deviation 0.62 |
| Group 5: Tacrolimus | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: All participants (n=40, 35, 35, 44, 37) | 5.8 Percentage of glycosylated hemoglobin | Standard Deviation 1.85 |
| Group 5: Tacrolimus | Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase | 12 mo: DM at BL (n=15, 11, 7, 11, 12) | 6.5 Percentage of glycosylated hemoglobin | Standard Deviation 3.05 |
Secondary
Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase
GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine (ScR), age, race, gender, blood urea nitrogen (BUN), and albumin (Alb). GFR (mL/min/1.73 m\^2) = 170\*(Scr)\^-0.999\*(Age)\^-0.176\*(0.762 if female)\*(1.180 if African American)\*(BUN)\^-0.170\*(Alb)\^+0.318. ). BL= baseline, mL= milliliters; min= minute; m\^2= meters squared.
Time frame: Baseline [BL] (pretransplant time point), 1, 2, 3, 6 and 12 months posttransplant
Population: ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 6 months; (n=37, 30, 33, 42, 31) | 18.6 mL/min/1.73 m^2 | Standard Deviation 31.06 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 2 months; (n=28, 26, 20, 22, 25) | 25.3 mL/min/1.73 m^2 | Standard Deviation 32.35 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 6 months; (n=39, 34, 38, 49, 36) | 82.2 mL/min/1.73 m^2 | Standard Deviation 23.88 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 2 months; (n=29, 30, 23, 25, 27) | 86.1 mL/min/1.73 m^2 | Standard Deviation 21.78 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 12 month; (n=37, 29, 30, 41, 33) | 18.2 mL/min/1.73 m^2 | Standard Deviation 27.63 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 1 month; (n=45, 44, 42, 49, 49) | 85.6 mL/min/1.73 m^2 | Standard Deviation 25.27 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 3 months; (n=36, 36, 35, 46, 37) | 86.5 mL/min/1.73 m^2 | Standard Deviation 21.2 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 1 month; (n=43, 38, 37, 41, 45) | 21.0 mL/min/1.73 m^2 | Standard Deviation 33.76 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | BL; (n=47, 42, 42, 45, 45) | 66.3 mL/min/1.73 m^2 | Standard Deviation 29.14 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 12 months; (n=40, 33, 35, 46, 38) | 83.8 mL/min/1.73 m^2 | Standard Deviation 22.18 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 3 months; (n=33, 34, 30, 40, 33) | 22.0 mL/min/1.73 m^2 | Standard Deviation 29.04 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 6 months; (n=37, 30, 33, 42, 31) | 7.6 mL/min/1.73 m^2 | Standard Deviation 31.43 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 3 months; (n=33, 34, 30, 40, 33) | 13.3 mL/min/1.73 m^2 | Standard Deviation 31.5 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 6 months; (n=39, 34, 38, 49, 36) | 90.3 mL/min/1.73 m^2 | Standard Deviation 24.23 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 1 month; (n=43, 38, 37, 41, 45) | 15.3 mL/min/1.73 m^2 | Standard Deviation 44.72 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 2 months; (n=29, 30, 23, 25, 27) | 96.6 mL/min/1.73 m^2 | Standard Deviation 27.78 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | BL; (n=47, 42, 42, 45, 45) | 77.4 mL/min/1.73 m^2 | Standard Deviation 33.42 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 12 month; (n=37, 29, 30, 41, 33) | 19.2 mL/min/1.73 m^2 | Standard Deviation 30.05 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 2 months; (n=28, 26, 20, 22, 25) | 18.3 mL/min/1.73 m^2 | Standard Deviation 33.35 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 12 months; (n=40, 33, 35, 46, 38) | 97.7 mL/min/1.73 m^2 | Standard Deviation 23.8 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 3 months; (n=36, 36, 35, 46, 37) | 91.7 mL/min/1.73 m^2 | Standard Deviation 26.83 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 1 month; (n=45, 44, 42, 49, 49) | 93.1 mL/min/1.73 m^2 | Standard Deviation 35.66 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | BL; (n=47, 42, 42, 45, 45) | 76.6 mL/min/1.73 m^2 | Standard Deviation 27.77 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 1 month; (n=45, 44, 42, 49, 49) | 89.6 mL/min/1.73 m^2 | Standard Deviation 28.47 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 1 month; (n=43, 38, 37, 41, 45) | 11.4 mL/min/1.73 m^2 | Standard Deviation 31.34 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 2 months; (n=28, 26, 20, 22, 25) | 31.5 mL/min/1.73 m^2 | Standard Deviation 26.89 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 3 months; (n=36, 36, 35, 46, 37) | 96.6 mL/min/1.73 m^2 | Standard Deviation 27.02 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 3 months; (n=33, 34, 30, 40, 33) | 18.3 mL/min/1.73 m^2 | Standard Deviation 26.92 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 6 months; (n=39, 34, 38, 49, 36) | 86.0 mL/min/1.73 m^2 | Standard Deviation 28.74 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 6 months; (n=37, 30, 33, 42, 31) | 5.6 mL/min/1.73 m^2 | Standard Deviation 26.78 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 12 months; (n=40, 33, 35, 46, 38) | 85.6 mL/min/1.73 m^2 | Standard Deviation 31.23 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 12 month; (n=37, 29, 30, 41, 33) | 4.2 mL/min/1.73 m^2 | Standard Deviation 30.4 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 2 months; (n=29, 30, 23, 25, 27) | 105.8 mL/min/1.73 m^2 | Standard Deviation 31.98 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 1 month; (n=45, 44, 42, 49, 49) | 64.9 mL/min/1.73 m^2 | Standard Deviation 26.31 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 6 months; (n=37, 30, 33, 42, 31) | -11.7 mL/min/1.73 m^2 | Standard Deviation 30.61 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 3 months; (n=36, 36, 35, 46, 37) | 65.0 mL/min/1.73 m^2 | Standard Deviation 19.93 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 12 months; (n=40, 33, 35, 46, 38) | 68.4 mL/min/1.73 m^2 | Standard Deviation 26.09 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 2 months; (n=28, 26, 20, 22, 25) | -1.5 mL/min/1.73 m^2 | Standard Deviation 52.78 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 12 month; (n=37, 29, 30, 41, 33) | -6.3 mL/min/1.73 m^2 | Standard Deviation 40.08 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 2 months; (n=29, 30, 23, 25, 27) | 76.3 mL/min/1.73 m^2 | Standard Deviation 35.25 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | BL; (n=47, 42, 42, 45, 45) | 73.7 mL/min/1.73 m^2 | Standard Deviation 32.42 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 1 month; (n=43, 38, 37, 41, 45) | -8.7 mL/min/1.73 m^2 | Standard Deviation 33.91 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 6 months; (n=39, 34, 38, 49, 36) | 61.9 mL/min/1.73 m^2 | Standard Deviation 20.62 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 3 months; (n=33, 34, 30, 40, 33) | -8.4 mL/min/1.73 m^2 | Standard Deviation 30.89 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 6 months; (n=39, 34, 38, 49, 36) | 59.8 mL/min/1.73 m^2 | Standard Deviation 22.37 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 12 month; (n=37, 29, 30, 41, 33) | -17.1 mL/min/1.73 m^2 | Standard Deviation 28.61 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 6 months; (n=37, 30, 33, 42, 31) | -22.7 mL/min/1.73 m^2 | Standard Deviation 29.63 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 1 month; (n=45, 44, 42, 49, 49) | 62.2 mL/min/1.73 m^2 | Standard Deviation 31.94 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 2 months; (n=28, 26, 20, 22, 25) | -14.0 mL/min/1.73 m^2 | Standard Deviation 34.03 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | BL; (n=47, 42, 42, 45, 45) | 80.2 mL/min/1.73 m^2 | Standard Deviation 30.78 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 1 month; (n=43, 38, 37, 41, 45) | -17.7 mL/min/1.73 m^2 | Standard Deviation 40.65 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 12 months; (n=40, 33, 35, 46, 38) | 63.8 mL/min/1.73 m^2 | Standard Deviation 21.24 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 3 months; (n=36, 36, 35, 46, 37) | 60.4 mL/min/1.73 m^2 | Standard Deviation 22.98 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | 2 months; (n=29, 30, 23, 25, 27) | 66.9 mL/min/1.73 m^2 | Standard Deviation 28.42 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase | Change from BL to 3 months; (n=33, 34, 30, 40, 33) | -20.2 mL/min/1.73 m^2 | Standard Deviation 32.08 |
Secondary
Mean Change From Baseline in Calculated GFR During the LTE
GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine (ScR), age, race, gender, blood urea nitrogen (BUN), and albumin (Alb). GFR (mL/min/1.73 m\^2) = 170\*(Scr)\^-0.999\*(Age)\^-0.176\*(0.762 if female)\*(1.180 if African American)\*(BUN)\^-0.170\*(Alb)\^+0.318. ). BL= baseline, mL= milliliters; min= minute; m\^2= meters squared.
Time frame: Baseline (pretransplant time point), 1, 2, 3, 6,12, 18, 24, 30, 36 months posttransplant
Population: ITT-LTE population, all randomized and transplanted participants who entered long term extension. n= participants who have both baseline and postbaseline values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 18 months; (n=21, 23, 17, 28,18) | 22.5 mL/min/1.73 m^2 | Standard Deviation 34.16 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 2 months; (n=20,19,14,17,18) | 26.0 mL/min/1.73 m^2 | Standard Deviation 34.74 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 30 months; (n=5, 5, 3, 8, 6) | 41.4 mL/min/1.73 m^2 | Standard Deviation 33.98 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Baseline (BL); (n=27,24,20,33,23) | 64.4 mL/min/1.73 m^2 | Standard Deviation 32.98 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 24 months; (n=10, 13, 11, 19,13) | 27.9 mL/min/1.73 m^2 | Standard Deviation 33.76 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 18 months; (n=24, 25, 21, 33, 21) | 84.8 mL/min/1.73 m^2 | Standard Deviation 24.1 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 3 months; (n=27, 26, 24, 35, 24) | 87.0 mL/min/1.73 m^2 | Standard Deviation 22.3 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 1 month; (n=28,27,23,36,25) | 88.2 mL/min/1.73 m^2 | Standard Deviation 24.56 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 24 months; (n=13, 15, 15, 22, 15) | 84.8 mL/min/1.73 m^2 | Standard Deviation 26.18 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 12 months; (n=29, 25, 24, 36, 24) | 88.1 mL/min/1.73 m^2 | Standard Deviation 21.45 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 3 months; (n=24, 24, 20, 30, 21) | 23.3 mL/min/1.73 m^2 | Standard Deviation 32.2 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 2 months; (n=21,21,15,19,19) | 86.2 mL/min/1.73 m^2 | Standard Deviation 22.29 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 6 months; (n=29, 26, 24, 24, 38, 23) | 87.6 mL/min/1.73 m^2 | Standard Deviation 23.93 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 12 months; (n=26, 23, 20, 31,21) | 22.6 mL/min/1.73 m^2 | Standard Deviation 29.57 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 1 month; (n=26,24,20,31,23) | 26.3 mL/min/1.73 m^2 | Standard Deviation 30.52 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 6 months; (n=27, 23, 20, 33, 20) | 24.0 mL/min/1.73 m^2 | Standard Deviation 33.34 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | At 30 months; (n=6, 6, 6, 12, 7) | 102.9 mL/min/1.73 m^2 | Standard Deviation 20.92 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 6 months; (n=27, 23, 20, 33, 20) | 8.6 mL/min/1.73 m^2 | Standard Deviation 31.89 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 18 months; (n=24, 25, 21, 33, 21) | 95.0 mL/min/1.73 m^2 | Standard Deviation 24.54 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 12 months; (n=29, 25, 24, 36, 24) | 101.3 mL/min/1.73 m^2 | Standard Deviation 25.01 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 12 months; (n=26, 23, 20, 31,21) | 19.4 mL/min/1.73 m^2 | Standard Deviation 30.28 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 1 month; (n=26,24,20,31,23) | 20.2 mL/min/1.73 m^2 | Standard Deviation 52.6 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 3 months; (n=27, 26, 24, 35, 24) | 97.0 mL/min/1.73 m^2 | Standard Deviation 26.14 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 30 months; (n=5, 5, 3, 8, 6) | 40.4 mL/min/1.73 m^2 | Standard Deviation 38.1 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | At 30 months; (n=6, 6, 6, 12, 7) | 94.4 mL/min/1.73 m^2 | Standard Deviation 31.78 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 2 months; (n=21,21,15,19,19) | 99.4 mL/min/1.73 m^2 | Standard Deviation 29.58 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 24 months; (n=10, 13, 11, 19,13) | 9.9 mL/min/1.73 m^2 | Standard Deviation 37.62 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 2 months; (n=20,19,14,17,18) | 12.6 mL/min/1.73 m^2 | Standard Deviation 30.12 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 24 months; (n=13, 15, 15, 22, 15) | 87.6 mL/min/1.73 m^2 | Standard Deviation 21.43 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 18 months; (n=21, 23, 17, 28,18) | 11.2 mL/min/1.73 m^2 | Standard Deviation 34.07 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 3 months; (n=24, 24, 20, 30, 21) | 13.7 mL/min/1.73 m^2 | Standard Deviation 32.38 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 6 months; (n=29, 26, 24, 24, 38, 23) | 93.1 mL/min/1.73 m^2 | Standard Deviation 23.45 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 1 month; (n=28,27,23,36,25) | 103.1 mL/min/1.73 m^2 | Standard Deviation 38.89 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Baseline (BL); (n=27,24,20,33,23) | 85.6 mL/min/1.73 m^2 | Standard Deviation 34.74 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 2 months; (n=20,19,14,17,18) | 30.7 mL/min/1.73 m^2 | Standard Deviation 29.13 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Baseline (BL); (n=27,24,20,33,23) | 78.0 mL/min/1.73 m^2 | Standard Deviation 31.65 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 1 month; (n=28,27,23,36,25) | 95.1 mL/min/1.73 m^2 | Standard Deviation 26.7 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 1 month; (n=26,24,20,31,23) | 16.0 mL/min/1.73 m^2 | Standard Deviation 31.53 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 2 months; (n=21,21,15,19,19) | 102.3 mL/min/1.73 m^2 | Standard Deviation 32.44 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 3 months; (n=27, 26, 24, 35, 24) | 97.0 mL/min/1.73 m^2 | Standard Deviation 25.94 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 6 months; (n=29, 26, 24, 24, 38, 23) | 92.3 mL/min/1.73 m^2 | Standard Deviation 24.71 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 6 months; (n=27, 23, 20, 33, 20) | 12.2 mL/min/1.73 m^2 | Standard Deviation 21.59 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 12 months; (n=29, 25, 24, 36, 24) | 94.8 mL/min/1.73 m^2 | Standard Deviation 27.89 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 12 months; (n=26, 23, 20, 31,21) | 16.5 mL/min/1.73 m^2 | Standard Deviation 24.91 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 18 months; (n=24, 25, 21, 33, 21) | 91.3 mL/min/1.73 m^2 | Standard Deviation 25.35 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 18 months; (n=21, 23, 17, 28,18) | 7.4 mL/min/1.73 m^2 | Standard Deviation 20.11 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 24 months; (n=13, 15, 15, 22, 15) | 96.3 mL/min/1.73 m^2 | Standard Deviation 26.02 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 24 months; (n=10, 13, 11, 19,13) | 15.2 mL/min/1.73 m^2 | Standard Deviation 19.64 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | At 30 months; (n=6, 6, 6, 12, 7) | 90.4 mL/min/1.73 m^2 | Standard Deviation 22.76 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 30 months; (n=5, 5, 3, 8, 6) | 17.1 mL/min/1.73 m^2 | Standard Deviation 26.76 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 3 months; (n=24, 24, 20, 30, 21) | 17.0 mL/min/1.73 m^2 | Standard Deviation 27.99 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 6 months; (n=27, 23, 20, 33, 20) | -10.9 mL/min/1.73 m^2 | Standard Deviation 30.53 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Baseline (BL); (n=27,24,20,33,23) | 77.9 mL/min/1.73 m^2 | Standard Deviation 32.13 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 18 months; (n=21, 23, 17, 28,18) | -6.8 mL/min/1.73 m^2 | Standard Deviation 31.26 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 3 months; (n=27, 26, 24, 35, 24) | 66.5 mL/min/1.73 m^2 | Standard Deviation 20.36 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 24 months; (n=13, 15, 15, 22, 15) | 73.3 mL/min/1.73 m^2 | Standard Deviation 22.82 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 2 months; (n=20,19,14,17,18) | -11.6 mL/min/1.73 m^2 | Standard Deviation 36.28 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 3 months; (n=24, 24, 20, 30, 21) | -8.1 mL/min/1.73 m^2 | Standard Deviation 31.69 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 24 months; (n=10, 13, 11, 19,13) | -2.2 mL/min/1.73 m^2 | Standard Deviation 32.67 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 2 months; (n=21,21,15,19,19) | 71.2 mL/min/1.73 m^2 | Standard Deviation 18.88 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | At 30 months; (n=6, 6, 6, 12, 7) | 64.1 mL/min/1.73 m^2 | Standard Deviation 27.3 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 1 month; (n=26,24,20,31,23) | -7.6 mL/min/1.73 m^2 | Standard Deviation 37.19 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 6 months; (n=29, 26, 24, 24, 38, 23) | 64.6 mL/min/1.73 m^2 | Standard Deviation 20.43 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 30 months; (n=5, 5, 3, 8, 6) | -15.0 mL/min/1.73 m^2 | Standard Deviation 38.89 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 18 months; (n=24, 25, 21, 33, 21) | 69.0 mL/min/1.73 m^2 | Standard Deviation 22.84 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 1 month; (n=28,27,23,36,25) | 68.6 mL/min/1.73 m^2 | Standard Deviation 28.06 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 12 months; (n=26, 23, 20, 31,21) | -9.3 mL/min/1.73 m^2 | Standard Deviation 34.3 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Calculated GFR During the LTE | 12 months; (n=29, 25, 24, 36, 24) | 67.8 mL/min/1.73 m^2 | Standard Deviation 22.07 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | 12 months; (n=29, 25, 24, 36, 24) | 61.7 mL/min/1.73 m^2 | Standard Deviation 20.49 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | 1 month; (n=28,27,23,36,25) | 59.1 mL/min/1.73 m^2 | Standard Deviation 22.41 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | Baseline (BL); (n=27,24,20,33,23) | 83.0 mL/min/1.73 m^2 | Standard Deviation 35.8 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 18 months; (n=21, 23, 17, 28,18) | -6.1 mL/min/1.73 m^2 | Standard Deviation 22.8 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 12 months; (n=26, 23, 20, 31,21) | -20.2 mL/min/1.73 m^2 | Standard Deviation 27.65 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 2 months; (n=20,19,14,17,18) | -17.4 mL/min/1.73 m^2 | Standard Deviation 33.94 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | 6 months; (n=29, 26, 24, 24, 38, 23) | 56.7 mL/min/1.73 m^2 | Standard Deviation 20.37 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 30 months; (n=5, 5, 3, 8, 6) | -10.7 mL/min/1.73 m^2 | Standard Deviation 13.4 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | 24 months; (n=13, 15, 15, 22, 15) | 66.3 mL/min/1.73 m^2 | Standard Deviation 21.63 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | 3 months; (n=27, 26, 24, 35, 24) | 57.0 mL/min/1.73 m^2 | Standard Deviation 22.61 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | 2 months; (n=21,21,15,19,19) | 64.4 mL/min/1.73 m^2 | Standard Deviation 28.9 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | 18 months; (n=24, 25, 21, 33, 21) | 63.2 mL/min/1.73 m^2 | Standard Deviation 21.25 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | At 30 months; (n=6, 6, 6, 12, 7) | 59.5 mL/min/1.73 m^2 | Standard Deviation 20.47 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 24 months; (n=10, 13, 11, 19,13) | 2.3 mL/min/1.73 m^2 | Standard Deviation 24.58 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 6 months; (n=27, 23, 20, 33, 20) | -23.3 mL/min/1.73 m^2 | Standard Deviation 28.74 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 1 month; (n=26,24,20,31,23) | -22.6 mL/min/1.73 m^2 | Standard Deviation 25.62 |
| Group 5: Tacrolimus | Mean Change From Baseline in Calculated GFR During the LTE | Change from BL to 3 months; (n=24, 24, 20, 30, 21) | -23.5 mL/min/1.73 m^2 | Standard Deviation 30.57 |
Secondary
Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase
GFR was assessed using a true measure of glomerular filtration via iothalamate clearance test. The month 2 time point was selected as the baseline time point with respect to measured GFR due to logistical difficulty in obtaining measured GFR at the time of liver transplant and post-transplant renal function largely stabilizing by 2 months. All Measured GFR \> 200 were truncated at 200.
Time frame: Baseline (2 month), 12 months posttransplant
Population: ITT population: all randomized and transplanted subjects. n = participants who had both baseline and postbaseline values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | Change from 2 to 12 months (n=31, 29, 26, 36, 29) | 14.2 mL/min/1.73m^2 | Standard Deviation 40.64 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | 12 months (n=39, 35, 29, 40, 32) | 88.9 mL/min/1.73m^2 | Standard Deviation 36.34 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | 2 months (n=37, 36, 35, 41, 37) | 72.4 mL/min/1.73m^2 | Standard Deviation 29.5 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | 12 months (n=39, 35, 29, 40, 32) | 93.1 mL/min/1.73m^2 | Standard Deviation 38.99 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | 2 months (n=37, 36, 35, 41, 37) | 86.6 mL/min/1.73m^2 | Standard Deviation 37.38 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | Change from 2 to 12 months (n=31, 29, 26, 36, 29) | 5.8 mL/min/1.73m^2 | Standard Deviation 48.2 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | Change from 2 to 12 months (n=31, 29, 26, 36, 29) | -19.6 mL/min/1.73m^2 | Standard Deviation 49.56 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | 2 months (n=37, 36, 35, 41, 37) | 98.6 mL/min/1.73m^2 | Standard Deviation 41.89 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | 12 months (n=39, 35, 29, 40, 32) | 73.1 mL/min/1.73m^2 | Standard Deviation 36.82 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | 12 months (n=39, 35, 29, 40, 32) | 75.2 mL/min/1.73m^2 | Standard Deviation 46.89 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | 2 months (n=37, 36, 35, 41, 37) | 65.9 mL/min/1.73m^2 | Standard Deviation 35.52 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | Change from 2 to 12 months (n=31, 29, 26, 36, 29) | 5.3 mL/min/1.73m^2 | Standard Deviation 51.81 |
| Group 5: Tacrolimus | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | Change from 2 to 12 months (n=31, 29, 26, 36, 29) | 7.3 mL/min/1.73m^2 | Standard Deviation 31.59 |
| Group 5: Tacrolimus | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | 2 months (n=37, 36, 35, 41, 37) | 58.5 mL/min/1.73m^2 | Standard Deviation 33.96 |
| Group 5: Tacrolimus | Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase | 12 months (n=39, 35, 29, 40, 32) | 70.5 mL/min/1.73m^2 | Standard Deviation 29.59 |
Secondary
Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12
Measurement of SCr is commonly used as an indicator of renal function. High creatinine blood level is an indicator of deficient filtering by the kidney. SCr was determined at baseline and various post-baseline time points.
Time frame: Baseline (pretransplant time point), 1, 2, 3, 6 and 12 months posttransplant
Population: ITT population, all randomized and transplanted participants. n= participants who have both baseline and postbaseline values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 3 months; (n=36, 36, 35, 46, 37) | 0.9 mg/dL | Standard Deviation 0.27 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 3 months; (n=33, 34, 30, 40, 33) | -0.6 mg/dL | Standard Deviation 1.45 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Baseline (BL); (n=47, 42, 42, 45, 45) | 1.4 mg/dL | Standard Deviation 1.25 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 12 months; (n=37, 29, 30, 41,33) | -0.5 mg/dL | Standard Deviation 1.38 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 2 months; (n=29, 30, 23, 25, 27) | 0.9 mg/dL | Standard Deviation 0.21 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 12 months; (n=40, 33, 35, 46, 38) | 1.0 mg/dL | Standard Deviation 0.26 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 6 months; (n=37, 30, 33, 42, 31) | -0.5 mg/dL | Standard Deviation 1.39 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 1 months; (n=45, 44, 42, 49, 49) | 0.9 mg/dL | Standard Deviation 0.38 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 2 months; (n=28, 26, 20, 22, 25) | -0.7 mg/dL | Standard Deviation 1.54 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 1 months; (n=43, 38, 37, 41, 45) | -0.5 mg/dL | Standard Deviation 1.35 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 6 months; (n=39, 34, 38, 49, 36) | 1.0 mg/dL | Standard Deviation 0.3 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 12 months; (n=40, 33, 35, 46, 38) | 0.8 mg/dL | Standard Deviation 0.16 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 3 months; (n=33, 34, 30, 40, 33) | -0.1 mg/dL | Standard Deviation 0.44 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 3 months; (n=36, 36, 35, 46, 37) | 0.9 mg/dL | Standard Deviation 0.21 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 1 months; (n=45, 44, 42, 49, 49) | 0.8 mg/dL | Standard Deviation 0.32 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Baseline (BL); (n=47, 42, 42, 45, 45) | 1.0 mg/dL | Standard Deviation 0.39 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 6 months; (n=37, 30, 33, 42, 31) | 0.0 mg/dL | Standard Deviation 0.41 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 1 months; (n=43, 38, 37, 41, 45) | -0.1 mg/dL | Standard Deviation 0.5 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 12 months; (n=37, 29, 30, 41,33) | -0.2 mg/dL | Standard Deviation 0.42 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 2 months; (n=29, 30, 23, 25, 27) | 0.8 mg/dL | Standard Deviation 0.22 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 6 months; (n=39, 34, 38, 49, 36) | 0.9 mg/dL | Standard Deviation 0.2 |
| Group 2: Belatacept (MI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 2 months; (n=28, 26, 20, 22, 25) | -0.2 mg/dL | Standard Deviation 0.32 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 3 months; (n=36, 36, 35, 46, 37) | 0.8 mg/dL | Standard Deviation 0.24 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Baseline (BL); (n=47, 42, 42, 45, 45) | 0.9 mg/dL | Standard Deviation 0.38 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 1 months; (n=45, 44, 42, 49, 49) | 0.9 mg/dL | Standard Deviation 0.42 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 1 months; (n=43, 38, 37, 41, 45) | -0.1 mg/dL | Standard Deviation 0.48 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 2 months; (n=28, 26, 20, 22, 25) | -0.2 mg/dL | Standard Deviation 0.32 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 3 months; (n=33, 34, 30, 40, 33) | -0.1 mg/dL | Standard Deviation 0.32 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 6 months; (n=39, 34, 38, 49, 36) | 0.9 mg/dL | Standard Deviation 0.42 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 12 months; (n=40, 33, 35, 46, 38) | 1.0 mg/dL | Standard Deviation 0.37 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 12 months; (n=37, 29, 30, 41,33) | 0.1 mg/dL | Standard Deviation 0.47 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 2 months; (n=29, 30, 23, 25, 27) | 0.8 mg/dL | Standard Deviation 0.28 |
| Group 3: Belatacept (LI) + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 6 months; (n=37, 30, 33, 42, 31) | 0.1 mg/dL | Standard Deviation 0.43 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 2 months; (n=28, 26, 20, 22, 25) | 0.0 mg/dL | Standard Deviation 0.73 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 2 months; (n=29, 30, 23, 25, 27) | 1.0 mg/dL | Standard Deviation 0.3 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 6 months; (n=37, 30, 33, 42, 31) | 0.2 mg/dL | Standard Deviation 0.6 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Baseline (BL); (n=47, 42, 42, 45, 45) | 1.1 mg/dL | Standard Deviation 0.54 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 12 months; (n=40, 33, 35, 46, 38) | 1.2 mg/dL | Standard Deviation 0.49 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 1 months; (n=45, 44, 42, 49, 49) | 1.2 mg/dL | Standard Deviation 0.41 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 12 months; (n=37, 29, 30, 41,33) | 0.1 mg/dL | Standard Deviation 0.63 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 1 months; (n=43, 38, 37, 41, 45) | 0.1 mg/dL | Standard Deviation 0.52 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 3 months; (n=36, 36, 35, 46, 37) | 1.2 mg/dL | Standard Deviation 0.36 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 6 months; (n=39, 34, 38, 49, 36) | 1.3 mg/dL | Standard Deviation 0.44 |
| Group 4: Tacrolimus + MMF | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 3 months; (n=33, 34, 30, 40, 33) | 0.1 mg/dL | Standard Deviation 0.5 |
| Group 5: Tacrolimus | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 3 months; (n=36, 36, 35, 46, 37) | 1.3 mg/dL | Standard Deviation 0.53 |
| Group 5: Tacrolimus | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 2 months; (n=29, 30, 23, 25, 27) | 1.2 mg/dL | Standard Deviation 0.36 |
| Group 5: Tacrolimus | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 1 months; (n=45, 44, 42, 49, 49) | 1.3 mg/dL | Standard Deviation 0.68 |
| Group 5: Tacrolimus | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 6 months; (n=39, 34, 38, 49, 36) | 1.3 mg/dL | Standard Deviation 0.51 |
| Group 5: Tacrolimus | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 3 months; (n=33, 34, 30, 40, 33) | 0.3 mg/dL | Standard Deviation 0.42 |
| Group 5: Tacrolimus | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 12 months; (n=37, 29, 30, 41,33) | 0.3 mg/dL | Standard Deviation 0.33 |
| Group 5: Tacrolimus | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 6 months; (n=37, 30, 33, 42, 31) | 0.4 mg/dL | Standard Deviation 0.5 |
| Group 5: Tacrolimus | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Baseline (BL); (n=47, 42, 42, 45, 45) | 1.0 mg/dL | Standard Deviation 0.4 |
| Group 5: Tacrolimus | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 2 months; (n=28, 26, 20, 22, 25) | 0.2 mg/dL | Standard Deviation 0.45 |
| Group 5: Tacrolimus | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | At 12 months; (n=40, 33, 35, 46, 38) | 1.2 mg/dL | Standard Deviation 0.32 |
| Group 5: Tacrolimus | Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12 | Change from BL to 1 months; (n=43, 38, 37, 41, 45) | 0.3 mg/dL | Standard Deviation 0.75 |
Secondary
Mean Change in Baseline Values of Cystatin C at 2 and 12 Months
Cystatin C is a protein encoded by the CST3 gene, which is mainly used as a biomarker of kidney function. If kidney function and glomerular filtration rate decline, the blood levels of cystatin C rise.
Time frame: Baseline (pretransplant), 2, and 12 months posttransplant
Population: ITT population: all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | 2 months; (n=40, 39, 39, 48, 43) | 1.1 mg/L | Standard Deviation 0.26 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | 12 months; (n=40, 36, 36, 49, 40) | 1.1 mg/L | Standard Deviation 0.36 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Baseline (BL); (n=44, 47, 48, 49, 43) | 1.2 mg/L | Standard Deviation 0.64 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Change from BL to 12 months; (n=35, 35, 35,45,34) | -0.2 mg/L | Standard Deviation 0.64 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Change from BL to 2 months; (n=35, 38, 38, 44,37) | -0.2 mg/L | Standard Deviation 0.62 |
| Group 2: Belatacept (MI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Change from BL to 12 months; (n=35, 35, 35,45,34) | -0.2 mg/L | Standard Deviation 0.63 |
| Group 2: Belatacept (MI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | 2 months; (n=40, 39, 39, 48, 43) | 1.1 mg/L | Standard Deviation 0.48 |
| Group 2: Belatacept (MI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | 12 months; (n=40, 36, 36, 49, 40) | 0.9 mg/L | Standard Deviation 0.28 |
| Group 2: Belatacept (MI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Change from BL to 2 months; (n=35, 38, 38, 44,37) | -0.1 mg/L | Standard Deviation 0.72 |
| Group 2: Belatacept (MI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Baseline (BL); (n=44, 47, 48, 49, 43) | 1.2 mg/L | Standard Deviation 0.57 |
| Group 3: Belatacept (LI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | 12 months; (n=40, 36, 36, 49, 40) | 1.2 mg/L | Standard Deviation 0.79 |
| Group 3: Belatacept (LI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Baseline (BL); (n=44, 47, 48, 49, 43) | 1.1 mg/L | Standard Deviation 0.39 |
| Group 3: Belatacept (LI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Change from BL to 12 months; (n=35, 35, 35,45,34) | 0.1 mg/L | Standard Deviation 0.86 |
| Group 3: Belatacept (LI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | 2 months; (n=40, 39, 39, 48, 43) | 1.0 mg/L | Standard Deviation 0.25 |
| Group 3: Belatacept (LI) + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Change from BL to 2 months; (n=35, 38, 38, 44,37) | -0.1 mg/L | Standard Deviation 0.31 |
| Group 4: Tacrolimus + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | 2 months; (n=40, 39, 39, 48, 43) | 1.4 mg/L | Standard Deviation 0.52 |
| Group 4: Tacrolimus + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Change from BL to 12 months; (n=35, 35, 35,45,34) | -0.1 mg/L | Standard Deviation 0.69 |
| Group 4: Tacrolimus + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Baseline (BL); (n=44, 47, 48, 49, 43) | 1.4 mg/L | Standard Deviation 0.73 |
| Group 4: Tacrolimus + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Change from BL to 2 months; (n=35, 38, 38, 44,37) | 0.1 mg/L | Standard Deviation 0.77 |
| Group 4: Tacrolimus + MMF | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | 12 months; (n=40, 36, 36, 49, 40) | 1.3 mg/L | Standard Deviation 0.53 |
| Group 5: Tacrolimus | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Change from BL to 12 months; (n=35, 35, 35,45,34) | 0.1 mg/L | Standard Deviation 0.63 |
| Group 5: Tacrolimus | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | 2 months; (n=40, 39, 39, 48, 43) | 1.5 mg/L | Standard Deviation 0.47 |
| Group 5: Tacrolimus | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Change from BL to 2 months; (n=35, 38, 38, 44,37) | 0.3 mg/L | Standard Deviation 0.7 |
| Group 5: Tacrolimus | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | 12 months; (n=40, 36, 36, 49, 40) | 1.3 mg/L | Standard Deviation 0.35 |
| Group 5: Tacrolimus | Mean Change in Baseline Values of Cystatin C at 2 and 12 Months | Baseline (BL); (n=44, 47, 48, 49, 43) | 1.2 mg/L | Standard Deviation 0.6 |
Secondary
Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months
The time from transplantation to the first AR episode in each treatment arm was summarized using Kaplan-Meier curves. Acute Rejections were clinically suspected and biopsy proven by central pathologist.
Time frame: 3, 6, 9 and 12 months posttransplant
Population: ITT population, all randomized and transplanted participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 3 months | 30 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 6 months | 27 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 9 months | 25 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 12 months | 23 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 3 months | 31 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 12 months | 25 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 6 months | 29 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 9 months | 29 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 12 months | 23 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 6 months | 28 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 9 months | 27 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 3 months | 30 participants |
| Group 4: Tacrolimus + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 3 months | 48 participants |
| Group 4: Tacrolimus + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 6 months | 47 participants |
| Group 4: Tacrolimus + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 12 months | 42 participants |
| Group 4: Tacrolimus + MMF | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 9 months | 47 participants |
| Group 5: Tacrolimus | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 12 months | 28 participants |
| Group 5: Tacrolimus | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 9 months | 32 participants |
| Group 5: Tacrolimus | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 6 months | 32 participants |
| Group 5: Tacrolimus | Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months | By 3 months | 34 participants |
Secondary
Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE
Acute Rejections were clinically suspected and biopsy proven by central pathologist. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI). An overall score of 0-2 is considered indeterminate, score of 3-4 is mild, score of 5-6 is moderate, and score of 7-9 is severe. Only the episode with the highest total RAI score for each participant was counted.
Time frame: Day 1 (randomization) through End of study (database lock of 20-June-2011)
Population: ITT-LTE population, all randomized and transplanted participants who entered the long-term extension phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Moderate Score | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Indeterminate score | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Indeterminate score | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Mild Score | 8 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Moderate Score | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Severe Score | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Severe Score | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Mild Score | 8 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Severe Score | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Moderate Score | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Indeterminate score | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Mild Score | 5 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Severe Score | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Indeterminate score | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Moderate Score | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Mild Score | 5 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Indeterminate score | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Mild Score | 2 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Severe Score | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Indeterminate score | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Moderate Score | 4 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Severe Score | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Moderate Score | 4 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Mild Score | 2 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Severe Score | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Moderate Score | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Mild Score | 5 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Mild Score | 5 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Indeterminate score | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Moderate Score | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Indeterminate score | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Severe Score | 0 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Indeterminate score | 0 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Moderate Score | 0 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Moderate Score | 0 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Severe Score | 2 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Indeterminate score | 0 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | By 12 months; Mild Score | 4 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Mild Score | 4 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE | At end of study; Severe Score | 2 participants |
Secondary
Number of Participants Having Acute Rejections: 12-month Treatment Phase
Acute rejections were clinically suspected and biopsy proven by central pathologist. The number of episodes of AR was counted.
Time frame: 3 , 6, and 12 months
Population: ITT population: all randomized and transplanted participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; 2 episodes | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; Overall | 17 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; >2 episodes | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; 2 episodes | 3 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; 1 episode | 15 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; 2 episodes | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; 1 episode | 18 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; >2 episodes | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; Overall | 22 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; 1 episode | 18 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; Overall | 20 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; >2 episodes | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; 2 episodes | 3 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; 1 episode | 13 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; >2 episodes | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; Overall | 15 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; 1 episode | 14 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; 2 episodes | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; >2 episodes | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; Overall | 15 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; 1 episode | 12 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; >2 episodes | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; 2 episodes | 3 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; Overall | 16 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; Overall | 14 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; >2 episodes | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; 1 episode | 14 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; Overall | 15 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; >2 episodes | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; 2 episodes | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; Overall | 16 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; >2 episodes | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; 1 episode | 14 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; 2 episodes | 2 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; 2 episodes | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; 1 episode | 14 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; 2 episodes | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; Overall | 7 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; 2 episodes | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; >2 episodes | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; 1 episode | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; >2 episodes | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; 1 episode | 6 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; >2 episodes | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; Overall | 5 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; Overall | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; 2 episodes | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; 1 episode | 4 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; >2 episodes | 0 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; Overall | 13 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; 1 episode | 13 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; 1 episode | 12 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; 2 episodes | 1 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 3 months ; >2 episodes | 0 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; Overall | 15 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; 2 episodes | 2 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 6 months ; >2 episodes | 0 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; Overall | 15 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; 1 episode | 13 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections: 12-month Treatment Phase | By 12 months ; 2 episodes | 2 participants |
Secondary
Number of Participants Having Acute Rejections During the LTE
Acute rejections were clinically suspected and biopsy proven by central pathologist. The number of episodes of AR was counted.
Time frame: Day 1 (randomization) through database lock (20-June-2011)
Population: ITT-LTE population, all randomized and transplanted participants who entered long-term extension
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 months (m); Overall | 9 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock; Overall | 9 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 m; >2 episodes | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock ; 2 episodes | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 m ; 1 episode | 8 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock ; >2 episodes | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock ; 1 episode | 8 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 m ; 2 episodes | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 m ; 2 episodes | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 m ; 1 episode | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock; Overall | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 m; >2 episodes | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 months (m); Overall | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock ; >2 episodes | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock ; 2 episodes | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock ; 1 episode | 6 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 m; >2 episodes | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 months (m); Overall | 6 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 m ; 1 episode | 5 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 m ; 2 episodes | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock ; >2 episodes | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock; Overall | 6 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock ; 1 episode | 5 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock ; 2 episodes | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 m ; 1 episode | 5 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock; Overall | 6 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 months (m); Overall | 6 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock ; >2 episodes | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock ; 2 episodes | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 m; >2 episodes | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections During the LTE | By Database lock ; 1 episode | 5 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Having Acute Rejections During the LTE | By 12 m ; 2 episodes | 1 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections During the LTE | By 12 m ; 2 episodes | 1 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections During the LTE | By Database lock ; 2 episodes | 0 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections During the LTE | By Database lock; Overall | 6 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections During the LTE | By 12 m ; 1 episode | 5 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections During the LTE | By Database lock ; >2 episodes | 1 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections During the LTE | By Database lock ; 1 episode | 5 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections During the LTE | By 12 months (m); Overall | 6 participants |
| Group 5: Tacrolimus | Number of Participants Having Acute Rejections During the LTE | By 12 m; >2 episodes | 0 participants |
Secondary
Number of Participants Who Had Abnormalities in Electrocardiograms: 12-month Treatment Phase
Time frame: Baseline (pretransplant), Week 52
Population: ECG data was not analyzed.
Secondary
Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months
Acute Rejections (AR) were clinically suspected and biopsy proven by central pathologist. The Banff grading is a classification of renal allograft pathology and AR. Grade I: AR requiring moderate (\>25%) to severe mononuclear cell interstitial infiltrate and moderate tubulitis; Grade II: AR requiring severe tubulitis and/or intimal arteritis; Grade III: AR requiring transmural arteritis. Only the episode with highest Banff grade for each participant was counted.
Time frame: 3, 6 and 12 months posttransplant
Population: ITT population: all randomized and transplanted participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 2 | 7 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 3 | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 1 | 16 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 3 | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 3 | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 2 | 4 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 1 | 15 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 2 | 3 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 1 | 14 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 2 | 8 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 3 | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 3 | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 1 | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 1 | 8 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 3 | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 2 | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 2 | 8 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 1 | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 2 | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 3 | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 3 | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 2 | 6 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 2 | 8 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 1 | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 1 | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 1 | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 3 | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 1 | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 2 | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 3 | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 3 | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 2 | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 1 | 6 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 3 | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 2 | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 1 | 3 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 3 | 2 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 1 | 6 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 3 | 2 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 2 | 6 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 3 | 2 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 1 | 7 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 3 months: Grade 2 | 5 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 6 months: Grade 1 | 7 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months | By 12 months: Grade 2 | 6 participants |
Secondary
Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase
AE of of special interest included malignancies (including skin carcinomas), infections (viral, cytomegalovirus, herpes, fungal, and bacterial), serious infections
Time frame: Day 1 (randomization) to 12 months or ≤ 56 days after discontinuation of study medication
Population: ITT population, all randomized and transplanted participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Polyoma virus infections | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Viral infections | 10 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | All Infections | 32 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Cytomegalovirus infections | 5 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Post-transplant lymphoproliferative disorder | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Bacterial infections | 5 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Thrombotic and embolic events | 3 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Malignancies | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Autoimmune events | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Serious infections | 11 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Fungal infections | 6 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Acute peri-infusional events | 5 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Hepatitis C virus recurrence | 14 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Herpes infections | 3 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Viral infections | 11 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | All Infections | 39 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Bacterial infections | 11 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Fungal infections | 9 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Cytomegalovirus infections | 4 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Polyoma virus infections | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Herpes infections | 3 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Hepatitis C virus recurrence | 7 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Serious infections | 12 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Autoimmune events | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Malignancies | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Post-transplant lymphoproliferative disorder | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Acute peri-infusional events | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Thrombotic and embolic events | 3 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Thrombotic and embolic events | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Polyoma virus infections | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | All Infections | 30 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Autoimmune events | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Bacterial infections | 11 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Malignancies | 2 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Cytomegalovirus infections | 10 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Fungal infections | 14 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Acute peri-infusional events | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Viral infections | 14 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Hepatitis C virus recurrence | 6 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Post-transplant lymphoproliferative disorder | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Serious infections | 13 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Herpes infections | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Post-transplant lymphoproliferative disorder | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Fungal infections | 6 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Herpes infections | 3 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Acute peri-infusional events | NA participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Serious infections | 12 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Bacterial infections | 6 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Malignancies | 2 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Polyoma virus infections | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Hepatitis C virus recurrence | 13 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Autoimmune events | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Viral infections | 9 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | All Infections | 31 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Cytomegalovirus infections | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Thrombotic and embolic events | 10 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Bacterial infections | 13 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Herpes infections | 2 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Polyoma virus infections | 0 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Autoimmune events | 2 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Cytomegalovirus infections | 1 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Viral infections | 7 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Thrombotic and embolic events | 5 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Hepatitis C virus recurrence | 9 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Malignancies | 2 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | All Infections | 29 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Serious infections | 12 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Acute peri-infusional events | NA participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Fungal infections | 5 participants |
| Group 5: Tacrolimus | Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase | Post-transplant lymphoproliferative disorder | 0 participants |
Secondary
Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event
Time frame: Day 1 (randomization) to 12 m + 8 week follow-up or ≤ 56 days after discontinuation of study medication
Population: ITT population: all randomized and transplanted participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Death | 4 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Discontinued due to SAEs | 7 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Related SAEs | 12 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Discontinued due to AEs | 7 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Related AEs | 45 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | AEs | 50 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | SAEs | 28 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Discontinued due to AEs | 7 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Death | 4 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | SAEs | 29 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Related SAEs | 11 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Discontinued due to SAEs | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | AEs | 48 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Related AEs | 34 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Related AEs | 33 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | SAEs | 37 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | AEs | 48 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Discontinued due to AEs | 12 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Discontinued due to SAEs | 11 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Related SAEs | 14 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Death | 9 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | AEs | 53 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Discontinued due to SAEs | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Discontinued due to AEs | 7 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Related SAEs | 16 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Death | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Related AEs | 42 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | SAEs | 40 participants |
| Group 5: Tacrolimus | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Death | 4 participants |
| Group 5: Tacrolimus | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Discontinued due to SAEs | 13 participants |
| Group 5: Tacrolimus | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Related AEs | 42 participants |
| Group 5: Tacrolimus | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | SAEs | 35 participants |
| Group 5: Tacrolimus | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | AEs | 50 participants |
| Group 5: Tacrolimus | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Related SAEs | 19 participants |
| Group 5: Tacrolimus | Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase | Discontinued due to AEs | 18 participants |
Secondary
Number of Participants Who Received Anti-hypertensive Therapy at Month 12
Time frame: 12 months posttransplant
Population: ITT population, all randomized and transplanted participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 3 medications | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received at least 1 medication | 20 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 4 medications | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 1 medication | 13 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 2 medications | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 3 medications | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 2 medications | 2 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 1 medication | 16 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 4 medications | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received at least 1 medication | 19 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 2 medications | 2 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received at least 1 medication | 14 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 1 medication | 8 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 3 medications | 4 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 4 medications | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 4 medications | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received at least 1 medication | 26 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 3 medications | 3 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 2 medications | 5 participants |
| Group 4: Tacrolimus + MMF | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 1 medication | 17 participants |
| Group 5: Tacrolimus | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 2 medications | 5 participants |
| Group 5: Tacrolimus | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 3 medications | 3 participants |
| Group 5: Tacrolimus | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received at least 1 medication | 21 participants |
| Group 5: Tacrolimus | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 4 medications | 1 participants |
| Group 5: Tacrolimus | Number of Participants Who Received Anti-hypertensive Therapy at Month 12 | Received 1 medication | 12 participants |
Secondary
Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase
Recurrent hepatitis C infection of the allograft following liver transplantation can be detected by monitoring HCV RNA levels. In HCV positive participants, quantitative HCV RNA levels \> 2.4 \* 10\^6 U/mL and \> 4.7 \* 10\^6 U/mL were descriptively summarized by treatment group. BL=baseline
Time frame: Baseline (pretransplant), 6 and 12 months (mo) posttransplant
Population: ITT population, all randomized and transplanted participants. n= participants who were HCV positive at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | BL; HCV RNA > 2.4*10^6 U/mL (n=21,22,19,22,23) | 2 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | BL; HCV RNA > 4.7 *10^6 U/mL (n=21,22,19,22,23) | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 12 mo; HCV RNA > 4.7*10^6 U/mL (n=15,13,14,20,13) | 6 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 12 mo; HCV RNA > 2.4*10^6 U/mL (n=15,13,14,20,13) | 7 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 6 mo; HCV RNA > 4.7*10^6 U/mL (n=16,15,15,21,14) | 7 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 6 mo; HCV RNA > 2.4*10^6 U/mL (n=16,15,15,21,14) | 9 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 6 mo; HCV RNA > 4.7*10^6 U/mL (n=16,15,15,21,14) | 7 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 6 mo; HCV RNA > 2.4*10^6 U/mL (n=16,15,15,21,14) | 7 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | BL; HCV RNA > 4.7 *10^6 U/mL (n=21,22,19,22,23) | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 12 mo; HCV RNA > 4.7*10^6 U/mL (n=15,13,14,20,13) | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | BL; HCV RNA > 2.4*10^6 U/mL (n=21,22,19,22,23) | 4 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 12 mo; HCV RNA > 2.4*10^6 U/mL (n=15,13,14,20,13) | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | BL; HCV RNA > 4.7 *10^6 U/mL (n=21,22,19,22,23) | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 6 mo; HCV RNA > 2.4*10^6 U/mL (n=16,15,15,21,14) | 8 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | BL; HCV RNA > 2.4*10^6 U/mL (n=21,22,19,22,23) | 2 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 6 mo; HCV RNA > 4.7*10^6 U/mL (n=16,15,15,21,14) | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 12 mo; HCV RNA > 2.4*10^6 U/mL (n=15,13,14,20,13) | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 12 mo; HCV RNA > 4.7*10^6 U/mL (n=15,13,14,20,13) | 5 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 6 mo; HCV RNA > 2.4*10^6 U/mL (n=16,15,15,21,14) | 14 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 12 mo; HCV RNA > 2.4*10^6 U/mL (n=15,13,14,20,13) | 13 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 6 mo; HCV RNA > 4.7*10^6 U/mL (n=16,15,15,21,14) | 11 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 12 mo; HCV RNA > 4.7*10^6 U/mL (n=15,13,14,20,13) | 11 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | BL; HCV RNA > 4.7 *10^6 U/mL (n=21,22,19,22,23) | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | BL; HCV RNA > 2.4*10^6 U/mL (n=21,22,19,22,23) | 3 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 6 mo; HCV RNA > 4.7*10^6 U/mL (n=16,15,15,21,14) | 10 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 6 mo; HCV RNA > 2.4*10^6 U/mL (n=16,15,15,21,14) | 11 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 12 mo; HCV RNA > 2.4*10^6 U/mL (n=15,13,14,20,13) | 7 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | BL; HCV RNA > 2.4*10^6 U/mL (n=21,22,19,22,23) | 1 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | 12 mo; HCV RNA > 4.7*10^6 U/mL (n=15,13,14,20,13) | 7 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase | BL; HCV RNA > 4.7 *10^6 U/mL (n=21,22,19,22,23) | 0 participants |
Secondary
Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE
Recurrent hepatitis C infection of the allograft following liver transplantation can be detected by monitoring HCV RNA levels. In HCV positive participants, quantitative HCV RNA levels \> 2.4 x 10\^6 U/mL and \> 4.7 x 10\^6 U/mL were descriptively summarized by treatment group. BL = baseline
Time frame: BL (pretransplant), 12, 18, 24, 30 months (mo) posttransplant
Population: ITT-LTE population, all randomized and transplanted participants. n= participants with HCV RNA values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 18 mo; HCV RNA > 2.4*10^6 U/mL (n=7,10,3,12,9) | 3 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 18 mo; HCV RNA > 4.7*10^6 U/mL (n=7,10,3,12,9) | 2 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 30 mo; HCV RNA > 2.4*10^6 U/mL (n=1,1,1,2,2) | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 12 mo; HCV RNA > 2.4*10^6 U/mL (n=11,10,8,16,10) | 6 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 30 mo; HCV RNA > 4.7*10^6 U/mL (n=1,1,1,2,2) | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 24 mo; HCV RNA > 4.7*10^6 U/mL (n=4,3,4,8,4) | 2 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 12 mo; HCV RNA > 4.7*10^6 U/mL (n=11,10,8,16,10) | 6 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | BL; HCV RNA > 2.4*10^6 U/mL (n=10,11,6,15,10) | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 24 mo; HCV RNA > 2.4*10^6 U/mL (n=4,3,4,8,4) | 2 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 12 mo; HCV RNA > 2.4*10^6 U/mL (n=11,10,8,16,10) | 5 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 18 mo; HCV RNA > 2.4*10^6 U/mL (n=7,10,3,12,9) | 2 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | BL; HCV RNA > 2.4*10^6 U/mL (n=10,11,6,15,10) | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 18 mo; HCV RNA > 4.7*10^6 U/mL (n=7,10,3,12,9) | 2 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 24 mo; HCV RNA > 2.4*10^6 U/mL (n=4,3,4,8,4) | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 30 mo; HCV RNA > 4.7*10^6 U/mL (n=1,1,1,2,2) | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 30 mo; HCV RNA > 2.4*10^6 U/mL (n=1,1,1,2,2) | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 24 mo; HCV RNA > 4.7*10^6 U/mL (n=4,3,4,8,4) | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 12 mo; HCV RNA > 4.7*10^6 U/mL (n=11,10,8,16,10) | 4 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 12 mo; HCV RNA > 2.4*10^6 U/mL (n=11,10,8,16,10) | 4 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | BL; HCV RNA > 2.4*10^6 U/mL (n=10,11,6,15,10) | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 30 mo; HCV RNA > 2.4*10^6 U/mL (n=1,1,1,2,2) | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 12 mo; HCV RNA > 4.7*10^6 U/mL (n=11,10,8,16,10) | 3 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 18 mo; HCV RNA > 2.4*10^6 U/mL (n=7,10,3,12,9) | 2 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 18 mo; HCV RNA > 4.7*10^6 U/mL (n=7,10,3,12,9) | 2 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 24 mo; HCV RNA > 2.4*10^6 U/mL (n=4,3,4,8,4) | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 24 mo; HCV RNA > 4.7*10^6 U/mL (n=4,3,4,8,4) | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 30 mo; HCV RNA > 4.7*10^6 U/mL (n=1,1,1,2,2) | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 18 mo; HCV RNA > 4.7*10^6 U/mL (n=7,10,3,12,9) | 6 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 12 mo; HCV RNA > 4.7*10^6 U/mL (n=11,10,8,16,10) | 8 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 30 mo; HCV RNA > 2.4*10^6 U/mL (n=1,1,1,2,2) | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 24 mo; HCV RNA > 2.4*10^6 U/mL (n=4,3,4,8,4) | 6 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 12 mo; HCV RNA > 2.4*10^6 U/mL (n=11,10,8,16,10) | 10 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 24 mo; HCV RNA > 4.7*10^6 U/mL (n=4,3,4,8,4) | 5 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | BL; HCV RNA > 2.4*10^6 U/mL (n=10,11,6,15,10) | 2 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 18 mo; HCV RNA > 2.4*10^6 U/mL (n=7,10,3,12,9) | 7 participants |
| Group 4: Tacrolimus + MMF | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 30 mo; HCV RNA > 4.7*10^6 U/mL (n=1,1,1,2,2) | 1 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 18 mo; HCV RNA > 2.4*10^6 U/mL (n=7,10,3,12,9) | 3 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 12 mo; HCV RNA > 4.7*10^6 U/mL (n=11,10,8,16,10) | 4 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 24 mo; HCV RNA > 4.7*10^6 U/mL (n=4,3,4,8,4) | 1 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | BL; HCV RNA > 2.4*10^6 U/mL (n=10,11,6,15,10) | 1 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 18 mo; HCV RNA > 4.7*10^6 U/mL (n=7,10,3,12,9) | 2 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 24 mo; HCV RNA > 2.4*10^6 U/mL (n=4,3,4,8,4) | 1 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 12 mo; HCV RNA > 2.4*10^6 U/mL (n=11,10,8,16,10) | 4 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 30 mo; HCV RNA > 2.4*10^6 U/mL (n=1,1,1,2,2) | 1 participants |
| Group 5: Tacrolimus | Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE | 30 mo; HCV RNA > 4.7*10^6 U/mL (n=1,1,1,2,2) | 1 participants |
Secondary
Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months
Acute Rejections were clinically suspected and biopsy proven by central pathologist. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI). An overall score of 0-2 is considered indeterminate, score of 3-4 is mild, score of 5-6 is moderate, and score of 7-9 is severe. Only the episode with the highest total RAI score for each participant was counted.
Time frame: 3, 6 and 12 months posttransplant
Population: ITT population: all randomized and transplanted participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Moderate Score | 4 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Indeterminate score | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Severe Score | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Indeterminate score | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Mild Score | 17 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Mild Score | 14 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Mild Score | 17 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Severe Score | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Indeterminate score | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Moderate Score | 3 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Moderate Score | 3 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Severe Score | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Moderate Score | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Mild Score | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Severe Score | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Severe Score | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Indeterminate score | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Mild Score | 7 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Moderate Score | 8 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Indeterminate score | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Indeterminate score | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Mild Score | 8 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Moderate Score | 8 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Severe Score | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Indeterminate score | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Severe Score | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Indeterminate score | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Mild Score | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Moderate Score | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Severe Score | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Indeterminate score | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Mild Score | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Moderate Score | 8 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Mild Score | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Moderate Score | 9 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Severe Score | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Severe Score | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Moderate Score | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Mild Score | 6 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Mild Score | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Indeterminate score | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Moderate Score | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Severe Score | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Indeterminate score | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Severe Score | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Indeterminate score | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Mild Score | 3 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Moderate Score | 1 participants |
| Group 5: Tacrolimus | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Moderate Score | 2 participants |
| Group 5: Tacrolimus | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Severe Score | 4 participants |
| Group 5: Tacrolimus | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Mild Score | 8 participants |
| Group 5: Tacrolimus | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Mild Score | 7 participants |
| Group 5: Tacrolimus | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Moderate Score | 3 participants |
| Group 5: Tacrolimus | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Indeterminate score | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Indeterminate score | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Severe Score | 4 participants |
| Group 5: Tacrolimus | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Mild Score | 8 participants |
| Group 5: Tacrolimus | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 12 months; Moderate Score | 3 participants |
| Group 5: Tacrolimus | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 3 months; Severe Score | 4 participants |
| Group 5: Tacrolimus | Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months | By 6 months; Indeterminate score | 0 participants |
Secondary
Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months
Acute rejections were clinically suspected and biopsy proven by central pathologist. Corticosteroid-resistant rejection = Continued rejection, as documented by liver biopsy, after the completion of 2 days of corticosteroids and requiring use of T-cell depleting agent. Refractory rejection=Continued rejection, as documented by liver biopsy, after use of corticosteroids and T cell depletion therapy. Increase in the dose of TAC was monitored in participants who were assigned to one of the TAC-based regimens. TRT= treatment
Time frame: 3, 6 and 12 months posttransplant
Population: ITT population: all randomized and transplanted participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Corticosteroid resistant | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By3 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Acute rejections | 7 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Refractory | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Treated participants | 10 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Corticosteroid resistant | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Corticosteroid treatment Only | 10 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | B12 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Increase in dose of Tacrolimus | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Corticosteroid treatment Only | 12 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Other / not available | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Increase in dose of Tacrolimus | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Refractory | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Corticosteroid resistant | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Acute rejections | 22 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Treated participants | 12 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Treated participants | 12 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Acute rejections | 20 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Corticosteroid treatment Only | 12 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Other / not available | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Refractory | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | 12 months: Other / not available | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Increase in dose of Tacrolimus | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By3 months: Initial lymphocyte depleting TRT | 2 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Corticosteroid resistant | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Corticosteroid treatment Only | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Acute rejections | 15 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Increase in dose of Tacrolimus | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Refractory | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Other / not available | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Acute rejections | 16 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Treated participants | 11 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Corticosteroid resistant | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Corticosteroid resistant | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Treated participants | 11 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | B12 months: Initial lymphocyte depleting TRT | 3 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Corticosteroid treatment Only | 7 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | 12 months: Other / not available | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Acute rejections | 15 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Initial lymphocyte depleting TRT | 3 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Corticosteroid treatment Only | 7 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Other / not available | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Treated participants | 12 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Refractory | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Refractory | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Acute rejections | 16 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Increase in dose of Tacrolimus | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Treated participants | 8 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Corticosteroid treatment Only | 8 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Corticosteroid resistant | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Refractory | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Increase in dose of Tacrolimus | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Other / not available | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Treated participants | 8 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Corticosteroid treatment Only | 8 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Corticosteroid resistant | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Refractory | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | 12 months: Other / not available | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Acute rejections | 14 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Treated participants | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Corticosteroid treatment Only | 7 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Corticosteroid resistant | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Refractory | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By3 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Other / not available | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Acute rejections | 15 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | B12 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Refractory | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By3 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Refractory | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Refractory | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | B12 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Acute rejections | 5 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Corticosteroid resistant | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Corticosteroid treatment Only | 3 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Increase in dose of Tacrolimus | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Corticosteroid resistant | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Acute rejections | 7 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Treated participants | 5 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Treated participants | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Acute rejections | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Increase in dose of Tacrolimus | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Corticosteroid treatment Only | 2 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Other / not available | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | 12 months: Other / not available | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Treated participants | 3 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Corticosteroid treatment Only | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Corticosteroid resistant | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Other / not available | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Corticosteroid resistant | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | 12 months: Other / not available | 1 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Refractory | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Corticosteroid resistant | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By3 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Other / not available | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Corticosteroid treatment Only | 10 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Treated participants | 2 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | B12 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Acute rejections | 15 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Refractory | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Corticosteroid treatment Only | 10 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Other / not available | 1 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Increase in dose of Tacrolimus | 1 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Refractory | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Corticosteroid resistant | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 6 months: Treated participants | 12 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 12 months: Acute rejections | 15 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Increase in dose of Tacrolimus | 1 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Corticosteroid treatment Only | 9 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Treated participants | 10 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months | By 3 months: Acute rejections | 13 participants |
Secondary
Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE
Acute rejections were clinically suspected and biopsy proven by central pathologist. Corticosteroid-resistant rejection = Continued rejection, as documented by liver biopsy, after the completion of 2 days of corticosteroids and requiring use of T-cell depleting agent. Refractory rejection=Continued rejection, as documented by liver biopsy, after use of corticosteroids and T cell depletion therapy. Increase in the dose of TAC was monitored in participants who were assigned to one of the TAC-based regimens. DBL=database lock, TRT=treatment
Time frame: Day 1 (randomization) through database lock (20-June-2011)
Population: ITT-LTE population, all randomized and transplanted participants who entered long term extension.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Other/ Not available | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Treated participants | 4 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Initial lymphocyte depleting treatment | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Corticosteroid resistant | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Acute rejections | 9 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Acute rejections | 9 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Increase in dose of TAC | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Corticosteroid treatment Only | 4 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Other / not available | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Corticosteroid resistant | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Refractory | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Refractory | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Treated participants | 4 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Increase in dose of TAC | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Corticosteroid treatment Only | 4 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Increase in dose of TAC | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Increase in dose of TAC | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Acute rejections | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Corticosteroid treatment Only | 4 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Other/ Not available | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Corticosteroid resistant | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Treated participants | 5 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Refractory | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Refractory | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Acute rejections | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Corticosteroid resistant | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Initial lymphocyte depleting TRT | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Corticosteroid treatment Only | 4 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Other / not available | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Initial lymphocyte depleting treatment | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Treated participants | 5 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Initial lymphocyte depleting treatment | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Treated participants | 4 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Corticosteroid treatment Only | 4 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Corticosteroid resistant | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Refractory | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Other / not available | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Increase in dose of TAC | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Acute rejections | 6 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Refractory | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Other/ Not available | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Increase in dose of TAC | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Acute rejections | 6 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Treated participants | 4 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Corticosteroid treatment Only | 4 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Corticosteroid resistant | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Corticosteroid treatment Only | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Other/ Not available | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Acute rejections | 6 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Increase in dose of TAC | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Corticosteroid resistant | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Acute rejections | 6 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Increase in dose of TAC | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Other / not available | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Corticosteroid treatment Only | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Treated participants | 5 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Refractory | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Treated participants | 5 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Corticosteroid resistant | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Refractory | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Initial lymphocyte depleting treatment | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Refractory | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Corticosteroid resistant | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Corticosteroid treatment Only | 5 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Other/ Not available | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Treated participants | 6 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Increase in dose of TAC | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Corticosteroid resistant | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Initial lymphocyte depleting TRT | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Increase in dose of TAC | 1 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Acute rejections | 6 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Treated participants | 6 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Acute rejections | 6 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Corticosteroid treatment Only | 5 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Refractory | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By 12 months: Other / not available | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE | By DBL: Initial lymphocyte depleting treatment | 0 participants |
Secondary
Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase
Low total calcium: \<7 mg/dL; High total calcium: \>12.5 mg/dL ; Low bicarbonate: \<11 mEq/L; Low serum potassium: \<3.0 mEq/L; High serum potassium:\>6.0 mEq/L; High serum magnesium: \>2.46 mEq/L; Low serum magnesium:\<0.8 mEq/L; Low serum sodium: \<130 mEq/L; High serum sodium: \>155 mEq/L; Low inorganic phosphorus: \<2.0 mg/dL; Low albumin: \<2 g/dL; High uric acid: \>10 mg/dL
Time frame: Baseline (pretransplant), Weeks 4, 12, 24, and 52
Population: ITT population, all randomized and transplanted participants. n= participants with all observations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Magnesium (n=48, 47, 44, 53, 50) | 2 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Total Calcium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Inorganic Phosphorus (n=48, 47, 44, 53, 50) | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Potassium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Sodium (n=48, 47, 44, 53, 50) | 3 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Albumin (n=47, 47, 45, 53, 50) | 2 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Bicarbonate (n=47, 47, 44, 53, 50) | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Sodium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Potassium (n=48, 47, 44, 53, 50) | 1 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Magnesium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Uric Acid (n=48, 47, 44, 53, 50) | 2 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Total Calcium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Sodium (n=48, 47, 44, 53, 50) | 2 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Magnesium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Magnesium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Total Calcium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Albumin (n=47, 47, 45, 53, 50) | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Bicarbonate (n=47, 47, 44, 53, 50) | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Total Calcium (n=48, 47, 44, 53, 50) | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Inorganic Phosphorus (n=48, 47, 44, 53, 50) | 2 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Potassium (n=48, 47, 44, 53, 50) | 2 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Uric Acid (n=48, 47, 44, 53, 50) | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Sodium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Potassium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Total Calcium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Total Calcium (n=48, 47, 44, 53, 50) | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Bicarbonate (n=47, 47, 44, 53, 50) | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Potassium (n=48, 47, 44, 53, 50) | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Potassium (n=48, 47, 44, 53, 50) | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Sodium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Magnesium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Magnesium (n=48, 47, 44, 53, 50) | 2 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Sodium (n=48, 47, 44, 53, 50) | 2 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Inorganic Phosphorus (n=48, 47, 44, 53, 50) | 1 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Albumin (n=47, 47, 45, 53, 50) | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Uric Acid (n=48, 47, 44, 53, 50) | 2 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Magnesium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Sodium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Potassium (n=48, 47, 44, 53, 50) | 2 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Total Calcium (n=48, 47, 44, 53, 50) | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Sodium (n=48, 47, 44, 53, 50) | 2 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Potassium (n=48, 47, 44, 53, 50) | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Bicarbonate (n=47, 47, 44, 53, 50) | 1 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Inorganic Phosphorus (n=48, 47, 44, 53, 50) | 2 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Total Calcium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Uric Acid (n=48, 47, 44, 53, 50) | 5 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Albumin (n=47, 47, 45, 53, 50) | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Magnesium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Magnesium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Inorganic Phosphorus (n=48, 47, 44, 53, 50) | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Total Calcium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Magnesium (n=48, 47, 44, 53, 50) | 1 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Potassium (n=48, 47, 44, 53, 50) | 1 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Sodium (n=48, 47, 44, 53, 50) | 2 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Serum Potassium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Total Calcium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Serum Sodium (n=48, 47, 44, 53, 50) | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Bicarbonate (n=47, 47, 44, 53, 50) | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | Low Albumin (n=47, 47, 45, 53, 50) | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase | High Uric Acid (n=48, 47, 44, 53, 50) | 5 participants |
Secondary
Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase
Low hemoglobin: \<8 g/dL; Low platelet count: \<50\*10\^9 C/L; Low leukocytes: \<2.0 \*10\^3 c/µL; Low lymphocytes (absolute): \<0.5\*10\^3 c/µL; Low neutrophils (absolute): \<1.0\*10\^3 Cc/µL.
Time frame: Baseline (pretransplant), 2, 4, 8, 12 weeks, and every 4 weeks for week 16 to 52
Population: ITT population, all randomized and transplanted participants. n= participants with all observations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Hemoglobin: (n=48, 46, 44, 52, 50) | 2 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Absolute Neutrophils : (n=48, 46, 44, 52, 50) | 6 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Platelets: (n=48, 46, 43, 52, 50) | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Leukocytes : (n=48, 46, 44, 52, 50) | 6 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Absolute Lymphocyte: (n=48, 46, 44, 52, 50) | 29 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Leukocytes : (n=48, 46, 44, 52, 50) | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Absolute Lymphocyte: (n=48, 46, 44, 52, 50) | 18 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Hemoglobin: (n=48, 46, 44, 52, 50) | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Platelets: (n=48, 46, 43, 52, 50) | 1 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Absolute Neutrophils : (n=48, 46, 44, 52, 50) | 4 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Platelets: (n=48, 46, 43, 52, 50) | 4 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Absolute Neutrophils : (n=48, 46, 44, 52, 50) | 4 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Hemoglobin: (n=48, 46, 44, 52, 50) | 2 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Leukocytes : (n=48, 46, 44, 52, 50) | 5 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Absolute Lymphocyte: (n=48, 46, 44, 52, 50) | 26 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Platelets: (n=48, 46, 43, 52, 50) | 2 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Absolute Lymphocyte: (n=48, 46, 44, 52, 50) | 17 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Absolute Neutrophils : (n=48, 46, 44, 52, 50) | 8 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Leukocytes : (n=48, 46, 44, 52, 50) | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Hemoglobin: (n=48, 46, 44, 52, 50) | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Hemoglobin: (n=48, 46, 44, 52, 50) | 6 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Leukocytes : (n=48, 46, 44, 52, 50) | 3 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Absolute Lymphocyte: (n=48, 46, 44, 52, 50) | 16 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Platelets: (n=48, 46, 43, 52, 50) | 2 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase | Low Absolute Neutrophils : (n=48, 46, 44, 52, 50) | 1 participants |
Secondary
Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase
ULN= upper limit of normal; Normal ranges are provided by the central laboratory and may vary according to sex and age. High alkaline phosphatase (ALP): \>5.0\*ULN U/L; High alanine aminotransferase (ALT): \>5.0\*ULN U/L; High aspartate aminotransferase (AST): \>5.0\*ULN U/L; High direct bilirubin: \>3.0 \* ULN mg/dL; High g-glutamyl transferase (GGT): \>5.0\*ULN U/L; High total bilirubin: \>3.0\*ULN mg/dL; High creatinine: \> 3.0\*ULN mg/dL
Time frame: Baseline (pretransplant), 4, 12, 24, 52 weeks
Population: ITT population, all randomized and transplanted participants. n= participants with all observations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Total Bilirubin: (n=48, 47, 44, 53, 50) | 9 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Creatinine: (n=47, 44, 44, 53, 50) | 0 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High GGT: (n=48, 47, 44, 53, 50) | 25 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High ALT: (n=48, 47, 44, 53, 50) | 16 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Direct Bilirubin: (n=48, 47, 44, 53, 50) | 15 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High AST: (n=48, 47, 44, 53, 50) | 9 participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High ALP: (n=48, 47, 44, 53, 50) | 5 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High GGT: (n=48, 47, 44, 53, 50) | 24 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High ALP: (n=48, 47, 44, 53, 50) | 6 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High AST: (n=48, 47, 44, 53, 50) | 14 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Total Bilirubin: (n=48, 47, 44, 53, 50) | 13 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Direct Bilirubin: (n=48, 47, 44, 53, 50) | 18 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High ALT: (n=48, 47, 44, 53, 50) | 18 participants |
| Group 2: Belatacept (MI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Creatinine: (n=47, 44, 44, 53, 50) | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Direct Bilirubin: (n=48, 47, 44, 53, 50) | 19 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Total Bilirubin: (n=48, 47, 44, 53, 50) | 16 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Creatinine: (n=47, 44, 44, 53, 50) | 0 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High ALP: (n=48, 47, 44, 53, 50) | 6 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High GGT: (n=48, 47, 44, 53, 50) | 24 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High ALT: (n=48, 47, 44, 53, 50) | 19 participants |
| Group 3: Belatacept (LI) + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High AST: (n=48, 47, 44, 53, 50) | 16 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Direct Bilirubin: (n=48, 47, 44, 53, 50) | 20 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High ALT: (n=48, 47, 44, 53, 50) | 16 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High GGT: (n=48, 47, 44, 53, 50) | 27 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Total Bilirubin: (n=48, 47, 44, 53, 50) | 12 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Creatinine: (n=47, 44, 44, 53, 50) | 0 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High ALP: (n=48, 47, 44, 53, 50) | 4 participants |
| Group 4: Tacrolimus + MMF | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High AST: (n=48, 47, 44, 53, 50) | 8 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Creatinine: (n=47, 44, 44, 53, 50) | 0 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High ALT: (n=48, 47, 44, 53, 50) | 9 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High AST: (n=48, 47, 44, 53, 50) | 2 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Total Bilirubin: (n=48, 47, 44, 53, 50) | 10 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High GGT: (n=48, 47, 44, 53, 50) | 22 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High Direct Bilirubin: (n=48, 47, 44, 53, 50) | 16 participants |
| Group 5: Tacrolimus | Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase | High ALP: (n=48, 47, 44, 53, 50) | 6 participants |
Secondary
Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase
Percentage of participants at any given time (at Month 6 and Month 12) who met the definition of dyslipidemia.Dyslipidemia is defined as hypertriglyceridemia (TGs ≥ 500 mg/dL \[5.65 mmol/L\]), hypercholesterolemia (LDL ≥ 100 mg/dL \[2.59 mmol/L\]), or elevated non-HDL (non-HDL ≥ 130 mg/dL \[3.36 mmol/L\]) in the presence of high TGs (TGs ≥ 200 mg/dL \[2.26 mmol/L\]).
Time frame: 6 and 12 months posttransplant
Population: ITT population, all randomized and transplanted participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Dyslipidemia | 36.0 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Hypertriglyceridemia | 6.0 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Hypercholesterolemia | 30.0 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Dyslipidemia | 40.0 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Hypertriglyceridemia | 4.0 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Hypercholesterolemia | 30.0 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Dyslipidemia | 33.3 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Hypertriglyceridemia | 0 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Hypertriglyceridemia | 0 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Hypercholesterolemia | 29.2 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Hypercholesterolemia | 29.2 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Dyslipidemia | 31.3 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Hypertriglyceridemia | 2.0 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Dyslipidemia | 30.6 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Hypercholesterolemia | 24.5 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Hypertriglyceridemia | 0 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Hypercholesterolemia | 40.8 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Dyslipidemia | 44.9 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Hypercholesterolemia | 30.2 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Dyslipidemia | 32.1 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Hypertriglyceridemia | 0 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Hypercholesterolemia | 30.2 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Dyslipidemia | 34.0 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Hypertriglyceridemia | 1.9 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Hypercholesterolemia | 36.0 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Hypertriglyceridemia | 2.0 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Hypercholesterolemia | 22.0 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Hypertriglyceridemia | 0 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 6 months: Dyslipidemia | 26.0 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase | 12 months: Dyslipidemia | 42.0 percentage of participants |
Secondary
Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase
For 95% CI within each group, normal approximation was used if N\>=5. Otherwise exact method was used.
Time frame: At 6 and 12 months
Population: ITT population: all randomized and transplanted participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase | At 6 months | 90.0 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase | At 12 months | 90.0 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase | At 6 months | 89.6 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase | At 12 months | 83.3 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase | At 6 months | 77.6 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase | At 12 months | 67.3 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase | At 12 months | 92.5 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase | At 6 months | 92.5 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase | At 6 months | 90.0 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase | At 12 months | 88.0 percentage of participants |
Comparison: Analysis at Month 695% CI: [-12.9, 8.7]
Comparison: Analysis at Month 695% CI: [-13.6, 8.5]
Comparison: Analysis at Month 695% CI: [-23.8, 1.5]
Comparison: Analysis at Month 6
Comparison: Analysis at Month 695% CI: [-12.1, 11.3]
Comparison: Analysis at Month 695% CI: [-22.9, 4.1]
Comparison: Analysis at Month 1295% CI: [-12.9, 8.7]
Comparison: Analysis at Month 1295% CI: [-18.1, 5.4]
Comparison: Analysis at Month 1295% CI: [-38.9, -9.5]
Comparison: Analysis at Month 1295% CI: [-9.9, 14.4]
Comparison: Analysis at Month 1295% CI: [-15.5, 10.7]
Comparison: Analysis at Month 1295% CI: [-35.5, -4.1]
Secondary
Percentage of Participants Surviving With Functional Graft by End of Study (Includes LTE Data)
For 95% CI within each group, normal approximation was used if N\>=5, otherwise exact method was used.
Time frame: Day 1 (randomization) through database lock (20-June-2011)
Population: ITT-LTE population, all randomized and transplanted participants who entered long term extension.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Surviving With Functional Graft by End of Study (Includes LTE Data) | 93.3 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Surviving With Functional Graft by End of Study (Includes LTE Data) | 85.2 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Surviving With Functional Graft by End of Study (Includes LTE Data) | 95.8 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Surviving With Functional Graft by End of Study (Includes LTE Data) | 92.1 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Surviving With Functional Graft by End of Study (Includes LTE Data) | 96.2 percentage of participants |
95% CI: [-14.5, 15.3]
95% CI: [-25.7, 8.8]
95% CI: [-13.2, 17.5]
95% CI: [-18.1, 13.1]
95% CI: [-29.4, 6.2]
95% CI: [-16.9, 15.3]
Secondary
Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase
Percentage of participants who develop dyslipidemia, defined as hypertriglyceridemia (triglycerides \[TGs\] ≥ 500 mg/dL \[5.65 mmol/L\]), hypercholesterolemia (Low density lipoprotein \[LDL\] ≥ 100 mg/dL \[2.59 mmol/L\]), or elevated non-high density lipoprotein (non- high density lipoprotein \[HDL\] ≥ 130 mg/dL \[3.36 mmol/L\]) in the presence of high TGs (TGs ≥ 200 mg/dL \[2.26 mmol/L\]).
Time frame: 6 and 12 months posttransplant
Population: ITT population, all randomized and transplanted participants who did not have dyslipidemia at baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Dyslipidemia | 50.0 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Hypertriglyceridemia | 2.4 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Hypercholesterolemia | 42.9 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Dyslipidemia | 59.5 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Hypertriglyceridemia | 4.8 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Hypercholesterolemia | 54.8 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Hypertriglyceridemia | 0 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Hypercholesterolemia | 54.3 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Dyslipidemia | 54.3 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Hypercholesterolemia | 48.6 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Dyslipidemia | 57.1 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Hypertriglyceridemia | 0 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Dyslipidemia | 58.7 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Hypertriglyceridemia | 2.2 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Dyslipidemia | 45.7 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Hypercholesterolemia | 39.1 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Hypertriglyceridemia | 0 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Hypercholesterolemia | 52.2 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Dyslipidemia | 50.0 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Hypertriglyceridemia | 0 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Hypercholesterolemia | 28.6 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Hypercholesterolemia | 42.9 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Hypertriglyceridemia | 2.4 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Dyslipidemia | 33.3 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Hypertriglyceridemia | 0 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Hypercholesterolemia | 51.4 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Hypertriglyceridemia | 0 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Hypercholesterolemia | 62.2 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 12 month: Dyslipidemia | 70.3 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase | By 6 month: Dyslipidemia | 59.5 percentage of participants |
Secondary
Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase
Percentage of participants who develop hypertension after randomization and transplantation. Transient post-operative increases in BP were not to be counted as new onset hypertension. Hypertension was to be assessed only at or after the Week 4 visit. Participants were considered to have hypertension when either of the following criteria were met: (1) SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg or (2) participant received an antihypertensive medication(s) for the indication of hypertension or due to medical history of hypertension.
Time frame: 6 and 12 months posttransplant
Population: ITT population, all randomized and transplanted participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase | By 6 months | 94.1 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase | By 12 months | 100 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase | By 6 months | 93.3 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase | By 12 months | 93.3 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase | By 6 months | 93.8 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase | By 12 months | 93.8 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase | By 12 months | 100.0 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase | By 6 months | 100.0 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase | By 6 months | 100 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase | By 12 months | 100.0 percentage of participants |
Comparison: Analysis at Month 695% CI: [-21.2, 6]
Comparison: Analysis at Month 695% CI: [-18.2, 5.3]
Comparison: Analysis at Month 695% CI: [-14.9, 4.5]
Comparison: Analysis at Month 695% CI: [-25.1, 7.1]
Comparison: Analysis at Month 695% CI: [-15.6, 4.5]
Comparison: Analysis at Month 695% CI: [-12.7, 3.9]
Comparison: Analysis at Month 12
Comparison: Analysis at Month 1295% CI: [-18.2, 5.3]
Comparison: Analysis at Month 1295% CI: [-14.9, 4.5]
Comparison: Analysis at Month 12
Comparison: Analysis at Month 1295% CI: [-15.6, 4.5]
Comparison: Analysis at Month 1295% CI: [-12.7, 3.9]
Secondary
Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by 12 Months
Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a blinded central histopathologist using Banff grading. Graft loss was defined as impairment of liver function to such a degree that the participant died or underwent re-transplantation. For 95% CI within each group, normal approximation is used if N\>=5. Otherwise exact method is used. For 95% CI of difference, adjustment is made for randomization strata if N \>= 5 in each treatment arm.
Time frame: At 12 months posttransplant
Population: ITT population: all randomized and transplanted participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by 12 Months | 52.0 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by 12 Months | 47.9 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by 12 Months | 53.1 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by 12 Months | 18.9 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by 12 Months | 40.0 percentage of participants |
95% CI: [15.8, 50.6]
95% CI: [11.4, 46.3]
95% CI: [16.9, 51.5]
95% CI: [-7.1, 31.6]
95% CI: [-11.5, 27.2]
95% CI: [-5.9, 32.6]
Secondary
Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by End of Study (Includes LTE Data)
Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a central histopathologist using Banff criteria. For 95% CI within each group, normal approximation was used if N\>=5, otherwise exact method was used.
Time frame: Day 1 (randomization) through database lock (20-June-2011)
Population: ITT-LTE population: all randomized and transplanted participants who entered the Long term extension
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by End of Study (Includes LTE Data) | 36.7 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by End of Study (Includes LTE Data) | 37.0 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by End of Study (Includes LTE Data) | 25.0 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by End of Study (Includes LTE Data) | 21.1 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by End of Study (Includes LTE Data) | 23.1 percentage of participants |
95% CI: [-5.8, 36.8]
95% CI: [-6, 38]
95% CI: [-16.6, 26.8]
95% CI: [-10.8, 36.1]
95% CI: [-10.9, 37.3]
95% CI: [-21.8, 26]
Secondary
Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase
Percentage of participants at any given time who meet the definition of hypertension. Participants were considered to have hypertension when either of the following criteria were met: (1) SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg or (2) participant received an antihypertensive medication(s) for the indication of hypertension or due to medical history of hypertension.
Time frame: 6 and 12 months posttransplant
Population: ITT population, all randomized and transplanted participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase | By 6 months | 64.0 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase | By 12 months | 72.0 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase | By 6 months | 77.1 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase | By 12 months | 68.8 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase | By 6 months | 69.4 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase | By 12 months | 59.2 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase | By 12 months | 79.2 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase | By 6 months | 71.7 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase | By 6 months | 70.0 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase | By 12 months | 70.0 percentage of participants |
Comparison: Analysis at Month 695% CI: [-25.6, 10.2]
Comparison: Analysis at Month 695% CI: [-11.7, 22.3]
Comparison: Analysis at Month 695% CI: [-20.1, 15.2]
Comparison: Analysis at Month 1295% CI: [-24, 12.5]
Comparison: Analysis at Month 695% CI: [-10.5, 24.2]
Comparison: Analysis at Month 695% CI: [-18.5, 17.6]
Comparison: Analysis at Month 1295% CI: [-23.3, 9.4]
Comparison: Analysis at Month 1295% CI: [-27.4, 6.5]
Comparison: Analysis at Month 1295% CI: [-37.5, -2.7]
Comparison: Analysis at Month 1295% CI: [-15.5, 19.7]
Comparison: Analysis at Month 1295% CI: [-19.4, 16.9]
Comparison: Analysis at Month 1295% CI: [-29.3, 7.9]
Secondary
Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months
HCV Recurrence is defined as Histological confirmation on liver biopsy by the Ishak (modified Knodell) system and required both a score \>= 5 out of 18 on modified Histological Activity Index grading and a fibrosis Score \>= 2 out of 6 on modified staging. All biopsies, including Week 52 biopsies, were considered. Only the first HCV recurrence episode for each participant was counted. For 95% CI within each group, normal approximation was used if N\>=5, otherwise exact method was used. For 95% CI of difference, normal approximation was used if N\>=5 in both arms, otherwise exact method was used.
Time frame: 6 and 12 months posttransplant
Population: ITT population, all randomized and transplanted participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months | 12 months | 60.9 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months | 6 months | 39.1 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months | 12 months | 30.4 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months | 6 months | 21.7 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months | 12 months | 28.6 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months | 6 months | 23.8 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months | 6 months | 20.0 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months | 12 months | 52.0 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months | 12 months | 37.5 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months | 6 months | 33.3 percentage of participants |
Comparison: Analysis at Month 695% CI: [-6.7, 43.3]
Comparison: Analysis at Month 695% CI: [-21.6, 25.5]
Comparison: Analysis at Month 695% CI: [-20.1, 28.7]
Comparison: Analysis at Month 695% CI: [-21.2, 32.1]
Comparison: Analysis at Month 695% CI: [-36, 14.2]
Comparison: Analysis at Month 695% CI: [-34.6, 17.3]
Comparison: Analysis at Month 1295% CI: [-18.8, 35.1]
Comparison: Analysis at Month 1295% CI: [-46.3, 6.3]
Comparison: Analysis at Month 1295% CI: [-48.2, 5.2]
Comparison: Analysis at Month 1295% CI: [-5.2, 48.4]
Comparison: Analysis at Month 1295% CI: [-32.9, 19.8]
Comparison: Analysis at Month 1295% CI: [-34.8, 18.7]
Secondary
Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE
HCV Recurrence is defined as Histological confirmation on liver biopsy by the Ishak (modified Knodell) system and required both a score \>= 5 out of 18 on modified Histological Activity Index grading and a fibrosis Score \>= 2 out of 6 on modified staging. All biopsies, including Week 52 biopsies, were considered. Only the first HCV recurrence episode for each participant was counted. For 95% CI within each group, normal approximation was used if N\>=5, otherwise exact method was used. For 95% CI of difference, normal approximation was used if N\>=5 in both arms, otherwise exact method was used.
Time frame: 12 months posttransplant, end of study (database lock, 20-June-2011)
Population: ITT-LTE population, all randomized and transplanted participants who entered long-term extension.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE | At 12 months | 50.0 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE | At end of study | 66.7 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE | At end of study | 50.0 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE | At 12 months | 41.7 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE | At 12 months | 0 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE | At end of study | 22.2 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE | At 12 months | 58.8 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE | At end of study | 64.7 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE | At end of study | 72.7 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE | At 12 months | 72.7 percentage of participants |
Comparison: Analysis at Month 1295% CI: [-42.4, 26.3]
Comparison: Analysis at Month 1295% CI: [-49.2, 19]
Comparison: Analysis at Month 1295% CI: [-81.6, -19.8]
Comparison: Analysis at Month 1295% CI: [-55.9, 16.9]
Comparison: Analysis at Month 1295% CI: [-62.6, 9.4]
Comparison: Analysis at Month 1295% CI: [-94, -33.1]
Comparison: Analysis at database lock95% CI: [-32.6, 34.3]
Comparison: Analysis at database lock95% CI: [-47.4, 20.6]
Comparison: Analysis at database lock95% CI: [-72.6, 0.5]
Comparison: Analysis at database lock95% CI: [-41.1, 31.1]
Comparison: Analysis at database lock95% CI: [-55.9, 16.9]
Comparison: Analysis at database lock95% CI: [-81.9, -3.5]
Secondary
Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase
A participant who did not have diabetes prior to randomization was determined to have NODM if(i) the participant received an antidiabetic medication for a duration of at least 30 days or(ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is\>=126 mg/dL (7.0 mmol/L). For 95% CI within each group, normal approximation is used if N\>=5. For 95% CI of difference, adjustment is made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm.
Time frame: 6 and 12 months posttransplant
Population: ITT population, all randomized participants without Diabetes Mellitus (pre-transplantation).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase | 6 months | 35.5 percentage of participants |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase | 12 months | 35.5 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase | 6 months | 15.6 percentage of participants |
| Group 2: Belatacept (MI) + MMF | Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase | 12 months | 15.6 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase | 6 months | 13.9 percentage of participants |
| Group 3: Belatacept (LI) + MMF | Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase | 12 months | 13.9 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase | 12 months | 23.7 percentage of participants |
| Group 4: Tacrolimus + MMF | Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase | 6 months | 21.1 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase | 6 months | 35.1 percentage of participants |
| Group 5: Tacrolimus | Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase | 12 months | 37.8 percentage of participants |
Comparison: Analysis at Month 695% CI: [-6.3, 36]
Comparison: Analysis at Month 695% CI: [-23.4, 10.2]
Comparison: Analysis at Month 695% CI: [-23.4, 10]
Comparison: Analysis at Month 695% CI: [-22, 23.4]
Comparison: Analysis at Month 695% CI: [-38.6, -0.1]
Comparison: Analysis at Month 695% CI: [-39.1, -1.8]
Comparison: Analysis at Month 1295% CI: [-8.7, 34]
Comparison: Analysis at Month 1295% CI: [-25.2, 8.7]
Comparison: Analysis at Month 1295% CI: [-26.3, 7.7]
Comparison: Analysis at Month 12.95% CI: [-24.5, 21.1]
Comparison: Analysis at Month 1295% CI: [-40.5, -1.9]
Comparison: Analysis at Month 1295% CI: [-41.8, -4.3]
Secondary
Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase
Participants were considered to have hypertension if they had Diastolic Blood Pressure (SBP) ≥ 80 mmHg.
Time frame: BL (pretransplant), 1, 3, 6, 9, 12 months posttransplant
Population: ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 74.4 mm Hg | Standard Deviation 10.34 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 74.4 mm Hg | Standard Deviation 10.63 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 64.5 mm Hg | Standard Deviation 12.86 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 10.0 mm Hg | Standard Deviation 14.41 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 42) | 77.4 mm Hg | Standard Deviation 9.57 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 8.8 mm Hg | Standard Deviation 15.49 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 76.5 mm Hg | Standard Deviation 9.38 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 10.0 mm Hg | Standard Deviation 14.53 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 75.4 mm Hg | Standard Deviation 9.96 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 11.5 mm Hg | Standard Deviation 14.32 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 10.26 mm Hg | Standard Deviation 15.71 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 15.2 mm Hg | Standard Deviation 11.9 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 17.0 mm Hg | Standard Deviation 12.86 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 79.4 mm Hg | Standard Deviation 10.17 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 74.7 mm Hg | Standard Deviation 9.51 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 78.5 mm Hg | Standard Deviation 11.43 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 11.7 mm Hg | Standard Deviation 12.48 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 63.1 mm Hg | Standard Deviation 11.5 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 15.2 mm Hg | Standard Deviation 16.91 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 42) | 78.3 mm Hg | Standard Deviation 10.85 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 16.3 mm Hg | Standard Deviation 15.28 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 78.5 mm Hg | Standard Deviation 11.45 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 9.7 mm Hg | Standard Deviation 16.27 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 72.6 mm Hg | Standard Deviation 13.84 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 62.9 mm Hg | Standard Deviation 10.54 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 42) | 76.1 mm Hg | Standard Deviation 10.81 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 12.0 mm Hg | Standard Deviation 15.7 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 76.3 mm Hg | Standard Deviation 9.69 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 12.5 mm Hg | Standard Deviation 14.93 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 77.6 mm Hg | Standard Deviation 9.1 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 13.2 mm Hg | Standard Deviation 14.54 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 74.5 mm Hg | Standard Deviation 8.54 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 10.6 mm Hg | Standard Deviation 14.35 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 42) | 81.7 mm Hg | Standard Deviation 10.94 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 67.5 mm Hg | Standard Deviation 12.55 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 77.8 mm Hg | Standard Deviation 10.26 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 10.21 mm Hg | Standard Deviation 13.6 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 80.3 mm Hg | Standard Deviation 10.21 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 10.7 mm Hg | Standard Deviation 13.8 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 77.8 mm Hg | Standard Deviation 12.68 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 79.5 mm Hg | Standard Deviation 10.74 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 11.2 mm Hg | Standard Deviation 15.37 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 14.4 mm Hg | Standard Deviation 15.27 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 10.7 mm Hg | Standard Deviation 14.44 |
| Group 5: Tacrolimus | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 68.6 mm Hg | Standard Deviation 12.07 |
| Group 5: Tacrolimus | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 8.6 mm Hg | Standard Deviation 14.58 |
| Group 5: Tacrolimus | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 42) | 78.2 mm Hg | Standard Deviation 9.86 |
| Group 5: Tacrolimus | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 79.5 mm Hg | Standard Deviation 10.15 |
| Group 5: Tacrolimus | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 5.8 mm Hg | Standard Deviation 14.05 |
| Group 5: Tacrolimus | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 10.8 mm Hg | Standard Deviation 13.2 |
| Group 5: Tacrolimus | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 11.2 mm Hg | Standard Deviation 13.25 |
| Group 5: Tacrolimus | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 74.6 mm Hg | Standard Deviation 10.76 |
| Group 5: Tacrolimus | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 79.5 mm Hg | Standard Deviation 11.24 |
| Group 5: Tacrolimus | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 76.6 mm Hg | Standard Deviation 9.11 |
| Group 5: Tacrolimus | Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 9.9 mm Hg | Standard Deviation 15.35 |
Secondary
Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase
Time frame: Baseline (pretransplant), 1, 6, 12 months posttransplant
Population: ITT population, all randomized and transplanted participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | BL (n=45, 42, 44, 49, 47) | 112.9 mg/dL | Standard Deviation 49.76 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 12 months (n=35, 29,32, 42, 34) | 79.4 mg/dL | Standard Deviation 86.88 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 186.8 mg/dL | Standard Deviation 87.16 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 1 month (n=42, 41, 39, 45, 46) | 57.0 mg/dL | Standard Deviation 63.06 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 1 month (n=46, 47, 42, 49, 49) | 166.3 mg/dL | Standard Deviation 45.92 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 180.8 mg/dL | Standard Deviation 52.76 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=35, 30, 35, 44, 33) | 68.6 mg/dL | Standard Deviation 60.07 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=35, 30, 35, 44, 33) | 51.3 mg/dL | Standard Deviation 63.22 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 177.3 mg/dL | Standard Deviation 49.56 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 1 month (n=46, 47, 42, 49, 49) | 184.9 mg/dL | Standard Deviation 77.16 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | BL (n=45, 42, 44, 49, 47) | 119.7 mg/dL | Standard Deviation 51.81 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 178.9 mg/dL | Standard Deviation 42.13 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 1 month (n=42, 41, 39, 45, 46) | 67.7 mg/dL | Standard Deviation 102.3 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 12 months (n=35, 29,32, 42, 34) | 57.5 mg/dL | Standard Deviation 73.67 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 182.2 mg/dL | Standard Deviation 45.58 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | BL (n=45, 42, 44, 49, 47) | 121.3 mg/dL | Standard Deviation 63.05 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 1 month (n=46, 47, 42, 49, 49) | 190.6 mg/dL | Standard Deviation 69.54 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 1 month (n=42, 41, 39, 45, 46) | 61.3 mg/dL | Standard Deviation 84.2 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=35, 30, 35, 44, 33) | 56.6 mg/dL | Standard Deviation 72.89 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 186.4 mg/dL | Standard Deviation 59.11 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 12 months (n=35, 29,32, 42, 34) | 60.7 mg/dL | Standard Deviation 92.87 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 1 month (n=42, 41, 39, 45, 46) | 54.0 mg/dL | Standard Deviation 70.01 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=35, 30, 35, 44, 33) | 58.9 mg/dL | Standard Deviation 66.3 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 1 month (n=46, 47, 42, 49, 49) | 162.9 mg/dL | Standard Deviation 43.72 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 12 months (n=35, 29,32, 42, 34) | 58.2 mg/dL | Standard Deviation 64.05 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 163.8 mg/dL | Standard Deviation 46.41 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | BL (n=45, 42, 44, 49, 47) | 111.0 mg/dL | Standard Deviation 54.91 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 170.6 mg/dL | Standard Deviation 49.3 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 1 month (n=42, 41, 39, 45, 46) | 53.4 mg/dL | Standard Deviation 57.19 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 12 months (n=35, 29,32, 42, 34) | 57.3 mg/dL | Standard Deviation 72.22 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 175.2 mg/dL | Standard Deviation 38.37 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=35, 30, 35, 44, 33) | 60.8 mg/dL | Standard Deviation 71.33 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 1 month (n=46, 47, 42, 49, 49) | 164.1 mg/dL | Standard Deviation 52.95 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | BL (n=45, 42, 44, 49, 47) | 106.4 mg/dL | Standard Deviation 51.82 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 177.9 mg/dL | Standard Deviation 57.92 |
Secondary
Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase
Time frame: Baseline (pretransplant), 1, 6, 12 months posttransplant
Population: ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 41.5 mg/dL | Standard Deviation 14.29 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=36, 30, 35, 44, 32) | 9.2 mg/dL | Standard Deviation 21.56 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to12 months (n=36, 29, 32, 42, 33) | 12.7 mg/dL | Standard Deviation 23.25 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 43.6 mg/dL | Standard Deviation 14.4 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to 1month (n=43, 41, 39, 45, 45) | 9.9 mg/dL | Standard Deviation 26.83 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 1 month (n=46, 47, 42, 49, 49) | 41.3 mg/dL | Standard Deviation 15.37 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | BL (n=46, 42, 44, 49, 46) | 32.1 mg/dL | Standard Deviation 17.38 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 1 month (n=46, 47, 42, 49, 49) | 36.9 mg/dL | Standard Deviation 17.8 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 42.8 mg/dL | Standard Deviation 14.17 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to12 months (n=36, 29, 32, 42, 33) | 8.3 mg/dL | Standard Deviation 22.75 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=36, 30, 35, 44, 32) | 7.3 mg/dL | Standard Deviation 20.4 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | BL (n=46, 42, 44, 49, 46) | 36.2 mg/dL | Standard Deviation 17.49 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 41.5 mg/dL | Standard Deviation 15.19 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to 1month (n=43, 41, 39, 45, 45) | 1.7 mg/dL | Standard Deviation 26.15 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 44.2 mg/dL | Standard Deviation 14.56 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | BL (n=46, 42, 44, 49, 46) | 36.5 mg/dL | Standard Deviation 19.66 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 1 month (n=46, 47, 42, 49, 49) | 42.5 mg/dL | Standard Deviation 19.6 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to 1month (n=43, 41, 39, 45, 45) | 7.2 mg/dL | Standard Deviation 27.72 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=36, 30, 35, 44, 32) | 9.4 mg/dL | Standard Deviation 22.06 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 44.2 mg/dL | Standard Deviation 14.37 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to12 months (n=36, 29, 32, 42, 33) | 7.3 mg/dL | Standard Deviation 24.71 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to 1month (n=43, 41, 39, 45, 45) | 7.1 mg/dL | Standard Deviation 22.65 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=36, 30, 35, 44, 32) | 10.8 mg/dL | Standard Deviation 28.26 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 1 month (n=46, 47, 42, 49, 49) | 41.2 mg/dL | Standard Deviation 11.32 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to12 months (n=36, 29, 32, 42, 33) | 10.9 mg/dL | Standard Deviation 24.13 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 45.6 mg/dL | Standard Deviation 15.35 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | BL (n=46, 42, 44, 49, 46) | 33.3 mg/dL | Standard Deviation 21.97 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 45.5 mg/dL | Standard Deviation 15.8 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to 1month (n=43, 41, 39, 45, 45) | 3.4 mg/dL | Standard Deviation 21.37 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to12 months (n=36, 29, 32, 42, 33) | 10.0 mg/dL | Standard Deviation 21.01 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 43.3 mg/dL | Standard Deviation 15.58 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=36, 30, 35, 44, 32) | 9.5 mg/dL | Standard Deviation 24.32 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 1 month (n=46, 47, 42, 49, 49) | 34.1 mg/dL | Standard Deviation 14.11 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | BL (n=46, 42, 44, 49, 46) | 31.1 mg/dL | Standard Deviation 15.5 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 42.6 mg/dL | Standard Deviation 17.92 |
Secondary
Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase
Time frame: Baseline (pretransplant), 1, 6, 12 months posttransplant
Population: ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 6 months (n=16, 19, 18, 28, 22) | 41.2 mg/dL | Standard Deviation 33.82 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 6 months (n=27, 29, 27, 41, 30) | 99.2 mg/dL | Standard Deviation 36.93 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 12 months (n=22, 19, 20, 25, 22) | 37.8 mg/dL | Standard Deviation 33.09 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 12 months (n=38, 29, 32, 42, 35) | 93.0 mg/dL | Standard Deviation 30.72 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 1 month (n=17, 21, 17, 27, 30) | 42.7 mg/dL | Standard Deviation 47.94 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 1 month (n=30, 34, 29, 41, 42) | 95.2 mg/dL | Standard Deviation 33.82 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | BL (n=29, 30, 25, 34, 32) | 52.3 mg/dL | Standard Deviation 25.26 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 1 month (n=30, 34, 29, 41, 42) | 93.2 mg/dL | Standard Deviation 33.73 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 6 months (n=27, 29, 27, 41, 30) | 107.5 mg/dL | Standard Deviation 36.93 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 12 months (n=22, 19, 20, 25, 22) | 45.4 mg/dL | Standard Deviation 51.75 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 6 months (n=16, 19, 18, 28, 22) | 45.9 mg/dL | Standard Deviation 42.13 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | BL (n=29, 30, 25, 34, 32) | 58.6 mg/dL | Standard Deviation 34.97 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 12 months (n=38, 29, 32, 42, 35) | 107.2 mg/dL | Standard Deviation 32.75 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 1 month (n=17, 21, 17, 27, 30) | 34.3 mg/dL | Standard Deviation 48.98 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 6 months (n=27, 29, 27, 41, 30) | 98.2 mg/dL | Standard Deviation 42.85 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | BL (n=29, 30, 25, 34, 32) | 58.9 mg/dL | Standard Deviation 34.08 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 1 month (n=30, 34, 29, 41, 42) | 115.7 mg/dL | Standard Deviation 58.88 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 1 month (n=17, 21, 17, 27, 30) | 57.1 mg/dL | Standard Deviation 30.19 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 6 months (n=16, 19, 18, 28, 22) | 48.7 mg/dL | Standard Deviation 41.66 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 12 months (n=38, 29, 32, 42, 35) | 103.2 mg/dL | Standard Deviation 36.41 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 12 months (n=22, 19, 20, 25, 22) | 37.2 mg/dL | Standard Deviation 47.81 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 1 month (n=17, 21, 17, 27, 30) | 26.1 mg/dL | Standard Deviation 48.4 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 6 months (n=16, 19, 18, 28, 22) | 28.9 mg/dL | Standard Deviation 49.29 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 1 month (n=30, 34, 29, 41, 42) | 89.8 mg/dL | Standard Deviation 37.31 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 12 months (n=22, 19, 20, 25, 22) | 23.7 mg/dL | Standard Deviation 46.8 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 12 months (n=38, 29, 32, 42, 35) | 89.0 mg/dL | Standard Deviation 37.15 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | BL (n=29, 30, 25, 34, 32) | 63.6 mg/dL | Standard Deviation 45.02 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 6 months (n=27, 29, 27, 41, 30) | 96.7 mg/dL | Standard Deviation 42.22 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 1 month (n=17, 21, 17, 27, 30) | 41.5 mg/dL | Standard Deviation 43.68 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 12 months (n=22, 19, 20, 25, 22) | 13.7 mg/dL | Standard Deviation 50.98 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 12 months (n=38, 29, 32, 42, 35) | 93.8 mg/dL | Standard Deviation 27.45 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | Change from BL to 6 months (n=16, 19, 18, 28, 22) | 26.1 mg/dL | Standard Deviation 54.04 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 1 month (n=30, 34, 29, 41, 42) | 98.4 mg/dL | Standard Deviation 47.68 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | BL (n=29, 30, 25, 34, 32) | 59.9 mg/dL | Standard Deviation 42.6 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase | 6 months (n=27, 29, 27, 41, 30) | 92.8 mg/dL | Standard Deviation 29.03 |
Secondary
Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase
Time frame: Baseline (pretransplant), 1, 6, 12 months posttransplant
Population: ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | BL (n=45, 42, 44, 49, 46) | 80.4 mg/dL | Standard Deviation 37.1 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 12 months (n=35, 29, 32, 42, 33) | 66.7 mg/dL | Standard Deviation 80.64 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 143.2 mg/dL | Standard Deviation 84.77 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 1 months (n=42, 41, 39, 45, 45) | 47.2 mg/dL | Standard Deviation 50.14 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 1 months (n=46, 47, 42, 49, 49) | 125.1 mg/dL | Standard Deviation 42.91 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 139.3 mg/dL | Standard Deviation 48.93 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=35, 30, 35, 44, 32) | 59.5 mg/dL | Standard Deviation 48.06 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=35, 30, 35, 44, 32) | 44.0 mg/dL | Standard Deviation 54.37 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 134.4 mg/dL | Standard Deviation 45.16 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 1 months (n=46, 47, 42, 49, 49) | 147.9 mg/dL | Standard Deviation 82.96 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | BL (n=45, 42, 44, 49, 46) | 83.5 mg/dL | Standard Deviation 44.2 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 137.4 mg/dL | Standard Deviation 38.49 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 1 months (n=42, 41, 39, 45, 45) | 66.0 mg/dL | Standard Deviation 102 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 12 months (n=35, 29, 32, 42, 33) | 49.2 mg/dL | Standard Deviation 63.87 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 138.9 mg/dL | Standard Deviation 43.39 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | BL (n=45, 42, 44, 49, 46) | 84.8 mg/dL | Standard Deviation 60.76 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 1 months (n=46, 47, 42, 49, 49) | 148.0 mg/dL | Standard Deviation 71.11 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 1 months (n=42, 41, 39, 45, 45) | 54.1 mg/dL | Standard Deviation 86.63 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=35, 30, 35, 44, 32) | 48.2 mg/dL | Standard Deviation 75.74 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 142.2 mg/dL | Standard Deviation 62.41 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 12 months (n=35, 29, 32, 42, 33) | 53.4 mg/dL | Standard Deviation 97.28 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 1 months (n=42, 41, 39, 45, 45) | 47.0 mg/dL | Standard Deviation 61.36 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=35, 30, 35, 44, 32) | 48.1 mg/dL | Standard Deviation 51.09 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 1 months (n=46, 47, 42, 49, 49) | 121.7 mg/dL | Standard Deviation 40.25 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 12 months (n=35, 29, 32, 42, 33) | 47.4 mg/dL | Standard Deviation 54.8 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 118.2 mg/dL | Standard Deviation 43 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | BL (n=45, 42, 44, 49, 46) | 77.7 mg/dL | Standard Deviation 44.3 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 125.1 mg/dL | Standard Deviation 44.02 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 1 months (n=42, 41, 39, 45, 45) | 47.5 mg/dL | Standard Deviation 50.32 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 12 months (n=35, 29, 32, 42, 33) | 44.1 mg/dL | Standard Deviation 72.35 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 12 months (n=40, 33, 35, 45, 37) | 131.9 mg/dL | Standard Deviation 39.71 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | Change from BL to 6 months (n=35, 30, 35, 44, 32) | 48.6 mg/dL | Standard Deviation 76.78 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 1 months (n=46, 47, 42, 49, 49) | 130.0 mg/dL | Standard Deviation 50.75 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | BL (n=45, 42, 44, 49, 46) | 76.8 mg/dL | Standard Deviation 46.85 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase | 6 months (n=39, 34, 38, 48, 36) | 135.4 mg/dL | Standard Deviation 58.49 |
Secondary
Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase
Time frame: Baseline (pretransplant), 1, 6, 12 months posttransplant
Population: ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | BL (n=29, 30, 25, 34, 32) | 94.4 mg/dL | Standard Deviation 60.42 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 12 months (n=22, 19, 20, 25, 21) | 237.2 mg/dL | Standard Deviation 703.9 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 12 months (n=38, 29, 32, 42, 34) | 255.1 mg/dL | Standard Deviation 582.7 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 1 month (n=16, 20, 17, 27, 30) | 71.2 mg/dL | Standard Deviation 84.87 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 1 month (n=29, 33, 29, 41, 43) | 153.9 mg/dL | Standard Deviation 65.83 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 6 months (n=26, 29, 25, 41, 30) | 234.3 mg/dL | Standard Deviation 316.6 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 6 months (n=15, 19, 18, 28, 22) | 199.9 mg/dL | Standard Deviation 329.1 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 6 months (n=15, 19, 18, 28, 22) | 18.3 mg/dL | Standard Deviation 140.8 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 6 months (n=26, 29, 25, 41, 30) | 157.1 mg/dL | Standard Deviation 82.23 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 1 month (n=29, 33, 29, 41, 43) | 162.9 mg/dL | Standard Deviation 108.1 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | BL (n=29, 30, 25, 34, 32) | 110.1 mg/dL | Standard Deviation 135.1 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 12 months (n=38, 29, 32, 42, 34) | 159.0 mg/dL | Standard Deviation 70.77 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 1 month (n=16, 20, 17, 27, 30) | 45.7 mg/dL | Standard Deviation 223 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 12 months (n=22, 19, 20, 25, 21) | 20.3 mg/dL | Standard Deviation 180.9 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 6 months (n=26, 29, 25, 41, 30) | 162.7 mg/dL | Standard Deviation 109.2 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | BL (n=29, 30, 25, 34, 32) | 80.2 mg/dL | Standard Deviation 46.29 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 1 month (n=29, 33, 29, 41, 43) | 149.0 mg/dL | Standard Deviation 72.84 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 1 month (n=16, 20, 17, 27, 30) | 85.8 mg/dL | Standard Deviation 93.63 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 6 months (n=15, 19, 18, 28, 22) | 88.7 mg/dL | Standard Deviation 113.1 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 12 months (n=38, 29, 32, 42, 34) | 158.2 mg/dL | Standard Deviation 99.93 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 12 months (n=22, 19, 20, 25, 21) | 91.6 mg/dL | Standard Deviation 118 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 1 month (n=16, 20, 17, 27, 30) | 68.2 mg/dL | Standard Deviation 75.45 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 6 months (n=15, 19, 18, 28, 22) | 60.8 mg/dL | Standard Deviation 63.06 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 1 month (n=29, 33, 29, 41, 43) | 149.1 mg/dL | Standard Deviation 61.27 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 12 months (n=22, 19, 20, 25, 21) | 72.3 mg/dL | Standard Deviation 60.61 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 12 months (n=38, 29, 32, 42, 34) | 156.4 mg/dL | Standard Deviation 105.7 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | BL (n=29, 30, 25, 34, 32) | 84.4 mg/dL | Standard Deviation 34.22 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 6 months (n=26, 29, 25, 41, 30) | 148.1 mg/dL | Standard Deviation 67.5 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 1 month (n=16, 20, 17, 27, 30) | 71.8 mg/dL | Standard Deviation 58.66 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 12 months (n=22, 19, 20, 25, 21) | 92.6 mg/dL | Standard Deviation 116.4 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 12 months (n=38, 29, 32, 42, 34) | 190.5 mg/dL | Standard Deviation 125.7 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | Change from BL to 6 months (n=15, 19, 18, 28, 22) | 84.3 mg/dL | Standard Deviation 105.2 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 1 month (n=29, 33, 29, 41, 43) | 163.5 mg/dL | Standard Deviation 73.8 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | BL (n=29, 30, 25, 34, 32) | 89.2 mg/dL | Standard Deviation 73.45 |
| Group 5: Tacrolimus | Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase | 6 months (n=26, 29, 25, 41, 30) | 167.2 mg/dL | Standard Deviation 100.8 |
Secondary
Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase
Time frame: BL (pretransplant), 1, 3, 6, 9, 12 months posttransplant
Population: ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 11.3 mm Hg | Standard Deviation 15.4 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 9.3 mm Hg | Standard Deviation 14.58 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 10.1 mm Hg | Standard Deviation 15.41 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 41) | 93.9 mm Hg | Standard Deviation 9.78 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 93.0 mm Hg | Standard Deviation 8.61 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 10.1 mm Hg | Standard Deviation 15.06 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 92.1 mm Hg | Standard Deviation 10.41 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 90.7 mm Hg | Standard Deviation 10.97 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 81.4 mm Hg | Standard Deviation 12.98 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 8.7 mm Hg | Standard Deviation 15.71 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 91.0 mm Hg | Standard Deviation 10.7 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 94.6 mm Hg | Standard Deviation 11.9 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 80.5 mm Hg | Standard Deviation 13.58 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 91.9 mm Hg | Standard Deviation 10.44 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 11.4 mm Hg | Standard Deviation 14.96 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 41) | 94.5 mm Hg | Standard Deviation 11.14 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 14.0 mm Hg | Standard Deviation 14.21 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 95.1 mm Hg | Standard Deviation 10.92 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 14.4 mm Hg | Standard Deviation 15.63 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 94.3 mm Hg | Standard Deviation 10.22 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 13.1 mm Hg | Standard Deviation 19.9 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 14.3 mm Hg | Standard Deviation 18.11 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 13.2 mm Hg | Standard Deviation 13.82 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 79.1 mm Hg | Standard Deviation 10.32 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 9.6 mm Hg | Standard Deviation 16.75 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 41) | 92.2 mm Hg | Standard Deviation 12.18 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 88.7 mm Hg | Standard Deviation 14.09 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 90.1 mm Hg | Standard Deviation 8.89 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 12.6 mm Hg | Standard Deviation 14.35 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 12.2 mm Hg | Standard Deviation 15.95 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 10.6 mm Hg | Standard Deviation 13.06 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 93.0 mm Hg | Standard Deviation 8.68 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 92.4 mm Hg | Standard Deviation 9.94 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 14.3 mm Hg | Standard Deviation 17.12 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 12.3 mm Hg | Standard Deviation 17.71 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 95.4 mm Hg | Standard Deviation 15.04 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 85.4 mm Hg | Standard Deviation 12.97 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 10.0 mm Hg | Standard Deviation 13.86 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 15.1 mm Hg | Standard Deviation 17.11 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 10.5 mm Hg | Standard Deviation 17.18 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 99.2 mm Hg | Standard Deviation 11.56 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 95.0 mm Hg | Standard Deviation 9.89 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 41) | 100.1 mm Hg | Standard Deviation 12.29 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 98.2 mm Hg | Standard Deviation 12.46 |
| Group 5: Tacrolimus | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 41) | 96.5 mm Hg | Standard Deviation 9.01 |
| Group 5: Tacrolimus | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 9.6 mm Hg | Standard Deviation 15.59 |
| Group 5: Tacrolimus | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 99.0 mm Hg | Standard Deviation 12.13 |
| Group 5: Tacrolimus | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 95.0 mm Hg | Standard Deviation 11.7 |
| Group 5: Tacrolimus | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 12.1 mm Hg | Standard Deviation 15.76 |
| Group 5: Tacrolimus | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 8.5 mm Hg | Standard Deviation 16.74 |
| Group 5: Tacrolimus | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 87.5 mm Hg | Standard Deviation 13.42 |
| Group 5: Tacrolimus | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 97.7 mm Hg | Standard Deviation 10.34 |
| Group 5: Tacrolimus | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 11.3 mm Hg | Standard Deviation 13.25 |
| Group 5: Tacrolimus | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 4.1 mm Hg | Standard Deviation 15.76 |
| Group 5: Tacrolimus | Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 91.3 mm Hg | Standard Deviation 11.61 |
Secondary
Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase
Time frame: Baseline (pretransplant), 1, 3, 6, 9, 12 months posttransplant
Population: ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 8.4 mm Hg | Standard Deviation 23.18 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 124.0 mm Hg | Standard Deviation 16.09 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 125.8 mm Hg | Standard Deviation 12.79 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 115.3 mm Hg | Standard Deviation 18.41 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 42) | 127.0 mm Hg | Standard Deviation 15.04 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 123.3 mm Hg | Standard Deviation 16.87 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 9.2 mm Hg | Standard Deviation 22.96 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 10.4 mm Hg | Standard Deviation 21.36 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 8.0 mm Hg | Standard Deviation 19.95 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 10.9 mm Hg | Standard Deviation 23.1 |
| Group 1: Basiliximab+Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 125.5 mm Hg | Standard Deviation 16.24 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 10.9 mm Hg | Standard Deviation 27.03 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 9.3 mm Hg | Standard Deviation 24.44 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 126.5 mm Hg | Standard Deviation 15.87 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 126.3 mm Hg | Standard Deviation 15.44 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 115.4 mm Hg | Standard Deviation 22.35 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 127.0 mm Hg | Standard Deviation 17.02 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 11.7 mm Hg | Standard Deviation 23.85 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 10.2 mm Hg | Standard Deviation 27.33 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 8.8 mm Hg | Standard Deviation 29.71 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 42) | 126.9 mm Hg | Standard Deviation 15.03 |
| Group 2: Belatacept (MI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 125.8 mm Hg | Standard Deviation 13.16 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 121.2 mm Hg | Standard Deviation 13.06 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 111.4 mm Hg | Standard Deviation 15.8 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 120.9 mm Hg | Standard Deviation 16.96 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 9.4 mm Hg | Standard Deviation 21.65 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 42) | 124.4 mm Hg | Standard Deviation 17.65 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 12.7 mm Hg | Standard Deviation 21.3 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 124.6 mm Hg | Standard Deviation 14.75 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 12.8 mm Hg | Standard Deviation 19.77 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 123.9 mm Hg | Standard Deviation 12.22 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 13.3 mm Hg | Standard Deviation 21.94 |
| Group 3: Belatacept (LI) + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 10.6 mm Hg | Standard Deviation 17.46 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 16.3 mm Hg | Standard Deviation 24.64 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 10.0 mm Hg | Standard Deviation 26.62 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 135.6 mm Hg | Standard Deviation 20.81 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 42) | 136.9 mm Hg | Standard Deviation 18.61 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 15.9 mm Hg | Standard Deviation 25.6 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 14.4 mm Hg | Standard Deviation 26.73 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 8.5 mm Hg | Standard Deviation 18.43 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 129.2 mm Hg | Standard Deviation 13.79 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 137.0 mm Hg | Standard Deviation 18.09 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 130.6 mm Hg | Standard Deviation 23.29 |
| Group 4: Tacrolimus + MMF | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 121.2 mm Hg | Standard Deviation 17.31 |
| Group 5: Tacrolimus | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 6 months (n=43, 40, 36, 47, 37) | 132.0 mm Hg | Standard Deviation 22.11 |
| Group 5: Tacrolimus | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 9 months (n=34, 30, 29, 41, 31) | 11.6 mm Hg | Standard Deviation 20.39 |
| Group 5: Tacrolimus | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 6 months (n=43, 40, 36, 47, 36) | 8.3 mm Hg | Standard Deviation 27.45 |
| Group 5: Tacrolimus | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 12 months (n=42, 37, 36, 46, 38) | 138.0 mm Hg | Standard Deviation 18.67 |
| Group 5: Tacrolimus | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 3 months (n=44, 46, 41, 48, 42) | 133.0 mm Hg | Standard Deviation 16.18 |
| Group 5: Tacrolimus | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 12 months (n=42, 37, 36, 46, 37) | 14.6 mm Hg | Standard Deviation 25.88 |
| Group 5: Tacrolimus | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | BL (n=50, 48, 49, 53, 49) | 125.3 mm Hg | Standard Deviation 21.87 |
| Group 5: Tacrolimus | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 9 months (n=34, 30, 29, 41, 31) | 133.9 mm Hg | Standard Deviation 15.58 |
| Group 5: Tacrolimus | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | 1 month (n=50, 48, 49, 52, 48) | 124.6 mm Hg | Standard Deviation 16.41 |
| Group 5: Tacrolimus | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 1 month (n=50, 48, 49, 52, 47) | 0.6 mm Hg | Standard Deviation 24.26 |
| Group 5: Tacrolimus | Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase | Change from BL to 3 months (n=44, 46, 41, 48, 41) | 9.1 mm Hg | Standard Deviation 24.99 |