Kidney Transplantation, Chronic Kidney Failure
Conditions
Brief summary
The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.
Interventions
tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months (ST), 100-250 ng/mL, daily, 24 months (LT)
DRUGBelatacept LI (less intensive)
solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
DRUGBelatacept MI (more intensive)
solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is a recipient of a living donor or deceased donor kidney transplant. * Male or Female, 18 or older
Exclusion criteria
* First time recipient, PRA \>- 50% or for retransplantation PRA \>- 30%. * If retransplantation, previous graft loss cannot be due to acute rejection. * Positive cross match. * Subject receiving extended criteria donor (ECD) organ * For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Surviving With a Functioning Graft by Month 12 | Day 1 to Month 12 | Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromolar per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant. |
| Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12 | Month 12; Month 3 to Month 12 | Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m\^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 mg/dL. A change in GFR of at least 10 mL/min/1.73 m\^2 was used as the approximate change in SCr of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3. |
| Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12 | Day 1 to Month 12 | Acute rejection was defined as a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence was defined if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR was defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events of Special Interest by Month 84 | Randomization to Month 84 | Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections and Infestations, Thrombolic/embolic events, and Malignancy. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/ abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Time frame is from randomization to the event date, or to the last dose date+56, or to Month 84 (Day 2548), whichever is the earliest. |
| Mean Blood Pressure at Month 84 | Month 84 | Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart. |
| Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Baseline to Month 36 | Upper limit of normal (ULN). Units per Liter (U/L). Cells per microliter (c/µL). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).Cells per Liter (c/L). Milliequivalents/Liter (mEq/L). Hemoglobin (low): \<8.0 g/dL; Platelet count: \<50\*10\^9 c/L; Leukocytes: \<2\*10\^3 c/µL; Alkaline phosphatase (ALP): \>5.0\*ULN U/L; Alanine aminotransferase (ALT): \>5.0\*ULN U/L; Asparate aminotransferase (AST): \>5.0\*ULN U/L; Bilirubin Total: \>3.0\*ULN mg/dL; Creatinine: \>3.0\*ULN mg/dL; Calcium Total: low if \<7.0 mg/dL or high if \>12.5 mg/dL; Bicarbonate: \<11.0 mEq/L; Potassium serum: low if \<3.0 mEq/L or high if \>6.0 mEq/L; Magnesium serum: low is \<0.8 mEq/L or high if \>2.46 mEq/L; Sodium serum: low if \<130.0 mEq/L or high if \>155.0 mEq/L; Phosphorus inorganic: \<2.0 mg/dL; Albumin: \<2 g/dL; Uric acid: \>10 mg/dL; Protein urine: \>=3+ |
| Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 | Month 12 | Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m\^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 milligrams per deciliter (mg/dL). |
| Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84 | Randomization to Month 84 | Only participants who had non-missing test result for Class I or Class II anti-donor HLA antibodies were included in analysis and only participants who had at least one non-NA test result or finding were counted. This was a cumulative summary (excluding baseline) and once a participant was positive, that participant remained positive for the later time point. Acute rejection (AR) defined: a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence defined: if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. AR defined as allograft biopsies of Banff 97 classification Grade IA or greater (higher scores indicate more severe rejection). Evaluated by blinded central independent pathologist. |
| Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24 | Month 3 to Month 12; Month 3 to Month 24 | Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m\^2. |
| Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12 | Month 3 to Month 12 | Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A change in GFR of at least 10 mL/min/1.73 m\^2 was used as the approximate change in serum creatinine (SCr) of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3. Month 3 = baseline |
| Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation | Months 6, 12, 24, 36 | Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x \[SCr/0.95\]\^(-0.999) x \[Age\]\^(-0.176) x \[0.762 if participant is female\] x \[1.180 if participant is black\] x \[BUN\]\^(-0.170) x \[Alb\]\^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m2 |
| Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12 | Month 6 to Month 12 | Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x \[SCr/0.95\]\^(-0.999) x \[Age\]\^(-0.176) x \[0.762 if participant is female\] x \[1.180 if participant is black\] x \[BUN\]\^(-0.170) x \[Alb\]\^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m\^2 |
| Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 | Week 4 post-transplantation to Month 36 | The incidence of new onset diabetes mellitus defined as participants who developed diabetes mellitus after randomization and transplantation. Participants that did not have diabetes prior to randomization were determined to have new onset diabetes mellitus if (i) the participant received an anti-diabetic 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). New onset diabetes mellitus (NODM) = post-transplant diabetes mellitus (PTDM) |
| Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36 | Month 36 | This analysis was based on all participants who had been followed up at least 1092 days after transplantation. Hypertension was defined in according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. In addition, all participants who had a SBP \< 130 mm Hg and a DBP \< 80 mm Hg who received an antihypertensive medication(s) for the indication of hypertension or with a medical history of hypertension were included in this definition. Systolic blood pressure = SBP; Diastolic blood pressure = DBP |
| Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12 | Month 12 | The incidence of hypertension was defined as the proportion of participants who developed hypertension after randomization and transplantation. Specifically, the incidence of hypertension was assessed only after the Week 4 visit. This period allowed for adequate stabilization and resolution of transient changes. If participants received antihypertensive medication for the indication of hypertension at this (or later) time point, they were considered to have developed hypertension. Hypertension was defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for subjects with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP |
| Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12 | Month 12 | The prevalence of hypertension was defined as the proportion of participants at any given time who meet the definition of hypertension. Hypertension defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition is based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP |
| Mean Systolic Blood Pressure and Diastolic Blood Pressure | Months 12, 24, 36 | Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart. |
| Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12 | Day 1 to Month 12 | Controlled hypertension was defined as a SBP \< 130 mm Hg and a DBP \< 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP \< 130 mm Hg and a DBP \< 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP |
| Percent of Participants With Prevalence of Controlled Hypertension at Month 12 | Month 12 | The prevalence of controlled hypertension was defined as the proportion of participants at any given time who met the definition of controlled hypertension. Controlled hypertension was defined as a SBP \< 130 mm Hg and a DBP \< 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP \< 130 mm Hg and a DBP \< 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP |
| Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12 | Randomization to Month 12 | Incidence of dyslipidemia was defined as the proportion of participants who developed dyslipidemia after randomization and transplantation. Dyslipidemia was defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia = hypertriglyceridemia (TGs \>= 500 milligrams/deciliter (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 \[2.26 mmol/L\]). The TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \>=5. Otherwise exact method is used. |
| Percent of Participants With Prevalence of Dyslipidemia at Month 12 | Month 12 | The prevalence of dyslipidemia was defined as the proportion of participants at any given time who met the definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs \>= 500 milligrams/deciliter (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 \[2.26 mmol/L\]). TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \>=5. Otherwise exact method is used. |
| Percent of Participants With Controlled Dyslipidemia at Month 12 | Month 12 | Prevalence of controlled dyslipidemia = the proportion of participants at any given time who met the stated definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs \>= 500 milligrams/deciliter (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 \[2.26 mmol/L\]). Controlled dyslipidemia defined as participants who received successful pharmacologic treatment for 1 of the above stated dyslipidemias, and their lipid values fell below the thresholds described. TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \>=5. Otherwise exact method is used. |
| Number of Participants With Antihyperlipidemic Medication by Intensity Level | Month 36 | An intensity level was associated with the dose level of the statin based anti-hyperlipidemic agent. Any other agent (i.e., non-statin therapy) used as an antihyperlipidemic were considered Level I treatment intensity. Multiple daily dose levels during a period were averaged to compute the daily dose during that period. Level I = 20 mg fluvastatin (flu), 10 mg lovastatin (lova), 10 mg pravastatin (prav), 5-10 mg simvastatin (sim); Level II = 10 mg atorvastatin (atorv), 40 mg flu, 20 mg lova, 20 mg prav, 5 mg rosuvastatin (rosu), 20 mg sim, 10/10 vytorin; Level III = 20 mg atorv, 80 mg flu, 40 mg lova, 40 mg prav, 10 mg rosu, 40 mg sim, 10/20 vytorin; Level IV = 40 mg atorv, 80 mg lova, 80 mg prav, 20 mg rosu, 80 mg sim, 10/40 vytorin; Level V = 80 mg atorv, 40 mg rosu, 10/80 vytorin. Concomitant use of a statin and an agent of another class elevated the intensity level of the statin therapy by 1 level; therefore, an intensity level of greater than V was possible. |
| Percent of Participants Using At Least One Anti-Hyperlipidemic Medication | Month 36 | This analysis is based on all participants who were followed up at least 1092 days after transplantation. |
| Mean Value of Lipid Parameters | Months 12, 24, 36 | Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, non-HDL cholesterol, and triglycerides (TGs). |
| Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 | Randomization to Month 36 | Prevalence of AR = participants with the stated definition of AR at any given time. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. |
| Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Randomization to Month 36 | Acute rejection was defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted. |
| Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12 | Randomization to Month 12 | A participant was considered to have delayed graft function (DGF), if treated with dialysis within the first week (Day 1 - 8) after transplantation. The use of polyclonal antilymphocyte preparations (LDT) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated DGF following transplantation and were not permitted in belatacept-treated participants, except for the treatment of acute rejection. Participants treated with LDT began CsA at the discretion of the investigator by Day 7. LDT could also have been used in participants who met \>= 1 of the following criteria, observed in the presence of a transplant artery and vein and no evidence of hydronephrosis by sonogram: Urine output \< 250 mL/12 hours, no significant improvement (\< 1 milligram per deciliter (mg/dL)) in serum creatinine from baseline value over the first 24 - 72 hours post-transplant, or dialysis treatment. |
| Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 | Randomization to Month 36 | The use of LDT (thymoglobulin or antithymocyte gamma globulin \[ATGAM\]) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated delayed graft function following transplantation. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence (an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed) and biopsy confirmation. AR defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted. |
| Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 | Randomization to Month 36 | Steroid-resistant acute rejection (AR) defined as the use of lymphocyte-depletion therapy following treatment with corticosteroids. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 international standardized histopathological working classification of kidney transplant pathology. Only the episode with the highest Banff grade for each participant was counted. |
| Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12 | Randomization to Month 12 | Acute rejection (AR) = a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Complete recovery following AR defined as serum creatinine \[SCr\] levels returned to baseline. Recovery calculated using 2 algorithms: Algorithm 1 = last laboratory measurement prior to onset of AR (baseline and first laboratory measurement after 84 days since onset of AR = resolution); Algorithm 2 = lowest laboratory measurement on or after transplantation and prior to onset day of AR (baseline and lowest laboratory measurement after onset on first AR up to Month 12 = resolution) |
| Percent of Participants With Subclinical Rejection at Month 12 | Month 12 | Subclinical rejection defined as histological findings by the central pathologist consistent with acute rejection, but lacking its clinical correlate. Acute rejection defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence defined if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. |
| Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 | Randomization to Month 36 | Allograft rejection includes any episode of rejection including: clinically suspected rejection, treated rejection, any central biopsy-proven acute rejection (BPAR), and acute rejection (AR: a subset of BPAR) defined as central biopsy-proven rejection that was either clinically suspected by protocol-defined reasons or by other reasons and was treated. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence ( either an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of AR) and renal biopsy confirmation biopsy demonstrating a Banff 97 working classification of kidney transplant pathology classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the highest Banff grade for each participant was counted. |
| Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Months 6, 12, 24, 36 | SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm. |
| Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Months 6, 12, 24, 36 | SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm. |
| Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Months 6, 12, 24, 36 | The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley & Sons, Inc. 1991) was used. Ridit scores were calculated at baseline and at 6, 12, 24, and 36 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5. |
| Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Baseline to Months 6, 12, 24,and 36 | SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm. |
| Mean Value of the Measured Glomerular Filtration Rate (mGFR) | Months 3, 12, 24 | Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m\^2. |
| Percent of Participants Surviving With a Functioning Graft | Months 24, 36 | Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant. |
| Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 | Randomization to Month 36 | Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant. Acute rejection was defined as central biopsy proven rejection that was either (1) clinically suspected by protocol defined reasons or (2) clinically suspected by other reasons and treated. Death and graft loss were not imputed. |
| Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Baseline to Months 6, 12, 24, and 36 | SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm. |
| Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12 | Month 12 | Prevalence of CAN = if participant met any of the following conditions: a: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; b: participant had graft loss during the first year post transplant; c: no biopsy was available post 12 months and CAN not observed in biopsies prior to 12 months, but the measured GFR from Month 3 to Month 12 decreased at least 10 mL/min/1.73m\^2; d: no biopsy available either prior to or post 12 months, and the measured GFR (incorporated missing data imputation) from Month 3 to Month 12 decreased at least 10 mL/min/1.73m\^2. CAN = All allograft biopsies evaluated for presence and severity of CAN by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Onset of CAN determined by the biopsy date when it was observed. |
| Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 | Randomization to Month 84 | Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, India, Israel, Italy, Mexico, Poland, South Africa, Spain, Sweden, Switzerland, Turkey (Türkiye), United States
Participant flow
Pre-assignment details
738 participants enrolled, 686 randomized. Reasons for non-randomization include 5 participants withdrew consent, 1 lost to follow-up, 34 no longer met study criteria, and 12 for other non-listed reasons. 666 participants randomized, but not transplanted. 20 not transplanted; 10, 4, 6 in the CsA, Belatacept LI, Belatacept MI, respectively.
Participants by arm
| Arm | Count |
|---|---|
| Cyclosporine Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT) | 221 |
| Belatacept LI Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT) | 226 |
| Belatacept MI Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT) | 219 |
| Total | 666 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Long Term Extension (LTE; 84 Months) | Administrative Reason By Sponsor | 1 | 1 | 0 |
| Long Term Extension (LTE; 84 Months) | Adverse Event | 13 | 11 | 14 |
| Long Term Extension (LTE; 84 Months) | Death | 9 | 4 | 4 |
| Long Term Extension (LTE; 84 Months) | Lack of Efficacy | 6 | 3 | 0 |
| Long Term Extension (LTE; 84 Months) | Lost to Follow-up | 4 | 1 | 1 |
| Long Term Extension (LTE; 84 Months) | Other | 5 | 4 | 5 |
| Long Term Extension (LTE; 84 Months) | Poor/Non-compliance | 4 | 1 | 1 |
| Long Term Extension (LTE; 84 Months) | Pregnancy | 0 | 1 | 2 |
| Long Term Extension (LTE; 84 Months) | Withdrawal by Subject | 5 | 4 | 1 |
| Post-Transplant Treated (12 Months) | Adverse Event | 20 | 12 | 8 |
| Post-Transplant Treated (12 Months) | Death | 3 | 2 | 4 |
| Post-Transplant Treated (12 Months) | Lack of Efficacy | 10 | 22 | 27 |
| Post-Transplant Treated (12 Months) | Lost to Follow-up | 1 | 0 | 0 |
| Post-Transplant Treated (12 Months) | Other | 5 | 4 | 2 |
| Post-Transplant Treated (12 Months) | Protocol Violation | 2 | 0 | 0 |
| Post-Transplant Treated (12 Months) | Withdrawal by Subject | 0 | 3 | 5 |
| Post-Transplant Treated (24 Months) | Adverse Event | 7 | 3 | 6 |
| Post-Transplant Treated (24 Months) | Death | 3 | 0 | 0 |
| Post-Transplant Treated (24 Months) | Lack of Efficacy | 4 | 3 | 2 |
| Post-Transplant Treated (24 Months) | Other | 2 | 0 | 1 |
| Post-Transplant Treated (24 Months) | Withdrawal by Subject | 5 | 1 | 0 |
| Post-Transplant Treated (36 Months) | Adverse Event | 5 | 1 | 2 |
| Post-Transplant Treated (36 Months) | Death | 0 | 2 | 1 |
| Post-Transplant Treated (36 Months) | Lack of Efficacy | 4 | 1 | 0 |
| Post-Transplant Treated (36 Months) | Other | 0 | 1 | 1 |
| Post-Transplant Treated (36 Months) | Protocol Violation | 0 | 1 | 0 |
| Post-Transplant Treated (36 Months) | Subject no longer meets study criteria | 0 | 0 | 1 |
| Post-Transplant Treated (36 Months) | Withdrawal by Subject | 1 | 0 | 1 |
| Transplanted Pre-Treatment | Death | 1 | 0 | 0 |
| Transplanted Pre-Treatment | Other | 2 | 0 | 0 |
| Transplanted Pre-Treatment | Withdrawal by Subject | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Cyclosporine | Belatacept LI | Belatacept MI |
|---|---|---|---|---|
| Age, Continuous | 43.2 years STANDARD_DEVIATION 14.1 | 43.5 years STANDARD_DEVIATION 14.3 | 42.6 years STANDARD_DEVIATION 13.4 | 43.6 years STANDARD_DEVIATION 14.6 |
| Age, Customized > 65 years: | 34 participants | 10 participants | 9 participants | 15 participants |
| Age, Customized Between 18 and 45 years: | 345 participants | 110 participants | 124 participants | 111 participants |
| Age, Customized Between 46 and 65 years: | 287 participants | 101 participants | 93 participants | 93 participants |
| Previous Number of Transplant 0 | 636 participants | 208 participants | 218 participants | 210 participants |
| Previous Number of Transplant 1 | 19 participants | 9 participants | 5 participants | 5 participants |
| Previous Number of Transplant 2 | 1 participants | 0 participants | 0 participants | 1 participants |
| Previous Number of Transplant Missing | 10 participants | 4 participants | 3 participants | 3 participants |
| Sex: Female, Male Female | 204 Participants | 56 Participants | 80 Participants | 68 Participants |
| Sex: Female, Male Male | 462 Participants | 165 Participants | 146 Participants | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 213 / 215 | 222 / 226 | 216 / 219 |
| serious Total, serious adverse events | 167 / 215 | 160 / 226 | 164 / 219 |
Outcome results
Primary
Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12
Acute rejection was defined as a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence was defined if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR was defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted.
Time frame: Day 1 to Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12 | 7.2 percentage of participants |
| Belatacept LI | Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12 | 17.3 percentage of participants |
| Belatacept MI | Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12 | 21.9 percentage of participants |
97.3% CI: [3.3, 17.1]
97.3% CI: [7.5, 22.2]
Primary
Percent of Participants Surviving With a Functioning Graft by Month 12
Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromolar per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.
Time frame: Day 1 to Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants Surviving With a Functioning Graft by Month 12 | 92.8 percentage of participants |
| Belatacept LI | Percent of Participants Surviving With a Functioning Graft by Month 12 | 96.5 percentage of participants |
| Belatacept MI | Percent of Participants Surviving With a Functioning Graft by Month 12 | 95.4 percentage of participants |
97.3% CI: [-1.1, 9]
97.3% CI: [-2.5, 8.1]
Primary
Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12
Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m\^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 mg/dL. A change in GFR of at least 10 mL/min/1.73 m\^2 was used as the approximate change in SCr of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3.
Time frame: Month 12; Month 3 to Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12 | 77.9 percentage of participants |
| Belatacept LI | Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12 | 54.2 percentage of participants |
| Belatacept MI | Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12 | 55.0 percentage of participants |
p-value: <0.000197.3% CI: [-33.3, -13.7]Chi-squared, Corrected
p-value: <0.000197.3% CI: [-32.6, -12.9]Chi-squared, Corrected
Secondary
Mean Blood Pressure at Month 84
Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.
Time frame: Month 84
Population: All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Mean Blood Pressure at Month 84 | Diastolic Blood Pressure (n=82, 125, 112) | 78.6 mmHg | Standard Deviation 11.03 |
| Cyclosporine | Mean Blood Pressure at Month 84 | Systolic Blood Pressure (n=82, 125, 112) | 129.0 mmHg | Standard Deviation 15.83 |
| Belatacept LI | Mean Blood Pressure at Month 84 | Diastolic Blood Pressure (n=82, 125, 112) | 75.8 mmHg | Standard Deviation 10.56 |
| Belatacept LI | Mean Blood Pressure at Month 84 | Systolic Blood Pressure (n=82, 125, 112) | 126.7 mmHg | Standard Deviation 18.17 |
| Belatacept MI | Mean Blood Pressure at Month 84 | Systolic Blood Pressure (n=82, 125, 112) | 126.0 mmHg | Standard Deviation 17.56 |
| Belatacept MI | Mean Blood Pressure at Month 84 | Diastolic Blood Pressure (n=82, 125, 112) | 75.1 mmHg | Standard Deviation 10.15 |
Secondary
Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12
Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x \[SCr/0.95\]\^(-0.999) x \[Age\]\^(-0.176) x \[0.762 if participant is female\] x \[1.180 if participant is black\] x \[BUN\]\^(-0.170) x \[Alb\]\^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m\^2
Time frame: Month 6 to Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cyclosporine | Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12 | 2.3 mL/Min/1.73 m^2 | Standard Deviation 10.09 |
| Belatacept LI | Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12 | 4.7 mL/Min/1.73 m^2 | Standard Deviation 11.52 |
| Belatacept MI | Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12 | 5.1 mL/Min/1.73 m^2 | Standard Deviation 11.37 |
Secondary
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36
SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.
Time frame: Baseline to Months 6, 12, 24, and 36
Population: All randomized and transplanted participants, intent to treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Vitality, Month 24 (n=193,203,196) | 6.2 units on a scale | Standard Error 0.7 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Health, Month 6 (n=188,198,190) | 4.7 units on a scale | Standard Error 0.716 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Functioning, Month 12 (n=194,206,194) | 4.7 units on a scale | Standard Error 0.64 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role Emotional, Month 36 (n=192,207,195) | 3.3 units on a scale | Standard Error 0.83 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Functioning, Month 6 (n=189,201,190) | 4.7 units on a scale | Standard Error 0.61 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role Emotional, Month 12 (n=192,205,191) | 5.7 units on a scale | Standard Error 0.765 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Social Functioning, Month 24 (n=193, 207,197) | 5.9 units on a scale | Standard Error 0.722 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | General Health, Month 12 (n=194,206,195) | 6.0 units on a scale | Standard Error 0.638 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role-Physical, Month 12 (n=193,205,191) | 8.3 units on a scale | Standard Error 0.716 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role-Physical, Month 36 (n=192,207,195) | 6.8 units on a scale | Standard Error 0.754 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role Emotional, Month 6 (n=188,200,186) | 4.7 units on a scale | Standard Error 0.767 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Social Functioning, Month 12 (n=194,205,195) | 6.4 units on a scale | Standard Error 0.669 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | General Health, Month 36 (n=193,207,197) | 4.1 units on a scale | Standard Error 0.681 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Vitality, Month 6 (n=188,198,190) | 7.5 units on a scale | Standard Error 0.668 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Vitality, Month 12 (n=194,203,195) | 7.0 units on a scale | Standard Error 0.651 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Social Functioning, Month 36 (n=192,207,197) | 5.1 units on a scale | Standard Error 0.736 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Health, Month 36 (n=191,204,195) | 1.8 units on a scale | Standard Error 0.754 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Bodily Pain, Month 24 (n=192,207,197) | 3.2 units on a scale | Standard Error 0.722 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Bodily Pain, Month 12 (n=194,205,195) | 3.1 units on a scale | Standard Error 0.665 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role-Physical, Month 6 (n=188,201,187) | 6.4 units on a scale | Standard Error 0.718 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | General Health, Month 24 (n=193,207,197) | 5.1 units on a scale | Standard Error 0.641 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Bodily Pain, Month 36 (n=191,207,196) | 2.3 units on a scale | Standard Error 0.739 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Vitality, Month 36 (n=191,204,195) | 4.9 units on a scale | Standard Error 0.721 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Health, Month 24 (n=193,203,195) | 3.2 units on a scale | Standard Error 0.71 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Functioning, Month 36 (n=192,206,197) | 4.4 units on a scale | Standard Error 0.692 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | General Health, Month 6 (n=189,201,190) | 6.7 units on a scale | Standard Error 0.631 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Functioning, Month 24 (n=193,207,197) | 4.1 units on a scale | Standard Error 0.685 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Health, Month 12 (n=194,203,195) | 4.4 units on a scale | Standard Error 0.685 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Social Functioning, Month 6 (n=189,201,190) | 6.0 units on a scale | Standard Error 0.724 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role Emotional, Month 24 (n=192,206,196) | 4.7 units on a scale | Standard Error 0.793 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Bodily Pain, Month 6 (n=189,201,189) | 2.9 units on a scale | Standard Error 0.712 |
| Cyclosporine | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role-Physical, Month 24 (n=193,207,195) | 7.4 units on a scale | Standard Error 0.74 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Social Functioning, Month 6 (n=189,201,190) | 6.8 units on a scale | Standard Error 0.702 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role-Physical, Month 24 (n=193,207,195) | 9.4 units on a scale | Standard Error 0.715 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | General Health, Month 6 (n=189,201,190) | 7.1 units on a scale | Standard Error 0.612 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Social Functioning, Month 24 (n=193, 207,197) | 7.4 units on a scale | Standard Error 0.697 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Vitality, Month 24 (n=193,203,196) | 7.9 units on a scale | Standard Error 0.682 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Vitality, Month 6 (n=188,198,190) | 9.0 units on a scale | Standard Error 0.651 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Bodily Pain, Month 36 (n=191,207,196) | 4.2 units on a scale | Standard Error 0.71 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Health, Month 36 (n=191,204,195) | 4.1 units on a scale | Standard Error 0.729 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | General Health, Month 36 (n=193,207,197) | 6.6 units on a scale | Standard Error 0.657 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Bodily Pain, Month 12 (n=194,205,195) | 4.8 units on a scale | Standard Error 0.647 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Functioning, Month 36 (n=192,206,197) | 5.3 units on a scale | Standard Error 0.668 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role Emotional, Month 36 (n=192,207,195) | 5.6 units on a scale | Standard Error 0.8 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role-Physical, Month 36 (n=192,207,195) | 9.2 units on a scale | Standard Error 0.727 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | General Health, Month 12 (n=194,206,195) | 7.7 units on a scale | Standard Error 0.619 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Social Functioning, Month 36 (n=192,207,197) | 7.0 units on a scale | Standard Error 0.708 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Health, Month 6 (n=188,198,190) | 5.2 units on a scale | Standard Error 0.698 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Vitality, Month 36 (n=191,204,195) | 7.3 units on a scale | Standard Error 0.698 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Health, Month 12 (n=194,203,195) | 6.0 units on a scale | Standard Error 0.67 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Bodily Pain, Month 6 (n=189,201,189) | 4.5 units on a scale | Standard Error 0.691 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Functioning, Month 12 (n=194,206,194) | 6.2 units on a scale | Standard Error 0.621 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role Emotional, Month 12 (n=192,205,191) | 6.6 units on a scale | Standard Error 0.741 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Functioning, Month 6 (n=189,201,190) | 5.3 units on a scale | Standard Error 0.592 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role-Physical, Month 12 (n=193,205,191) | 10.3 units on a scale | Standard Error 0.695 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Social Functioning, Month 12 (n=194,205,195) | 7.7 units on a scale | Standard Error 0.65 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role Emotional, Month 6 (n=188,200,186) | 5.8 units on a scale | Standard Error 0.744 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Vitality, Month 12 (n=194,203,195) | 9.2 units on a scale | Standard Error 0.636 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Bodily Pain, Month 24 (n=192,207,197) | 3.3 units on a scale | Standard Error 0.696 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | General Health, Month 24 (n=193,207,197) | 7.2 units on a scale | Standard Error 0.619 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role-Physical, Month 6 (n=188,201,187) | 8.4 units on a scale | Standard Error 0.694 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Health, Month 24 (n=193,203,195) | 4.6 units on a scale | Standard Error 0.692 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Functioning, Month 24 (n=193,207,197) | 5.7 units on a scale | Standard Error 0.662 |
| Belatacept LI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role Emotional, Month 24 (n=192,206,196) | 6.0 units on a scale | Standard Error 0.766 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Functioning, Month 24 (n=193,207,197) | 5.5 units on a scale | Standard Error 0.679 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Bodily Pain, Month 6 (n=189,201,189) | 4.6 units on a scale | Standard Error 0.712 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | General Health, Month 6 (n=189,201,190) | 7.3 units on a scale | Standard Error 0.63 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Health, Month 6 (n=188,198,190) | 6.1 units on a scale | Standard Error 0.712 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role Emotional, Month 6 (n=188,200,186) | 6.9 units on a scale | Standard Error 0.772 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role-Physical, Month 6 (n=188,201,187) | 9.6 units on a scale | Standard Error 0.72 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Social Functioning, Month 6 (n=189,201,190) | 6.9 units on a scale | Standard Error 0.722 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Vitality, Month 6 (n=188,198,190) | 9.9 units on a scale | Standard Error 0.665 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Bodily Pain, Month 12 (n=194,205,195) | 5.5 units on a scale | Standard Error 0.664 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | General Health, Month 12 (n=194,206,195) | 7.6 units on a scale | Standard Error 0.636 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Health, Month 12 (n=194,203,195) | 5.0 units on a scale | Standard Error 0.684 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Functioning, Month 12 (n=194,206,194) | 5.8 units on a scale | Standard Error 0.641 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role Emotional, Month 12 (n=192,205,191) | 5.9 units on a scale | Standard Error 0.768 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role-Physical, Month 12 (n=193,205,191) | 10.4 units on a scale | Standard Error 0.72 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Social Functioning, Month 12 (n=194,205,195) | 8.0 units on a scale | Standard Error 0.667 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Vitality, Month 12 (n=194,203,195) | 9.7 units on a scale | Standard Error 0.649 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Bodily Pain, Month 24 (n=192,207,197) | 4.1 units on a scale | Standard Error 0.713 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | General Health, Month 24 (n=193,207,197) | 6.8 units on a scale | Standard Error 0.635 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Health, Month 24 (n=193,203,195) | 4.0 units on a scale | Standard Error 0.706 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Functioning, Month 6 (n=189,201,190) | 5.6 units on a scale | Standard Error 0.61 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role Emotional, Month 24 (n=192,206,196) | 5.9 units on a scale | Standard Error 0.785 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role-Physical, Month 24 (n=193,207,195) | 10.7 units on a scale | Standard Error 0.737 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Social Functioning, Month 24 (n=193, 207,197) | 6.3 units on a scale | Standard Error 0.715 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Vitality, Month 24 (n=193,203,196) | 8.0 units on a scale | Standard Error 0.695 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Bodily Pain, Month 36 (n=191,207,196) | 3.0 units on a scale | Standard Error 0.73 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | General Health, Month 36 (n=193,207,197) | 5.8 units on a scale | Standard Error 0.674 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Health, Month 36 (n=191,204,195) | 3.4 units on a scale | Standard Error 0.746 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Functioning, Month 36 (n=192,206,197) | 5.1 units on a scale | Standard Error 0.684 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role Emotional, Month 36 (n=192,207,195) | 5.0 units on a scale | Standard Error 0.824 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Role-Physical, Month 36 (n=192,207,195) | 8.9 units on a scale | Standard Error 0.749 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Social Functioning, Month 36 (n=192,207,197) | 5.6 units on a scale | Standard Error 0.726 |
| Belatacept MI | Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Vitality, Month 36 (n=191,204,195) | 7.3 units on a scale | Standard Error 0.714 |
Secondary
Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24
Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m\^2.
Time frame: Month 3 to Month 12; Month 3 to Month 24
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24 | Baseline (Month 3) to Month 12 (n=195, 206, 200) | -1.7 mL/min/1.73m^2 | Standard Deviation 21.58 |
| Cyclosporine | Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24 | Baseline (Month 3) to Month 24 (n=184, 199, 192) | -2.0 mL/min/1.73m^2 | Standard Deviation 25.23 |
| Belatacept LI | Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24 | Baseline (Month 3) to Month 12 (n=195, 206, 200) | 1.2 mL/min/1.73m^2 | Standard Deviation 30.43 |
| Belatacept LI | Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24 | Baseline (Month 3) to Month 24 (n=184, 199, 192) | 5.3 mL/min/1.73m^2 | Standard Deviation 33.03 |
| Belatacept MI | Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24 | Baseline (Month 3) to Month 12 (n=195, 206, 200) | 4.4 mL/min/1.73m^2 | Standard Deviation 31.1 |
| Belatacept MI | Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24 | Baseline (Month 3) to Month 24 (n=184, 199, 192) | 4.2 mL/min/1.73m^2 | Standard Deviation 30.96 |
Secondary
Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36
SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.
Time frame: Baseline to Months 6, 12, 24,and 36
Population: All randomized and transplanted participants, intent to treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Component Score; Month 6 (n=187, 197, 184) | 5.4 units on a scale | Standard Deviation 0.714 |
| Cyclosporine | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Component Score; Month 6 (n=187, 197, 184 | 5.0 units on a scale | Standard Deviation 0.58 |
| Cyclosporine | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Component Score; Month 12 (n=192, 200, 189) | 5.4 units on a scale | Standard Deviation 0.687 |
| Cyclosporine | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Component Score; Month 12 (n=192,200,189) | 5.5 units on a scale | Standard Deviation 0.589 |
| Cyclosporine | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Component Score; Month 24 (n=191,202,193) | 4.4 units on a scale | Standard Deviation 0.732 |
| Cyclosporine | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Component Score; Month 24 (n=191,202,193) | 5.1 units on a scale | Standard Deviation 0.601 |
| Cyclosporine | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Component Score; Month 36 (n=190,203,191) | 2.6 units on a scale | Standard Deviation 0.756 |
| Cyclosporine | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Component Score; Month 36 (n=190,203,191) | 4.9 units on a scale | Standard Deviation 0.633 |
| Belatacept LI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Component Score; Month 12 (n=192, 200, 189) | 6.8 units on a scale | Standard Deviation 0.673 |
| Belatacept LI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Component Score; Month 36 (n=190,203,191) | 5.1 units on a scale | Standard Deviation 0.732 |
| Belatacept LI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Component Score; Month 12 (n=192,200,189) | 7.1 units on a scale | Standard Deviation 0.577 |
| Belatacept LI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Component Score; Month 24 (n=191,202,193) | 5.7 units on a scale | Standard Deviation 0.712 |
| Belatacept LI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Component Score; Month 24 (n=191,202,193) | 6.5 units on a scale | Standard Deviation 0.584 |
| Belatacept LI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Component Score; Month 6 (n=187, 197, 184) | 6.2 units on a scale | Standard Deviation 0.695 |
| Belatacept LI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Component Score; Month 6 (n=187, 197, 184 | 6.2 units on a scale | Standard Deviation 0.566 |
| Belatacept LI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Component Score; Month 36 (n=190,203,191) | 6.5 units on a scale | Standard Deviation 0.612 |
| Belatacept MI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Component Score; Month 12 (n=192, 200, 189) | 6.2 units on a scale | Standard Deviation 0.693 |
| Belatacept MI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Component Score; Month 6 (n=187, 197, 184 | 6.7 units on a scale | Standard Deviation 0.585 |
| Belatacept MI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Component Score; Month 6 (n=187, 197, 184) | 7.3 units on a scale | Standard Deviation 0.72 |
| Belatacept MI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Component Score; Month 12 (n=192,200,189) | 7.8 units on a scale | Standard Deviation 0.594 |
| Belatacept MI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Component Score; Month 36 (n=190,203,191) | 4.5 units on a scale | Standard Deviation 0.754 |
| Belatacept MI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Component Score; Month 24 (n=191,202,193) | 7.3 units on a scale | Standard Deviation 0.597 |
| Belatacept MI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Mental Component Score; Month 24 (n=191,202,193) | 5.1 units on a scale | Standard Deviation 0.728 |
| Belatacept MI | Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 | Physical Component Score; Month 36 (n=190,203,191) | 6.1 units on a scale | Standard Deviation 0.631 |
Comparison: Mental Component Score; Month 6p-value: 0.449895% CI: [-1.2, 2.7]ANCOVA
Comparison: Mental Component Score; Month 6p-value: 0.058495% CI: [-0.1, 3.9]ANCOVA
Comparison: Physical Component Score; Month 6p-value: 0.159595% CI: [-0.5, 2.7]ANCOVA
Comparison: Physical Component Score; Month 6p-value: 0.045795% CI: [0, 3.3]ANCOVA
Comparison: Mental Component Score; Month 12p-value: 0.172995% CI: [-0.6, 3.2]ANCOVA
Comparison: Mental Component Score; Month 12p-value: 0.420995% CI: [-1.1, 2.7]ANCOVA
Comparison: Physical Component Score; Month 12p-value: 0.052695% CI: [0, 3.2]ANCOVA
Comparison: Physical Component Score; Month 12p-value: 0.007795% CI: [0.6, 3.9]ANCOVA
Comparison: Mental Component Score; Month 24p-value: 0.184995% CI: [-0.6, 3.4]ANCOVA
Comparison: Mental Component Score; Month 24p-value: 0.463395% CI: [-1.3, 2.8]ANCOVA
Comparison: Physical Component Score; Month 24p-value: 0.097195% CI: [-0.3, 3]ANCOVA
Comparison: Physical Component Score; Month 24p-value: 0.010295% CI: [0.5, 3.8]ANCOVA
Comparison: Mental Component Score; Month 36p-value: 0.018695% CI: [0.4, 4.5]ANCOVA
Comparison: Mental Component Score; Month 36p-value: 0.077595% CI: [-0.2, 4]ANCOVA
Comparison: Physical Component Score; Month 36p-value: 0.076895% CI: [-0.2, 3.3]ANCOVA
Comparison: Physical Component Score; Month 36p-value: 0.187695% CI: [-0.6, 2.9]ANCOVA
Secondary
Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R)
The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley & Sons, Inc. 1991) was used. Ridit scores were calculated at baseline and at 6, 12, 24, and 36 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.
Time frame: Months 6, 12, 24, 36
Population: All randomized and transplanted participants, intent to treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Distress, Month 6 (n=157, 164, 155) | 0.4643 Ridit score | Standard Error 0.00452 |
| Cyclosporine | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Occurrence, Month 6 (n=166, 176, 165) | 0.4721 Ridit score | Standard Error 0.00463 |
| Cyclosporine | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Distress, Month 12 (n=169, 185, 169) | 0.4751 Ridit score | Standard Error 0.00453 |
| Cyclosporine | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Occurrence, Month 12 (n=173, 188, 173) | 0.4776 Ridit score | Standard Error 0.00458 |
| Cyclosporine | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Distress, Month 24 (n=182, 195, 179) | 0.4798 Ridit score | Standard Error 0.00443 |
| Cyclosporine | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Occurrence, Month 24 (n=184, 197, 184) | 0.4804 Ridit score | Standard Error 0.00446 |
| Cyclosporine | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Distress, Month 36 (n=184, 196, 183) | 0.5000 Ridit score | Standard Error 0.00456 |
| Cyclosporine | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Occurrence, Month 36 (n=186, 197, 187) | 0.5000 Ridit score | Standard Error 0.00459 |
| Belatacept LI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Distress, Month 12 (n=169, 185, 169) | 0.4510 Ridit score | Standard Error 0.00397 |
| Belatacept LI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Distress, Month 36 (n=184, 196, 183) | 0.4746 Ridit score | Standard Error 0.00408 |
| Belatacept LI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Occurrence, Month 12 (n=173, 188, 173) | 0.4519 Ridit score | Standard Error 0.00411 |
| Belatacept LI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Distress, Month 24 (n=182, 195, 179) | 0.4584 Ridit score | Standard Error 0.00397 |
| Belatacept LI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Occurrence, Month 24 (n=184, 197, 184) | 0.4574 Ridit score | Standard Error 0.00406 |
| Belatacept LI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Distress, Month 6 (n=157, 164, 155) | 0.4407 Ridit score | Standard Error 0.00404 |
| Belatacept LI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Occurrence, Month 6 (n=166, 176, 165) | 0.4495 Ridit score | Standard Error 0.00425 |
| Belatacept LI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Occurrence, Month 36 (n=186, 197, 187) | 0.4732 Ridit score | Standard Error 0.00421 |
| Belatacept MI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Distress, Month 12 (n=169, 185, 169) | 0.4546 Ridit score | Standard Error 0.00421 |
| Belatacept MI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Occurrence, Month 6 (n=166, 176, 165) | 0.4459 Ridit score | Standard Error 0.00432 |
| Belatacept MI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Distress, Month 6 (n=157, 164, 155) | 0.4451 Ridit score | Standard Error 0.00422 |
| Belatacept MI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Occurrence, Month 12 (n=173, 188, 173) | 0.4525 Ridit score | Standard Error 0.0043 |
| Belatacept MI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Distress, Month 36 (n=184, 196, 183) | 0.4892 Ridit score | Standard Error 0.00442 |
| Belatacept MI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Occurrence, Month 24 (n=184, 197, 184) | 0.4593 Ridit score | Standard Error 0.00423 |
| Belatacept MI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Distress, Month 24 (n=182, 195, 179) | 0.4646 Ridit score | Standard Error 0.00424 |
| Belatacept MI | Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) | Symptom Occurrence, Month 36 (n=186, 197, 187) | 0.4846 Ridit score | Standard Error 0.00441 |
Comparison: Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.p-value: <0.000195% CI: [-0.032, -0.015]z-test
Comparison: Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.p-value: <0.000195% CI: [-0.028, -0.011]z-test
Comparison: Symptom Occurrence, Month 6.p-value: <0.000195% CI: [-0.031, -0.014]z-test
Comparison: Symptom Occurrence, Month 6.p-value: <0.000195% CI: [-0.035, -0.017]z-test
Comparison: Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.p-value: <0.000195% CI: [-0.032, -0.016]z-test
Comparison: Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.p-value: <0.000195% CI: [-0.029, -0.012]z-test
Comparison: Symptom Occurrence, Month 12.p-value: <0.000195% CI: [-0.034, -0.017]z-test
Comparison: Symptom Occurrence, Month 12.p-value: <0.000195% CI: [-0.034, -0.016]z-test
Comparison: Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.p-value: <0.000195% CI: [-0.03, -0.013]z-test
Comparison: Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.p-value: <0.000195% CI: [-0.024, -0.007]z-test
Comparison: Symptom Occurrence, Month 24p-value: <0.000195% CI: [-0.031, -0.015]z-test
Comparison: Symptom Occurrence, Month 24p-value: <0.000195% CI: [-0.03, -0.013]z-test
Secondary
Mean Systolic Blood Pressure and Diastolic Blood Pressure
Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.
Time frame: Months 12, 24, 36
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Diastolic; Month 36 (n=145, 180, 166) | 79.5 mmHg | Standard Deviation 9.16 |
| Cyclosporine | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Systolic; Month 24 (n=160, 185, 174) | 135.4 mmHg | Standard Deviation 19.71 |
| Cyclosporine | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Systolic; Month 36 (n=145, 180, 166) | 133.5 mmHg | Standard Deviation 17.93 |
| Cyclosporine | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Systolic; Month 12 (n=188, 193, 191) | 138.7 mmHg | Standard Deviation 19.98 |
| Cyclosporine | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Diastolic; Month 24 (n=160, 185, 174) | 80.3 mmHg | Standard Deviation 10.2 |
| Cyclosporine | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Diastolic; Month 12 (n=188, 193, 191) | 81.9 mmHg | Standard Deviation 11.1 |
| Belatacept LI | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Diastolic; Month 24 (n=160, 185, 174) | 78.3 mmHg | Standard Deviation 10.51 |
| Belatacept LI | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Systolic; Month 36 (n=145, 180, 166) | 127.7 mmHg | Standard Deviation 16.48 |
| Belatacept LI | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Diastolic; Month 12 (n=188, 193, 191) | 78.7 mmHg | Standard Deviation 10.91 |
| Belatacept LI | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Diastolic; Month 36 (n=145, 180, 166) | 76.6 mmHg | Standard Deviation 9.75 |
| Belatacept LI | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Systolic; Month 12 (n=188, 193, 191) | 131.4 mmHg | Standard Deviation 16.54 |
| Belatacept LI | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Systolic; Month 24 (n=160, 185, 174) | 130.5 mmHg | Standard Deviation 17.35 |
| Belatacept MI | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Systolic; Month 24 (n=160, 185, 174) | 129.8 mmHg | Standard Deviation 16.84 |
| Belatacept MI | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Systolic; Month 12 (n=188, 193, 191) | 132.7 mmHg | Standard Deviation 16.21 |
| Belatacept MI | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Diastolic; Month 12 (n=188, 193, 191) | 79.3 mmHg | Standard Deviation 11.54 |
| Belatacept MI | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Diastolic; Month 36 (n=145, 180, 166) | 76.1 mmHg | Standard Deviation 11.2 |
| Belatacept MI | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Diastolic; Month 24 (n=160, 185, 174) | 77.8 mmHg | Standard Deviation 10.31 |
| Belatacept MI | Mean Systolic Blood Pressure and Diastolic Blood Pressure | Systolic; Month 36 (n=145, 180, 166) | 126.0 mmHg | Standard Deviation 16.14 |
Comparison: Systolic, Month 1297.3% CI: [-11.4, -3.3]
Comparison: Systolic, Month 1297.3% CI: [-10.1, -2]
Comparison: Diastolic, Month 1297.3% CI: [-5.8, -0.7]
Comparison: Diastolic, Month 1297.3% CI: [-5.1, 0]
Comparison: Systolic, Month 2497.3% CI: [-9.2, -0.6]
Comparison: Systolic, Month 2497.3% CI: [-9.9, -1.1]
Comparison: Diastolic, Month 2497.3% CI: [-4.4, 0.5]
Comparison: Diastolic, Month 2497.3% CI: [-5, 0.1]
Comparison: Systolic, Month 3697.3% CI: [-10, -1.6]
Comparison: Systolic, Month 3697.3% CI: [-11.7, -3.3]
Comparison: Diastolic, Month 3697.3% CI: [-5.4, -0.4]
Comparison: Diastolic, Month 3697.3% CI: [-6, -0.9]
Secondary
Mean Value of Lipid Parameters
Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, non-HDL cholesterol, and triglycerides (TGs).
Time frame: Months 12, 24, 36
Population: All randomized and transplanted participants, intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Mean Value of Lipid Parameters | non-HDL Cholesterol; Month 24 (n=166, 190, 181) | 145.1 mg/dL | Standard Deviation 39.52 |
| Cyclosporine | Mean Value of Lipid Parameters | HDL Cholesterol; Month 12 (n=189, 195, 192) | 47.4 mg/dL | Standard Deviation 13.33 |
| Cyclosporine | Mean Value of Lipid Parameters | non-HDL Cholesterol; Month 36 (n=154, 184, 176) | 142.2 mg/dL | Standard Deviation 43.19 |
| Cyclosporine | Mean Value of Lipid Parameters | Total Cholesterol; Month 24 (n=166, 190, 181) | 193.5 mg/dL | Standard Deviation 40.23 |
| Cyclosporine | Mean Value of Lipid Parameters | Total Cholesterol; Month 12 (n=189, 195, 192) | 191.5 mg/dL | Standard Deviation 49.29 |
| Cyclosporine | Mean Value of Lipid Parameters | Triglyceride; Month 24 (n=164, 186, 168) | 179.5 mg/dL | Standard Deviation 97.51 |
| Cyclosporine | Mean Value of Lipid Parameters | HDL ; Month 24 (n=166, 190, 181) | 48.4 mg/dL | Standard Deviation 13.74 |
| Cyclosporine | Mean Value of Lipid Parameters | HDL Cholesterol; Month 36 (n=154, 184, 176) | 48.5 mg/dL | Standard Deviation 14.27 |
| Cyclosporine | Mean Value of Lipid Parameters | LDL Cholesterol; Month 24 (n=164, 186, 168) | 109.1 mg/dL | Standard Deviation 35.92 |
| Cyclosporine | Mean Value of Lipid Parameters | LDL Cholesterol; Month 12 (n=187, 186, 183) | 107.3 mg/dL | Standard Deviation 39.6 |
| Cyclosporine | Mean Value of Lipid Parameters | Triglyceride; Month 36 (n=142, 170, 161) | 179.1 mg/dL | Standard Deviation 97.07 |
| Cyclosporine | Mean Value of Lipid Parameters | non-HDL Cholesterol; Month 12 (n=189, 195, 192) | 144.1 mg/dL | Standard Deviation 47.31 |
| Cyclosporine | Mean Value of Lipid Parameters | Triglyceride; Month 12 (n=187, 186, 183) | 184.6 mg/dL | Standard Deviation 106.42 |
| Cyclosporine | Mean Value of Lipid Parameters | LDL Cholesterol; Month 36 (n=142, 170, 161) | 107.6 mg/dL | Standard Deviation 37.66 |
| Cyclosporine | Mean Value of Lipid Parameters | Total Cholesterol; Month 36 (n=154, 184, 176) | 190.7 mg/dL | Standard Deviation 45.28 |
| Belatacept LI | Mean Value of Lipid Parameters | Total Cholesterol; Month 36 (n=154, 184, 176) | 171.3 mg/dL | Standard Deviation 45.78 |
| Belatacept LI | Mean Value of Lipid Parameters | non-HDL Cholesterol; Month 12 (n=189, 195, 192) | 131.5 mg/dL | Standard Deviation 38.18 |
| Belatacept LI | Mean Value of Lipid Parameters | Total Cholesterol; Month 12 (n=189, 195, 192) | 182.4 mg/dL | Standard Deviation 39.78 |
| Belatacept LI | Mean Value of Lipid Parameters | HDL Cholesterol; Month 12 (n=189, 195, 192) | 50.8 mg/dL | Standard Deviation 15.98 |
| Belatacept LI | Mean Value of Lipid Parameters | LDL Cholesterol; Month 12 (n=187, 186, 183) | 102.1 mg/dL | Standard Deviation 33.4 |
| Belatacept LI | Mean Value of Lipid Parameters | Triglyceride; Month 12 (n=187, 186, 183) | 149.4 mg/dL | Standard Deviation 87.25 |
| Belatacept LI | Mean Value of Lipid Parameters | non-HDL Cholesterol; Month 24 (n=166, 190, 181) | 126.7 mg/dL | Standard Deviation 38.48 |
| Belatacept LI | Mean Value of Lipid Parameters | Total Cholesterol; Month 24 (n=166, 190, 181) | 175.3 mg/dL | Standard Deviation 42.38 |
| Belatacept LI | Mean Value of Lipid Parameters | HDL ; Month 24 (n=166, 190, 181) | 48.6 mg/dL | Standard Deviation 15.28 |
| Belatacept LI | Mean Value of Lipid Parameters | LDL Cholesterol; Month 24 (n=164, 186, 168) | 98.6 mg/dL | Standard Deviation 33.71 |
| Belatacept LI | Mean Value of Lipid Parameters | Triglyceride; Month 24 (n=164, 186, 168) | 143.4 mg/dL | Standard Deviation 88.97 |
| Belatacept LI | Mean Value of Lipid Parameters | non-HDL Cholesterol; Month 36 (n=154, 184, 176) | 122.4 mg/dL | Standard Deviation 40.12 |
| Belatacept LI | Mean Value of Lipid Parameters | HDL Cholesterol; Month 36 (n=154, 184, 176) | 48.9 mg/dL | Standard Deviation 15.37 |
| Belatacept LI | Mean Value of Lipid Parameters | LDL Cholesterol; Month 36 (n=142, 170, 161) | 96.7 mg/dL | Standard Deviation 36.53 |
| Belatacept LI | Mean Value of Lipid Parameters | Triglyceride; Month 36 (n=142, 170, 161) | 132.7 mg/dL | Standard Deviation 68.69 |
| Belatacept MI | Mean Value of Lipid Parameters | non-HDL Cholesterol; Month 24 (n=166, 190, 181) | 127.0 mg/dL | Standard Deviation 36.76 |
| Belatacept MI | Mean Value of Lipid Parameters | LDL Cholesterol; Month 36 (n=142, 170, 161) | 92.5 mg/dL | Standard Deviation 33.78 |
| Belatacept MI | Mean Value of Lipid Parameters | non-HDL Cholesterol; Month 36 (n=154, 184, 176) | 122.1 mg/dL | Standard Deviation 38.78 |
| Belatacept MI | Mean Value of Lipid Parameters | Triglyceride; Month 12 (n=187, 186, 183) | 155.0 mg/dL | Standard Deviation 85.08 |
| Belatacept MI | Mean Value of Lipid Parameters | LDL Cholesterol; Month 12 (n=187, 186, 183) | 100.8 mg/dL | Standard Deviation 29.48 |
| Belatacept MI | Mean Value of Lipid Parameters | Total Cholesterol; Month 36 (n=154, 184, 176) | 170.7 mg/dL | Standard Deviation 43.26 |
| Belatacept MI | Mean Value of Lipid Parameters | HDL Cholesterol; Month 12 (n=189, 195, 192) | 49.7 mg/dL | Standard Deviation 15.69 |
| Belatacept MI | Mean Value of Lipid Parameters | non-HDL Cholesterol; Month 12 (n=189, 195, 192) | 131.7 mg/dL | Standard Deviation 36.76 |
| Belatacept MI | Mean Value of Lipid Parameters | HDL Cholesterol; Month 36 (n=154, 184, 176) | 48.6 mg/dL | Standard Deviation 16.86 |
| Belatacept MI | Mean Value of Lipid Parameters | HDL ; Month 24 (n=166, 190, 181) | 48.5 mg/dL | Standard Deviation 14.92 |
| Belatacept MI | Mean Value of Lipid Parameters | Total Cholesterol; Month 12 (n=189, 195, 192) | 181.3 mg/dL | Standard Deviation 39.92 |
| Belatacept MI | Mean Value of Lipid Parameters | LDL Cholesterol; Month 24 (n=164, 186, 168) | 96.5 mg/dL | Standard Deviation 30.52 |
| Belatacept MI | Mean Value of Lipid Parameters | Total Cholesterol; Month 24 (n=166, 190, 181) | 175.4 mg/dL | Standard Deviation 40.03 |
| Belatacept MI | Mean Value of Lipid Parameters | Triglyceride; Month 36 (n=142, 170, 161) | 144.0 mg/dL | Standard Deviation 81.48 |
| Belatacept MI | Mean Value of Lipid Parameters | Triglyceride; Month 24 (n=164, 186, 168) | 151.2 mg/dL | Standard Deviation 95.88 |
Secondary
Mean Value of Physical and Mental Components Using SF-36 Questionnaire
SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.
Time frame: Months 6, 12, 24, 36
Population: All randomized and transplanted participants, intent to treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Mental Component Score; Month 6 (n=191, 205, 189) | 49.4 units on a scale | Standard Deviation 11.08 |
| Cyclosporine | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Physical Component Score; Month 6 (n=191,205,189) | 47.3 units on a scale | Standard Deviation 8.91 |
| Cyclosporine | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Mental Component Score; Month 12 (n=198,210,194) | 49.5 units on a scale | Standard Deviation 10.78 |
| Cyclosporine | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Physical Component Score; Month 12 (n=198,210,194) | 47.5 units on a scale | Standard Deviation 9.34 |
| Cyclosporine | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Mental Component Score; Month 24 (n=200,214,198) | 48.3 units on a scale | Standard Deviation 11.14 |
| Cyclosporine | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Physical Component Score; Month 24 (n=200,214,198) | 47.3 units on a scale | Standard Deviation 9.5 |
| Cyclosporine | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Mental Component Score; Month 36 (n=203,218,201) | 46.9 units on a scale | Standard Deviation 11.6 |
| Cyclosporine | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Physical Component Score; Month 36 (n=203,218,201) | 47.1 units on a scale | Standard Deviation 9.47 |
| Belatacept LI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Mental Component Score; Month 12 (n=198,210,194) | 50.3 units on a scale | Standard Deviation 10.08 |
| Belatacept LI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Mental Component Score; Month 36 (n=203,218,201) | 48.7 units on a scale | Standard Deviation 11.26 |
| Belatacept LI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Physical Component Score; Month 12 (n=198,210,194) | 49.6 units on a scale | Standard Deviation 8.18 |
| Belatacept LI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Mental Component Score; Month 24 (n=200,214,198) | 49.6 units on a scale | Standard Deviation 10.77 |
| Belatacept LI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Physical Component Score; Month 24 (n=200,214,198) | 49.0 units on a scale | Standard Deviation 8.77 |
| Belatacept LI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Mental Component Score; Month 6 (n=191, 205, 189) | 49.9 units on a scale | Standard Deviation 10.55 |
| Belatacept LI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Physical Component Score; Month 6 (n=191,205,189) | 48.9 units on a scale | Standard Deviation 8.59 |
| Belatacept LI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Physical Component Score; Month 36 (n=203,218,201) | 49.2 units on a scale | Standard Deviation 9.15 |
| Belatacept MI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Mental Component Score; Month 12 (n=198,210,194) | 49.9 units on a scale | Standard Deviation 10.54 |
| Belatacept MI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Physical Component Score; Month 6 (n=191,205,189) | 49.2 units on a scale | Standard Deviation 7.58 |
| Belatacept MI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Mental Component Score; Month 6 (n=191, 205, 189) | 51.1 units on a scale | Standard Deviation 10.53 |
| Belatacept MI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Physical Component Score; Month 12 (n=198,210,194) | 50.3 units on a scale | Standard Deviation 8.21 |
| Belatacept MI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Mental Component Score; Month 36 (n=203,218,201) | 48.3 units on a scale | Standard Deviation 11.5 |
| Belatacept MI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Physical Component Score; Month 24 (n=200,214,198) | 49.9 units on a scale | Standard Deviation 8.03 |
| Belatacept MI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Mental Component Score; Month 24 (n=200,214,198) | 48.8 units on a scale | Standard Deviation 11.03 |
| Belatacept MI | Mean Value of Physical and Mental Components Using SF-36 Questionnaire | Physical Component Score; Month 36 (n=203,218,201) | 48.7 units on a scale | Standard Deviation 8.9 |
Comparison: Mental Component Score; Month 36p-value: 0.095395% CI: [-0.3, 4.1]ANOVA
Comparison: Mental Component Score; Month 36p-value: 0.196195% CI: [-0.8, 3.7]ANOVA
Comparison: Physical Component Score; Month 36p-value: 0.019195% CI: [0.3, 3.9]ANOVA
Comparison: Mental Component Score; Month 6p-value: 0.657395% CI: [-1.6, 2.6]ANOVA
Comparison: Mental Component Score; Month 6p-value: 0.119895% CI: [-0.4, 3.9]ANOVA
Comparison: Physical Component Score; Month 6p-value: 0.067295% CI: [-0.1, 3.2]ANOVA
Comparison: Physical Component Score; Month 6p-value: 0.025795% CI: [0.2, 3.6]ANOVA
Comparison: Mental Component Score; Month 12p-value: 0.414695% CI: [-1.2, 2.9]ANOVA
Comparison: Mental Component Score; Month 12p-value: 0.732795% CI: [-1.7, 2.4]ANOVA
Comparison: Physical Component Score; Month 12p-value: 0.014495% CI: [0.4, 3.8]ANOVA
Comparison: Physical Component Score; Month 12p-value: 0.001595% CI: [1.1, 4.5]ANOVA
Comparison: Mental Component Score; Month 24p-value: 0.23495% CI: [-0.8, 3.4]ANOVA
Comparison: Mental Component Score; Month 24p-value: 0.663595% CI: [-1.7, 2.6]ANOVA
Comparison: Physical Component Score; Month 24p-value: 0.041795% CI: [0.1, 3.5]ANOVA
Comparison: Physical Component Score; Month 24p-value: 0.002695% CI: [0.9, 4.4]ANOVA
Comparison: Physical Component Score; Month 36p-value: 0.068495% CI: [-0.1, 3.5]ANOVA
Secondary
Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation
Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x \[SCr/0.95\]\^(-0.999) x \[Age\]\^(-0.176) x \[0.762 if participant is female\] x \[1.180 if participant is black\] x \[BUN\]\^(-0.170) x \[Alb\]\^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m2
Time frame: Months 6, 12, 24, 36
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation | Month 6 (n=189, 185, 170) | 48.8 mL/min/1.73 m^2 | Standard Deviation 19.22 |
| Cyclosporine | Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation | Month 12 (n=199, 200, 201) | 50.1 mL/min/1.73 m^2 | Standard Deviation 21.06 |
| Cyclosporine | Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation | Month 24 (n=182, 201, 191) | 47.9 mL/min/1.73 m^2 | Standard Deviation 23 |
| Cyclosporine | Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation | Month 36 (n=171, 190, 186) | 44.4 mL/min/1.73 m^2 | Standard Deviation 23.58 |
| Belatacept LI | Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation | Month 36 (n=171, 190, 186) | 65.8 mL/min/1.73 m^2 | Standard Deviation 27 |
| Belatacept LI | Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation | Month 6 (n=189, 185, 170) | 62.6 mL/min/1.73 m^2 | Standard Deviation 20.41 |
| Belatacept LI | Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation | Month 24 (n=182, 201, 191) | 65.4 mL/min/1.73 m^2 | Standard Deviation 25.22 |
| Belatacept LI | Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation | Month 12 (n=199, 200, 201) | 65.4 mL/min/1.73 m^2 | Standard Deviation 22.94 |
| Belatacept MI | Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation | Month 36 (n=171, 190, 186) | 65.2 mL/min/1.73 m^2 | Standard Deviation 26.31 |
| Belatacept MI | Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation | Month 12 (n=199, 200, 201) | 65.2 mL/min/1.73 m^2 | Standard Deviation 23.51 |
| Belatacept MI | Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation | Month 24 (n=182, 201, 191) | 65.5 mL/min/1.73 m^2 | Standard Deviation 24.87 |
| Belatacept MI | Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation | Month 6 (n=189, 185, 170) | 62.4 mL/min/1.73 m^2 | Standard Deviation 20.94 |
Comparison: Month 1297.3% CI: [10.3, 20.3]
Comparison: Month 1297.3% CI: [10.1, 20.1]
Comparison: Month 2497.3% CI: [12, 23.1]
Comparison: Month 2497.3% CI: [12, 23.3]
Comparison: Month 3697.3% CI: [15.4, 27.4]
Comparison: Month 3697.3% CI: [14.8, 26.9]
Secondary
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire
SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.
Time frame: Months 6, 12, 24, 36
Population: All randomized and transplanted participants, intent to treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Bodily Pain, Month 12 (n=200, 213, 199) | 50.8 units on a scale | Standard Deviation 10.79 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | General Health, Month 6 (n=193, 207, 194) | 47.9 units on a scale | Standard Deviation 10.08 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Mental Health, Month 6 (n=192, 206, 194) | 50.1 units on a scale | Standard Deviation 11.08 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Physical Functioning, Month 6 (n=193, 207, 194) | 47.4 units on a scale | Standard Deviation 9.13 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role Emotional, Month 6 (n=192, 206, 191) | 44.6 units on a scale | Standard Deviation 12.31 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role-Physical, Month 6 (n=192, 207, 192) | 43.2 units on a scale | Standard Deviation 11.08 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Social Functioning, Month 6 (n=193, 207, 194) | 47.5 units on a scale | Standard Deviation 10.68 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Vitality, Month 6 (n=192, 206, 194) | 54.0 units on a scale | Standard Deviation 10.27 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Bodily Pain, Month 6 (n=193, 207, 193) | 50.6 units on a scale | Standard Deviation 10.96 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | General Health, Month 12 (n=200, 214, 199) | 46.9 units on a scale | Standard Deviation 9.98 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Mental Health, Month 12 (n=200, 213, 199) | 49.8 units on a scale | Standard Deviation 10.99 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Physical Functioning, Month 12 (n=200, 214, 198) | 47.2 units on a scale | Standard Deviation 9.77 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role Emotional, Month 12 (n=198, 213, 196) | 45.8 units on a scale | Standard Deviation 11.36 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role-Physical, Month 12 (n=199, 213, 196) | 45.0 units on a scale | Standard Deviation 10.78 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Social Functioning, Month 12 (n=200, 213, 199) | 47.6 units on a scale | Standard Deviation 10.26 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Vitality, Month 12 (n=200, 213, 199) | 53.3 units on a scale | Standard Deviation 10.01 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Bodily Pain, Month 24 (n=203, 219, 205) | 51.0 units on a scale | Standard Deviation 10.82 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | General Health, Month 24 (n=203, 219, 205) | 46.2 units on a scale | Standard Deviation 10.07 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Mental Health, Month 24 (n=201, 215, 199) | 48.5 units on a scale | Standard Deviation 11.13 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Physical Functioning, Month 24 (n=203, 219, 205) | 46.5 units on a scale | Standard Deviation 10.69 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role Emotional, Month 24 (n=202, 218, 205) | 44.8 units on a scale | Standard Deviation 12.54 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role-Physical, Month 24 (n=203, 219, 204) | 44.1 units on a scale | Standard Deviation 11.61 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Social Functioning, Month 24 (n=203, 219, 205) | 47.3 units on a scale | Standard Deviation 10.64 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Vitality, Month 24 (n=201, 215, 200) | 52.5 units on a scale | Standard Deviation 10.58 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Bodily Pain, Month 36 (n=204, 219, 205) | 50.0 units on a scale | Standard Deviation 11.4 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | General Health, Month 36 (n=205, 219, 206) | 45.5 units on a scale | Standard Deviation 10.12 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Mental Health, Month 36 (n=203, 219, 204) | 47.4 units on a scale | Standard Deviation 11.64 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Physical Functioning, Month 36 (n=204, 218, 206) | 46.8 units on a scale | Standard Deviation 9.92 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role Emotional, Month 36 (n=204, 219, 205) | 43.5 units on a scale | Standard Deviation 12.18 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role-Physical, Month 36 (n=204, 219, 205) | 43.6 units on a scale | Standard Deviation 10.73 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Social Functioning, Month 36 (n=204, 219, 206) | 46.6 units on a scale | Standard Deviation 10.68 |
| Cyclosporine | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Vitality, Month 36 (n=203, 219, 204) | 51.4 units on a scale | Standard Deviation 10.48 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role-Physical, Month 24 (n=203, 219, 204) | 46.6 units on a scale | Standard Deviation 10.39 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Bodily Pain, Month 6 (n=193, 207, 193) | 52.5 units on a scale | Standard Deviation 10.1 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role-Physical, Month 12 (n=199, 213, 196) | 47.1 units on a scale | Standard Deviation 10 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Bodily Pain, Month 24 (n=203, 219, 205) | 51.4 units on a scale | Standard Deviation 10.51 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | General Health, Month 6 (n=193, 207, 194) | 48.2 units on a scale | Standard Deviation 9.67 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role Emotional, Month 12 (n=198, 213, 196) | 46.8 units on a scale | Standard Deviation 10.82 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Social Functioning, Month 36 (n=204, 219, 206) | 48.1 units on a scale | Standard Deviation 10.28 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Mental Health, Month 6 (n=192, 206, 194) | 50.3 units on a scale | Standard Deviation 10.33 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | General Health, Month 24 (n=203, 219, 205) | 48.4 units on a scale | Standard Deviation 9.61 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Social Functioning, Month 24 (n=203, 219, 205) | 48.6 units on a scale | Standard Deviation 10.28 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Physical Functioning, Month 6 (n=193, 207, 194) | 48.3 units on a scale | Standard Deviation 9.01 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Vitality, Month 36 (n=203, 219, 204) | 53.6 units on a scale | Standard Deviation 11.38 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Physical Functioning, Month 36 (n=204, 218, 206) | 48.1 units on a scale | Standard Deviation 10.22 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role Emotional, Month 6 (n=192, 206, 191) | 46.0 units on a scale | Standard Deviation 11.19 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Mental Health, Month 24 (n=201, 215, 199) | 49.7 units on a scale | Standard Deviation 10.89 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Social Functioning, Month 12 (n=200, 213, 199) | 48.4 units on a scale | Standard Deviation 9.61 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role-Physical, Month 6 (n=192, 207, 192) | 45.2 units on a scale | Standard Deviation 10.34 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Physical Functioning, Month 12 (n=200, 214, 198) | 49.0 units on a scale | Standard Deviation 8.88 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Vitality, Month 24 (n=201, 215, 200) | 54.5 units on a scale | Standard Deviation 10.3 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Social Functioning, Month 6 (n=193, 207, 194) | 47.8 units on a scale | Standard Deviation 10.41 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Physical Functioning, Month 24 (n=203, 219, 205) | 48.7 units on a scale | Standard Deviation 9.76 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Mental Health, Month 36 (n=203, 219, 204) | 48.9 units on a scale | Standard Deviation 11.52 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Vitality, Month 6 (n=192, 206, 194) | 55.5 units on a scale | Standard Deviation 9.75 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Vitality, Month 12 (n=200, 213, 199) | 55.7 units on a scale | Standard Deviation 9.81 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role-Physical, Month 36 (n=204, 219, 205) | 46.3 units on a scale | Standard Deviation 11.03 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Bodily Pain, Month 12 (n=200, 213, 199) | 52.7 units on a scale | Standard Deviation 9.67 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role Emotional, Month 24 (n=202, 218, 205) | 46.4 units on a scale | Standard Deviation 10.89 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Bodily Pain, Month 36 (n=204, 219, 205) | 52.3 units on a scale | Standard Deviation 10.4 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | General Health, Month 12 (n=200, 214, 199) | 48.8 units on a scale | Standard Deviation 9.57 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | General Health, Month 36 (n=205, 219, 206) | 47.7 units on a scale | Standard Deviation 10.45 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role Emotional, Month 36 (n=204, 219, 205) | 46.0 units on a scale | Standard Deviation 11.85 |
| Belatacept LI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Mental Health, Month 12 (n=200, 213, 199) | 50.7 units on a scale | Standard Deviation 10.64 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Vitality, Month 6 (n=192, 206, 194) | 56.2 units on a scale | Standard Deviation 9.29 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role-Physical, Month 36 (n=204, 219, 205) | 46.2 units on a scale | Standard Deviation 10.03 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Physical Functioning, Month 12 (n=200, 214, 198) | 48.1 units on a scale | Standard Deviation 9.84 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role Emotional, Month 12 (n=198, 213, 196) | 45.9 units on a scale | Standard Deviation 11.27 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | General Health, Month 36 (n=205, 219, 206) | 47.5 units on a scale | Standard Deviation 9.93 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role-Physical, Month 12 (n=199, 213, 196) | 47.5 units on a scale | Standard Deviation 9.9 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Social Functioning, Month 12 (n=200, 213, 199) | 49.1 units on a scale | Standard Deviation 9.8 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Vitality, Month 12 (n=200, 213, 199) | 56.0 units on a scale | Standard Deviation 9.34 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Mental Health, Month 36 (n=203, 219, 204) | 48.7 units on a scale | Standard Deviation 11.43 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Bodily Pain, Month 24 (n=203, 219, 205) | 52.5 units on a scale | Standard Deviation 10.47 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | General Health, Month 24 (n=203, 219, 205) | 48.7 units on a scale | Standard Deviation 9.45 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Mental Health, Month 24 (n=201, 215, 199) | 49.3 units on a scale | Standard Deviation 10.85 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Physical Functioning, Month 36 (n=204, 218, 206) | 47.8 units on a scale | Standard Deviation 10.12 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Physical Functioning, Month 24 (n=203, 219, 205) | 48.0 units on a scale | Standard Deviation 10.24 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Social Functioning, Month 36 (n=204, 219, 206) | 47.1 units on a scale | Standard Deviation 10.66 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role Emotional, Month 24 (n=202, 218, 205) | 46.0 units on a scale | Standard Deviation 10.88 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Bodily Pain, Month 6 (n=193, 207, 193) | 52.7 units on a scale | Standard Deviation 10.04 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role-Physical, Month 24 (n=203, 219, 204) | 48.0 units on a scale | Standard Deviation 9.33 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | General Health, Month 6 (n=193, 207, 194) | 49.0 units on a scale | Standard Deviation 8.66 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role Emotional, Month 36 (n=204, 219, 205) | 45.3 units on a scale | Standard Deviation 11.67 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Mental Health, Month 6 (n=192, 206, 194) | 51.3 units on a scale | Standard Deviation 10.78 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Physical Functioning, Month 6 (n=193, 207, 194) | 48.0 units on a scale | Standard Deviation 8.81 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Social Functioning, Month 24 (n=203, 219, 205) | 47.7 units on a scale | Standard Deviation 10.23 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role Emotional, Month 6 (n=192, 206, 191) | 46.8 units on a scale | Standard Deviation 10.55 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Vitality, Month 36 (n=203, 219, 204) | 53.4 units on a scale | Standard Deviation 10.46 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Role-Physical, Month 6 (n=192, 207, 192) | 46.7 units on a scale | Standard Deviation 9.06 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Social Functioning, Month 6 (n=193, 207, 194) | 47.9 units on a scale | Standard Deviation 10.65 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Vitality, Month 24 (n=201, 215, 200) | 54.2 units on a scale | Standard Deviation 10.3 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Mental Health, Month 12 (n=200, 213, 199) | 50.3 units on a scale | Standard Deviation 10.29 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Bodily Pain, Month 12 (n=200, 213, 199) | 53.7 units on a scale | Standard Deviation 9.6 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | General Health, Month 12 (n=200, 214, 199) | 49.2 units on a scale | Standard Deviation 8.85 |
| Belatacept MI | Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire | Bodily Pain, Month 36 (n=204, 219, 205) | 51.0 units on a scale | Standard Deviation 11.05 |
Comparison: Bodily Pain, Month 6p-value: 0.071495% CI: [-0.2, 3.9]ANOVA
Comparison: Bodily Pain, Month 6p-value: 0.053695% CI: [0, 4.1]ANOVA
Comparison: General Health, Month 6p-value: 0.754395% CI: [-1.6, 2.2]ANOVA
Comparison: General Health, Month 6p-value: 0.249995% CI: [-0.8, 3]ANOVA
Comparison: Mental Health, Month 6p-value: 0.833295% CI: [-1.9, 2.3]ANOVA
Comparison: Mental Health, Month 6p-value: 0.252395% CI: [-0.9, 3.4]ANOVA
Comparison: Physical Functioning, Month 6p-value: 0.301895% CI: [-0.8, 2.7]ANOVA
Comparison: Physical Functioning, Month 6p-value: 0.543795% CI: [-1.2, 2.3]ANOVA
Comparison: Role Emotional, Month 6p-value: 0.23795% CI: [-0.9, 3.6]ANOVA
Comparison: Role Emotional, Month 6p-value: 0.058895% CI: [-0.1, 4.5]ANOVA
Comparison: Role Physical, Month 6p-value: 0.050295% CI: [0, 4]ANOVA
Comparison: Role-Physical, Month 6p-value: 0.000795% CI: [1.5, 5.6]ANOVA
Comparison: Social Functioning, Month 6p-value: 0.763795% CI: [-1.8, 2.4]ANOVA
Comparison: Social Functioning, Month 6p-value: 0.700695% CI: [-1.7, 2.5]ANOVA
Comparison: Vitality, Month 6p-value: 0.122295% CI: [-0.4, 3.4]ANOVA
Comparison: Vitality, Month 6p-value: 0.028995% CI: [0.2, 4.1]ANOVA
Comparison: Bodily Pain, Month 12p-value: 0.057195% CI: [-0.1, 3.8]ANOVA
Comparison: Bodily Pain, Month 12p-value: 0.004295% CI: [0.9, 4.9]ANOVA
Comparison: General Health, Month 12p-value: 0.042395% CI: [0.1, 3.7]ANOVA
Comparison: General Health, Month 12p-value: 0.017495% CI: [0.4, 4.1]ANOVA
Comparison: Mental Health, Month 12p-value: 0.36395% CI: [-1.1, 3]ANOVA
Comparison: Mental Health, Month 12p-value: 0.631995% CI: [-1.6, 2.6]ANOVA
Comparison: Physical Functioning, Month 12p-value: 0.050395% CI: [0, 3.7]ANOVA
Comparison: Physical Functioning, Month 12p-value: 0.329195% CI: [-0.9, 2.8]ANOVA
Comparison: Role Emotional, Month 12p-value: 0.38695% CI: [-1.2, 3.1]ANOVA
Comparison: Vitality, Month 36p-value: 0.052595% CI: [0, 4.2]ANOVA
Comparison: Role Emotional, Month 12p-value: 0.967295% CI: [-2.2, 2.3]ANOVA
Comparison: Role-Physical, Month 12p-value: 0.039295% CI: [0.1, 4.1]ANOVA
Comparison: Role-Physical, Month 12p-value: 0.015195% CI: [0.5, 4.5]ANOVA
Comparison: Social Functioning, Month 12p-value: 0.397895% CI: [-1.1, 2.7]ANOVA
Comparison: Social Functioning, Month 12p-value: 0.126395% CI: [-0.4, 3.5]ANOVA
Comparison: Vitality, Month 12p-value: 0.01695% CI: [0.4, 4.2]ANOVA
Comparison: Vitality, Month 12p-value: 0.007595% CI: [0.7, 4.5]ANOVA
Comparison: Bodily Pain, Month 24p-value: 0.69995% CI: [-1.6, 2.4]ANOVA
Comparison: Bodily Pain, Month 24p-value: 0.160895% CI: [-0.6, 3.5]ANOVA
Comparison: General Health, Month 24p-value: 0.021495% CI: [0.3, 4]ANOVA
Comparison: General Health, Month 24p-value: 0.0088695% CI: [0.6, 4.4]ANOVA
Comparison: Mental Health, Month 24p-value: 0.255595% CI: [-0.9, 3.3]ANOVA
Comparison: Mental Health, Month 24p-value: 0.480495% CI: [-1.4, 2.9]ANOVA
Comparison: Physical Functioning, Month 24p-value: 0.027695% CI: [0.2, 4.2]ANOVA
Comparison: Physical Functioning, Month 24p-value: 0.128595% CI: [-0.4, 3.5]ANOVA
Comparison: Role Emotional, Month 24p-value: 0.135295% CI: [-0.5, 3.9]ANOVA
Comparison: Role Emotional, Month 24p-value: 0.266395% CI: [-1, 3.5]ANOVA
Comparison: Role-Physical, Month 24p-value: 0.016495% CI: [0.5, 4.5]ANOVA
Comparison: Role-Physical, Month 24p-value: 0.000295% CI: [1.9, 5.9]ANOVA
Comparison: Social Functioning, Month 24p-value: 0.191495% CI: [-0.7, 3.3]ANOVA
Comparison: Social Functioning, Month 24p-value: 0.688295% CI: [-1.6, 2.4]ANOVA
Comparison: Vitality, Month 24p-value: 0.054795% CI: [0, 4]ANOVA
Comparison: Vitality, Month 24p-value: 0.099295% CI: [-0.3, 3.8]ANOVA
Comparison: Bodily Pain, Month 36p-value: 0.033995% CI: [0.2, 4.4]ANOVA
Comparison: Bodily Pain, Month 36p-value: 0.357295% CI: [-1.1, 3.1]ANOVA
Comparison: General Health, Month 36p-value: 0.021195% CI: [0.3, 4.2]ANOVA
Comparison: General Health, Month 36p-value: 0.04595% CI: [0, 4]ANOVA
Comparison: Mental Health, Month 36p-value: 0.17195% CI: [-0.7, 3.7]ANOVA
Comparison: Mental Health, Month 36p-value: 0.248495% CI: [-0.9, 3.6]ANOVA
Comparison: Physical Functioning, Month 36p-value: 0.183695% CI: [-0.6, 3.2]ANOVA
Comparison: Physical Functioning, Month 36p-value: 0.330395% CI: [-1, 2.9]ANOVA
Comparison: Role Emotional, Month 36p-value: 0.029995% CI: [0.2, 4.8]ANOVA
Comparison: Role Emotional, Month 36p-value: 0.114195% CI: [-0.4, 4.2]ANOVA
Comparison: Role-Physical, Month 36p-value: 0.008795% CI: [0.7, 4.7]ANOVA
Comparison: Role-Physical, Month 36p-value: 0.012895% CI: [0.6, 4.7]ANOVA
Comparison: Social Functioning, Month 36p-value: 0.136995% CI: [-0.5, 3.5]ANOVA
Comparison: Social Functioning, Month 36p-value: 0.633195% CI: [-1.5, 2.5]ANOVA
Comparison: Vitality, Month 36p-value: 0.036195% CI: [0.1, 4.3]ANOVA
Secondary
Mean Value of the Measured Glomerular Filtration Rate (mGFR)
Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m\^2.
Time frame: Months 3, 12, 24
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Mean Value of the Measured Glomerular Filtration Rate (mGFR) | Month 12 (n=199, 206, 200) | 50.4 mL/min/1.73m^2 | Standard Deviation 18.71 |
| Cyclosporine | Mean Value of the Measured Glomerular Filtration Rate (mGFR) | Month 3 (n=201, 215, 209) | 51.9 mL/min/1.73m^2 | Standard Deviation 21.09 |
| Cyclosporine | Mean Value of the Measured Glomerular Filtration Rate (mGFR) | Month 24 (n=185, 199, 192) | 50.5 mL/min/1.73m^2 | Standard Deviation 20.52 |
| Belatacept LI | Mean Value of the Measured Glomerular Filtration Rate (mGFR) | Month 12 (n=199, 206, 200) | 63.4 mL/min/1.73m^2 | Standard Deviation 27.66 |
| Belatacept LI | Mean Value of the Measured Glomerular Filtration Rate (mGFR) | Month 3 (n=201, 215, 209) | 61.7 mL/min/1.73m^2 | Standard Deviation 25.43 |
| Belatacept LI | Mean Value of the Measured Glomerular Filtration Rate (mGFR) | Month 24 (n=185, 199, 192) | 67.9 mL/min/1.73m^2 | Standard Deviation 29.9 |
| Belatacept MI | Mean Value of the Measured Glomerular Filtration Rate (mGFR) | Month 3 (n=201, 215, 209) | 59.9 mL/min/1.73m^2 | Standard Deviation 28.47 |
| Belatacept MI | Mean Value of the Measured Glomerular Filtration Rate (mGFR) | Month 24 (n=185, 199, 192) | 65.0 mL/min/1.73m^2 | Standard Deviation 27.21 |
| Belatacept MI | Mean Value of the Measured Glomerular Filtration Rate (mGFR) | Month 12 (n=199, 206, 200) | 65.0 mL/min/1.73m^2 | Standard Deviation 30.02 |
Comparison: Time Frame = Day 1 to Month 12p-value: <0.000197.3% CI: [7.3, 18.7]Kruskal-Wallis
Comparison: Time Frame = Day 1 to Month 12p-value: <0.000197.3% CI: [8.9, 20.4]Kruskal-Wallis
Comparison: Time Frame = Day 1 to Month 24p-value: <0.000197.3% CI: [11.5, 23.4]Kruskal-Wallis
Comparison: Time Frame = Day 1 to Month 24p-value: <0.000197.3% CI: [8.5, 20.5]Kruskal-Wallis
Secondary
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36
Upper limit of normal (ULN). Units per Liter (U/L). Cells per microliter (c/µL). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).Cells per Liter (c/L). Milliequivalents/Liter (mEq/L). Hemoglobin (low): \<8.0 g/dL; Platelet count: \<50\*10\^9 c/L; Leukocytes: \<2\*10\^3 c/µL; Alkaline phosphatase (ALP): \>5.0\*ULN U/L; Alanine aminotransferase (ALT): \>5.0\*ULN U/L; Asparate aminotransferase (AST): \>5.0\*ULN U/L; Bilirubin Total: \>3.0\*ULN mg/dL; Creatinine: \>3.0\*ULN mg/dL; Calcium Total: low if \<7.0 mg/dL or high if \>12.5 mg/dL; Bicarbonate: \<11.0 mEq/L; Potassium serum: low if \<3.0 mEq/L or high if \>6.0 mEq/L; Magnesium serum: low is \<0.8 mEq/L or high if \>2.46 mEq/L; Sodium serum: low if \<130.0 mEq/L or high if \>155.0 mEq/L; Phosphorus inorganic: \<2.0 mg/dL; Albumin: \<2 g/dL; Uric acid: \>10 mg/dL; Protein urine: \>=3+
Time frame: Baseline to Month 36
Population: All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Alanine aminotransferase, high (n=214, 226, 219) | 6 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Hemoglobin, low (n=213, 226, 219) | 26 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Magnessium serum, high (n=214, 225, 219) | 9 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Bicarbonate, low (n=214, 226, 219) | 1 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Protein in urine, high (n=213, 224, 217) | 33 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Sodium serum, low (n=214, 226, 219) | 21 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Bilirubin total, high (n=214, 226, 219) | 1 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Uric acid, high (n=214, 226, 219) | 42 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Sodium serum, high (n=214, 226, 219) | 0 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Alkaline phosphatase, high (n=214, 226, 219) | 1 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Albumin, low (n=214, 226, 219) | 0 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Phosphorus inorganic, low (n=213, 224, 219) | 75 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Bicarbonate, high (n=214, 226, 219) | 0 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Aspartate aminotransferase, high (n=214, 226, 219) | 2 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Leukocytes, low (n=213, 226, 219) | 10 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Potassium serum, low (n=213, 223, 219) | 4 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Calcium total, high (n=214, 226, 219) | 0 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Creatinine, high (n=213, 223, 219) | 48 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Potassium serum, high (n=213, 223, 219) | 13 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Calcium total, low (n=214, 226, 219) | 7 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Platelet count, low (n=213, 226, 218) | 0 participants |
| Cyclosporine | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Magnessium serum, low (n=214, 225, 219) | 1 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Platelet count, low (n=213, 226, 218) | 1 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Creatinine, high (n=213, 223, 219) | 50 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Calcium total, low (n=214, 226, 219) | 8 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Calcium total, high (n=214, 226, 219) | 1 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Bicarbonate, low (n=214, 226, 219) | 0 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Bicarbonate, high (n=214, 226, 219) | 0 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Potassium serum, low (n=213, 223, 219) | 13 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Potassium serum, high (n=213, 223, 219) | 9 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Magnessium serum, low (n=214, 225, 219) | 2 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Magnessium serum, high (n=214, 225, 219) | 12 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Sodium serum, low (n=214, 226, 219) | 8 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Sodium serum, high (n=214, 226, 219) | 1 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Phosphorus inorganic, low (n=213, 224, 219) | 100 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Albumin, low (n=214, 226, 219) | 0 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Uric acid, high (n=214, 226, 219) | 7 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Protein in urine, high (n=213, 224, 217) | 30 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Hemoglobin, low (n=213, 226, 219) | 25 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Leukocytes, low (n=213, 226, 219) | 5 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Alkaline phosphatase, high (n=214, 226, 219) | 4 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Alanine aminotransferase, high (n=214, 226, 219) | 6 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Aspartate aminotransferase, high (n=214, 226, 219) | 3 participants |
| Belatacept LI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Bilirubin total, high (n=214, 226, 219) | 0 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Protein in urine, high (n=213, 224, 217) | 36 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Magnessium serum, low (n=214, 225, 219) | 1 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Calcium total, low (n=214, 226, 219) | 4 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Hemoglobin, low (n=213, 226, 219) | 27 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Potassium serum, high (n=213, 223, 219) | 4 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Potassium serum, low (n=213, 223, 219) | 12 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Platelet count, low (n=213, 226, 218) | 0 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Bicarbonate, high (n=214, 226, 219) | 0 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Bilirubin total, high (n=214, 226, 219) | 0 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Leukocytes, low (n=213, 226, 219) | 5 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Bicarbonate, low (n=214, 226, 219) | 0 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Aspartate aminotransferase, high (n=214, 226, 219) | 3 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Alkaline phosphatase, high (n=214, 226, 219) | 0 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Phosphorus inorganic, low (n=213, 224, 219) | 112 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Sodium serum, high (n=214, 226, 219) | 0 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Calcium total, high (n=214, 226, 219) | 0 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Albumin, low (n=214, 226, 219) | 0 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Sodium serum, low (n=214, 226, 219) | 9 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Creatinine, high (n=213, 223, 219) | 52 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Uric acid, high (n=214, 226, 219) | 11 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Magnessium serum, high (n=214, 225, 219) | 14 participants |
| Belatacept MI | Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 | Alanine aminotransferase, high (n=214, 226, 219) | 4 participants |
Secondary
Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36
Allograft rejection includes any episode of rejection including: clinically suspected rejection, treated rejection, any central biopsy-proven acute rejection (BPAR), and acute rejection (AR: a subset of BPAR) defined as central biopsy-proven rejection that was either clinically suspected by protocol-defined reasons or by other reasons and was treated. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence ( either an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of AR) and renal biopsy confirmation biopsy demonstrating a Banff 97 working classification of kidney transplant pathology classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the highest Banff grade for each participant was counted.
Time frame: Randomization to Month 36
Population: All randomized and transplanted participants, intent to treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 | Month 6 | 43 participants |
| Cyclosporine | Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 | Month 12 | 56 participants |
| Cyclosporine | Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 | Month 24 | 63 participants |
| Cyclosporine | Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 | Month 36 | 69 participants |
| Belatacept LI | Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 | Month 36 | 76 participants |
| Belatacept LI | Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 | Month 6 | 68 participants |
| Belatacept LI | Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 | Month 24 | 74 participants |
| Belatacept LI | Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 | Month 12 | 72 participants |
| Belatacept MI | Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 | Month 36 | 82 participants |
| Belatacept MI | Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 | Month 12 | 75 participants |
| Belatacept MI | Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 | Month 24 | 81 participants |
| Belatacept MI | Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 | Month 6 | 70 participants |
Secondary
Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12
Acute rejection (AR) = a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Complete recovery following AR defined as serum creatinine \[SCr\] levels returned to baseline. Recovery calculated using 2 algorithms: Algorithm 1 = last laboratory measurement prior to onset of AR (baseline and first laboratory measurement after 84 days since onset of AR = resolution); Algorithm 2 = lowest laboratory measurement on or after transplantation and prior to onset day of AR (baseline and lowest laboratory measurement after onset on first AR up to Month 12 = resolution)
Time frame: Randomization to Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with at least one episode of AR up to Month 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12 | Algorithm 1 | 13 participants |
| Cyclosporine | Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12 | Algorithm 2 | 13 participants |
| Belatacept LI | Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12 | Algorithm 1 | 29 participants |
| Belatacept LI | Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12 | Algorithm 2 | 34 participants |
| Belatacept MI | Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12 | Algorithm 1 | 39 participants |
| Belatacept MI | Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12 | Algorithm 2 | 43 participants |
Secondary
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36
Acute rejection was defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.
Time frame: Randomization to Month 36
Population: All randomized and transplanted participants, intent to treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Severe Acute (III); Month 24 | 0 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIA); Month 12 | 6 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IA); Month 6 | 1 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIB); Month 24 | 3 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIB); Month 12 | 2 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIB); Month 6 | 1 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIA); Month 24 | 6 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Severe Acute (III); Month 12 | 0 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Severe Acute (III); Month 36 | 0 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IB); Month 24 | 7 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IA); Month 24 | 4 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIA); Month 36 | 6 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Severe Acute (III); Month 6 | 0 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIB); Month 36 | 3 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IB); Month 36 | 7 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IA); Month 12 | 3 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIA); Month 6 | 5 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IA); Month 36 | 5 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IB); Month 12 | 5 participants |
| Cyclosporine | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IB); Month 6 | 5 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIA); Month 36 | 16 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IA); Month 6 | 4 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IB); Month 6 | 9 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIA); Month 6 | 14 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIB); Month 6 | 10 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Severe Acute (III); Month 6 | 1 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IA); Month 12 | 4 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IB); Month 12 | 8 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIA); Month 12 | 16 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIB); Month 12 | 10 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Severe Acute (III); Month 12 | 1 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IA); Month 24 | 4 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IB); Month 24 | 8 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIA); Month 24 | 16 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIB); Month 24 | 10 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Severe Acute (III); Month 24 | 1 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IA); Month 36 | 4 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IB); Month 36 | 8 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIB); Month 36 | 10 participants |
| Belatacept LI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Severe Acute (III); Month 36 | 1 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IB); Month 6 | 3 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIB); Month 24 | 22 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IB); Month 12 | 3 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Severe Acute (III); Month 36 | 3 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Severe Acute (III); Month 24 | 3 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IA); Month 12 | 7 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIB); Month 36 | 22 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IA); Month 36 | 7 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Severe Acute (III); Month 6 | 2 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IA); Month 6 | 7 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IB); Month 36 | 3 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIB); Month 6 | 20 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IA); Month 24 | 7 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Severe Acute (III); Month 12 | 2 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIA); Month 6 | 16 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Mild Acute (IB); Month 24 | 3 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIB); Month 12 | 20 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIA); Month 36 | 18 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIA); Month 24 | 18 participants |
| Belatacept MI | Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 | Moderate Acute (IIA); Month 12 | 17 participants |
Secondary
Number of Participants With Adverse Events of Special Interest by Month 84
Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections and Infestations, Thrombolic/embolic events, and Malignancy. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/ abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Time frame is from randomization to the event date, or to the last dose date+56, or to Month 84 (Day 2548), whichever is the earliest.
Time frame: Randomization to Month 84
Population: All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Number of Participants With Adverse Events of Special Interest by Month 84 | Pulmonary edema or Congestive Heart Failure | 12 participants |
| Cyclosporine | Number of Participants With Adverse Events of Special Interest by Month 84 | Malignancies | 22 participants |
| Cyclosporine | Number of Participants With Adverse Events of Special Interest by Month 84 | Cytomegalovirus (CMV) Infections | 19 participants |
| Cyclosporine | Number of Participants With Adverse Events of Special Interest by Month 84 | BK Polyoma Virus Infections | 6 participants |
| Cyclosporine | Number of Participants With Adverse Events of Special Interest by Month 84 | Herpes Virus Infections | 29 participants |
| Cyclosporine | Number of Participants With Adverse Events of Special Interest by Month 84 | Fungal Infections | 42 participants |
| Cyclosporine | Number of Participants With Adverse Events of Special Interest by Month 84 | Tuberculosis Infections | 2 participants |
| Cyclosporine | Number of Participants With Adverse Events of Special Interest by Month 84 | Central Nervous System (CNS) Infections | 0 participants |
| Cyclosporine | Number of Participants With Adverse Events of Special Interest by Month 84 | Auto-immune Events | 8 participants |
| Belatacept LI | Number of Participants With Adverse Events of Special Interest by Month 84 | Fungal Infections | 47 participants |
| Belatacept LI | Number of Participants With Adverse Events of Special Interest by Month 84 | Auto-immune Events | 8 participants |
| Belatacept LI | Number of Participants With Adverse Events of Special Interest by Month 84 | Malignancies | 16 participants |
| Belatacept LI | Number of Participants With Adverse Events of Special Interest by Month 84 | Pulmonary edema or Congestive Heart Failure | 4 participants |
| Belatacept LI | Number of Participants With Adverse Events of Special Interest by Month 84 | Central Nervous System (CNS) Infections | 0 participants |
| Belatacept LI | Number of Participants With Adverse Events of Special Interest by Month 84 | Cytomegalovirus (CMV) Infections | 24 participants |
| Belatacept LI | Number of Participants With Adverse Events of Special Interest by Month 84 | Herpes Virus Infections | 37 participants |
| Belatacept LI | Number of Participants With Adverse Events of Special Interest by Month 84 | Tuberculosis Infections | 1 participants |
| Belatacept LI | Number of Participants With Adverse Events of Special Interest by Month 84 | BK Polyoma Virus Infections | 10 participants |
| Belatacept MI | Number of Participants With Adverse Events of Special Interest by Month 84 | Tuberculosis Infections | 5 participants |
| Belatacept MI | Number of Participants With Adverse Events of Special Interest by Month 84 | Herpes Virus Infections | 37 participants |
| Belatacept MI | Number of Participants With Adverse Events of Special Interest by Month 84 | Pulmonary edema or Congestive Heart Failure | 5 participants |
| Belatacept MI | Number of Participants With Adverse Events of Special Interest by Month 84 | Fungal Infections | 55 participants |
| Belatacept MI | Number of Participants With Adverse Events of Special Interest by Month 84 | Auto-immune Events | 6 participants |
| Belatacept MI | Number of Participants With Adverse Events of Special Interest by Month 84 | BK Polyoma Virus Infections | 15 participants |
| Belatacept MI | Number of Participants With Adverse Events of Special Interest by Month 84 | Malignancies | 20 participants |
| Belatacept MI | Number of Participants With Adverse Events of Special Interest by Month 84 | Cytomegalovirus (CMV) Infections | 20 participants |
| Belatacept MI | Number of Participants With Adverse Events of Special Interest by Month 84 | Central Nervous System (CNS) Infections | 1 participants |
Secondary
Number of Participants With Antihyperlipidemic Medication by Intensity Level
An intensity level was associated with the dose level of the statin based anti-hyperlipidemic agent. Any other agent (i.e., non-statin therapy) used as an antihyperlipidemic were considered Level I treatment intensity. Multiple daily dose levels during a period were averaged to compute the daily dose during that period. Level I = 20 mg fluvastatin (flu), 10 mg lovastatin (lova), 10 mg pravastatin (prav), 5-10 mg simvastatin (sim); Level II = 10 mg atorvastatin (atorv), 40 mg flu, 20 mg lova, 20 mg prav, 5 mg rosuvastatin (rosu), 20 mg sim, 10/10 vytorin; Level III = 20 mg atorv, 80 mg flu, 40 mg lova, 40 mg prav, 10 mg rosu, 40 mg sim, 10/20 vytorin; Level IV = 40 mg atorv, 80 mg lova, 80 mg prav, 20 mg rosu, 80 mg sim, 10/40 vytorin; Level V = 80 mg atorv, 40 mg rosu, 10/80 vytorin. Concomitant use of a statin and an agent of another class elevated the intensity level of the statin therapy by 1 level; therefore, an intensity level of greater than V was possible.
Time frame: Month 36
Population: All randomized and transplanted participants that received at least one hyperlipidemic medication; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level I | 17 participants |
| Cyclosporine | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level II | 46 participants |
| Cyclosporine | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level III | 27 participants |
| Cyclosporine | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level IV | 8 participants |
| Cyclosporine | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level V | 4 participants |
| Cyclosporine | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level VI | 1 participants |
| Belatacept LI | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level VI | 1 participants |
| Belatacept LI | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level I | 15 participants |
| Belatacept LI | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level IV | 16 participants |
| Belatacept LI | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level V | 1 participants |
| Belatacept LI | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level II | 27 participants |
| Belatacept LI | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level III | 32 participants |
| Belatacept MI | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level II | 39 participants |
| Belatacept MI | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level III | 23 participants |
| Belatacept MI | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level VI | 0 participants |
| Belatacept MI | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level IV | 9 participants |
| Belatacept MI | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level I | 17 participants |
| Belatacept MI | Number of Participants With Antihyperlipidemic Medication by Intensity Level | Intensity Level V | 4 participants |
Secondary
Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84
Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Time frame: Randomization to Month 84
Population: All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 | Deaths | 9 participants |
| Cyclosporine | Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 | SAEs | 107 participants |
| Cyclosporine | Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 | Discontinued due to SAEs | 5 participants |
| Cyclosporine | Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 | Discontinued due to AEs | 12 participants |
| Belatacept LI | Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 | Discontinued due to AEs | 11 participants |
| Belatacept LI | Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 | Deaths | 7 participants |
| Belatacept LI | Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 | Discontinued due to SAEs | 8 participants |
| Belatacept LI | Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 | SAEs | 113 participants |
| Belatacept MI | Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 | Discontinued due to AEs | 14 participants |
| Belatacept MI | Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 | SAEs | 117 participants |
| Belatacept MI | Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 | Discontinued due to SAEs | 6 participants |
| Belatacept MI | Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 | Deaths | 7 participants |
Secondary
Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12
Incidence of dyslipidemia was defined as the proportion of participants who developed dyslipidemia after randomization and transplantation. Dyslipidemia was defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia = hypertriglyceridemia (TGs \>= 500 milligrams/deciliter (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 \[2.26 mmol/L\]). The TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \>=5. Otherwise exact method is used.
Time frame: Randomization to Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12 | 80.0 percentage of participants |
| Belatacept LI | Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12 | 63.8 percentage of participants |
| Belatacept MI | Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12 | 70.9 percentage of participants |
Secondary
Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12
Controlled hypertension was defined as a SBP \< 130 mm Hg and a DBP \< 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP \< 130 mm Hg and a DBP \< 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP
Time frame: Day 1 to Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with baseline hypertension
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12 | 21.4 percentage of participants |
| Belatacept LI | Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12 | 28.6 percentage of participants |
| Belatacept MI | Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12 | 24.6 percentage of participants |
Comparison: At Month 1297.3% CI: [-2.9, 17.1]
Comparison: At Month 1297.3% CI: [-6.6, 12.9]
Secondary
Percent of Participants Surviving With a Functioning Graft
Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.
Time frame: Months 24, 36
Population: All randomized and transplanted participants, intent to treat (ITT) population. For 95% CI within each group, normal approximation is used in N\>=5. Otherwise exact method is used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Percent of Participants Surviving With a Functioning Graft | Month 24 | 90.5 percentage of participants |
| Cyclosporine | Percent of Participants Surviving With a Functioning Graft | Month 36 | 88.7 percentage of participants |
| Belatacept LI | Percent of Participants Surviving With a Functioning Graft | Month 24 | 94.7 percentage of participants |
| Belatacept LI | Percent of Participants Surviving With a Functioning Graft | Month 36 | 92.0 percentage of participants |
| Belatacept MI | Percent of Participants Surviving With a Functioning Graft | Month 24 | 94.1 percentage of participants |
| Belatacept MI | Percent of Participants Surviving With a Functioning Graft | Month 36 | 92.2 percentage of participants |
Comparison: Month 2497.3% CI: [-1.3, 10.1]
Comparison: Month 2497.3% CI: [-2.2, 9.6]
Comparison: Month 3697.3% CI: [-2.9, 9.8]
97.3% CI: [-2.8, 10]
Secondary
Percent of Participants Using At Least One Anti-Hyperlipidemic Medication
This analysis is based on all participants who were followed up at least 1092 days after transplantation.
Time frame: Month 36
Population: All randomized and transplanted participants, intent-to-treat (ITT) population; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants Using At Least One Anti-Hyperlipidemic Medication | 56.6 percentage of participants |
| Belatacept LI | Percent of Participants Using At Least One Anti-Hyperlipidemic Medication | 46.2 percentage of participants |
| Belatacept MI | Percent of Participants Using At Least One Anti-Hyperlipidemic Medication | 47.9 percentage of participants |
97.3% CI: [-21.4, 1]
97.3% CI: [-19.9, 2.7]
Secondary
Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36
This analysis was based on all participants who had been followed up at least 1092 days after transplantation. Hypertension was defined in according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. In addition, all participants who had a SBP \< 130 mm Hg and a DBP \< 80 mm Hg who received an antihypertensive medication(s) for the indication of hypertension or with a medical history of hypertension were included in this definition. Systolic blood pressure = SBP; Diastolic blood pressure = DBP
Time frame: Month 36
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36 | 92.9 percentage of participants |
| Belatacept LI | Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36 | 81.9 percentage of participants |
| Belatacept MI | Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36 | 83.9 percentage of participants |
p-value: 0.000297.3% CI: [0.31, 0.74]Chi-squared
p-value: 0.009297.3% CI: [0.38, 0.92]Chi-squared
Secondary
Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36
The use of LDT (thymoglobulin or antithymocyte gamma globulin \[ATGAM\]) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated delayed graft function following transplantation. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence (an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed) and biopsy confirmation. AR defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.
Time frame: Randomization to Month 36
Population: All randomized and transplanted participants, intent to treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 | Month 6 | 0.5 percentage of participants |
| Cyclosporine | Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 | Month 12 | 0.9 percentage of participants |
| Cyclosporine | Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 | Month 24 | 1.4 percentage of participants |
| Cyclosporine | Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 | Month 36 | 1.8 percentage of participants |
| Belatacept LI | Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 | Month 36 | 4.4 percentage of participants |
| Belatacept LI | Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 | Month 6 | 4.4 percentage of participants |
| Belatacept LI | Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 | Month 24 | 4.4 percentage of participants |
| Belatacept LI | Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 | Month 12 | 4.4 percentage of participants |
| Belatacept MI | Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 | Month 36 | 5.9 percentage of participants |
| Belatacept MI | Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 | Month 12 | 5.9 percentage of participants |
| Belatacept MI | Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 | Month 24 | 5.9 percentage of participants |
| Belatacept MI | Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 | Month 6 | 5.9 percentage of participants |
Secondary
Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12
A participant was considered to have delayed graft function (DGF), if treated with dialysis within the first week (Day 1 - 8) after transplantation. The use of polyclonal antilymphocyte preparations (LDT) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated DGF following transplantation and were not permitted in belatacept-treated participants, except for the treatment of acute rejection. Participants treated with LDT began CsA at the discretion of the investigator by Day 7. LDT could also have been used in participants who met \>= 1 of the following criteria, observed in the presence of a transplant artery and vein and no evidence of hydronephrosis by sonogram: Urine output \< 250 mL/12 hours, no significant improvement (\< 1 milligram per deciliter (mg/dL)) in serum creatinine from baseline value over the first 24 - 72 hours post-transplant, or dialysis treatment.
Time frame: Randomization to Month 12
Population: All randomized and transplanted participants, intent to treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12 | 3.6 percentage of participants |
| Belatacept LI | Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12 | 0.4 percentage of participants |
| Belatacept MI | Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12 | 0.5 percentage of participants |
95% CI: [-6.6, -0.6]
95% CI: [-6.6, -0.6]
Secondary
Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12
Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A change in GFR of at least 10 mL/min/1.73 m\^2 was used as the approximate change in serum creatinine (SCr) of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3. Month 3 = baseline
Time frame: Month 3 to Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12 | 28.2 percentage of participants |
| Belatacept LI | Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12 | 23.4 percentage of participants |
| Belatacept MI | Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12 | 23.0 percentage of participants |
Secondary
Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12
Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m\^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 milligrams per deciliter (mg/dL).
Time frame: Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 | 67.6 percentage of participants |
| Belatacept LI | Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 | 43 percentage of participants |
| Belatacept MI | Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 | 43.5 percentage of participants |
Secondary
Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36
Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant. Acute rejection was defined as central biopsy proven rejection that was either (1) clinically suspected by protocol defined reasons or (2) clinically suspected by other reasons and treated. Death and graft loss were not imputed.
Time frame: Randomization to Month 36
Population: All randomized and transplanted participants, intent to treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 | Month 24 | 18.1 percentage of participants |
| Cyclosporine | Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 | Month 12 | 13.6 percentage of participants |
| Cyclosporine | Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 | Month 36 | 19.9 percentage of participants |
| Belatacept LI | Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 | Month 24 | 19.9 percentage of participants |
| Belatacept LI | Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 | Month 12 | 19.5 percentage of participants |
| Belatacept LI | Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 | Month 36 | 20.8 percentage of participants |
| Belatacept MI | Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 | Month 12 | 25.1 percentage of participants |
| Belatacept MI | Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 | Month 36 | 28.3 percentage of participants |
| Belatacept MI | Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 | Month 24 | 27.9 percentage of participants |
Comparison: Month 1295% CI: [-1, 12.8]
Comparison: Month 1295% CI: [4.2, 18.9]
Comparison: Month 2495% CI: [-5.5, 9.1]
Comparison: Month 2495% CI: [1.9, 17.6]
Comparison: Month 3695% CI: [-6.6, 8.4]
Comparison: Month 3695% CI: [0.4, 16.4]
Secondary
Percent of Participants With Controlled Dyslipidemia at Month 12
Prevalence of controlled dyslipidemia = the proportion of participants at any given time who met the stated definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs \>= 500 milligrams/deciliter (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 \[2.26 mmol/L\]). Controlled dyslipidemia defined as participants who received successful pharmacologic treatment for 1 of the above stated dyslipidemias, and their lipid values fell below the thresholds described. TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \>=5. Otherwise exact method is used.
Time frame: Month 12
Population: All randomized and transplanted participants, intent-to-treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants With Controlled Dyslipidemia at Month 12 | 18.1 percentage of participants |
| Belatacept LI | Percent of Participants With Controlled Dyslipidemia at Month 12 | 15.5 percentage of participants |
| Belatacept MI | Percent of Participants With Controlled Dyslipidemia at Month 12 | 15.5 percentage of participants |
Secondary
Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36
Steroid-resistant acute rejection (AR) defined as the use of lymphocyte-depletion therapy following treatment with corticosteroids. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 international standardized histopathological working classification of kidney transplant pathology. Only the episode with the highest Banff grade for each participant was counted.
Time frame: Randomization to Month 36
Population: All randomized and transplanted participants, intent to treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 | Month 6 | 0.0 percentage of participants |
| Cyclosporine | Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 | Month 12 | 0.0 percentage of participants |
| Cyclosporine | Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 | Month 24 | 0.5 percentage of participants |
| Cyclosporine | Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 | Month 36 | 0.5 percentage of participants |
| Belatacept LI | Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 | Month 36 | 5.3 percentage of participants |
| Belatacept LI | Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 | Month 6 | 4.0 percentage of participants |
| Belatacept LI | Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 | Month 24 | 5.3 percentage of participants |
| Belatacept LI | Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 | Month 12 | 5.3 percentage of participants |
| Belatacept MI | Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 | Month 36 | 6.8 percentage of participants |
| Belatacept MI | Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 | Month 12 | 6.4 percentage of participants |
| Belatacept MI | Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 | Month 24 | 6.4 percentage of participants |
| Belatacept MI | Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 | Month 6 | 5.9 percentage of participants |
Secondary
Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84
Only participants who had non-missing test result for Class I or Class II anti-donor HLA antibodies were included in analysis and only participants who had at least one non-NA test result or finding were counted. This was a cumulative summary (excluding baseline) and once a participant was positive, that participant remained positive for the later time point. Acute rejection (AR) defined: a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence defined: if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. AR defined as allograft biopsies of Banff 97 classification Grade IA or greater (higher scores indicate more severe rejection). Evaluated by blinded central independent pathologist.
Time frame: Randomization to Month 84
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84 | 11.6 percentage of participants |
| Belatacept LI | Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84 | 3.1 percentage of participants |
| Belatacept MI | Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84 | 1.4 percentage of participants |
Comparison: Percent treatment difference measured as Belatacept - LI minus Cyclosporine97.3% CI: [-14.6, -3.3]
Comparison: Percent treatment difference measured as Belatacept - LI minus Cyclosporine97.3% CI: [-16.1, -5.1]
Secondary
Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12
The incidence of hypertension was defined as the proportion of participants who developed hypertension after randomization and transplantation. Specifically, the incidence of hypertension was assessed only after the Week 4 visit. This period allowed for adequate stabilization and resolution of transient changes. If participants received antihypertensive medication for the indication of hypertension at this (or later) time point, they were considered to have developed hypertension. Hypertension was defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for subjects with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP
Time frame: Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12 | 75.0 percentage of participants |
| Belatacept LI | Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12 | 53.8 percentage of participants |
| Belatacept MI | Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12 | 57.1 percentage of participants |
Comparison: Month 1297.3% CI: [-67.6, 43.2]
Comparison: Month 1297.3% CI: [-72.3, 52.2]
Secondary
Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36
The incidence of new onset diabetes mellitus defined as participants who developed diabetes mellitus after randomization and transplantation. Participants that did not have diabetes prior to randomization were determined to have new onset diabetes mellitus if (i) the participant received an anti-diabetic 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). New onset diabetes mellitus (NODM) = post-transplant diabetes mellitus (PTDM)
Time frame: Week 4 post-transplantation to Month 36
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 | Month 24 | 10.5 percentage of participants |
| Cyclosporine | Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 | Month 12 | 9.9 percentage of participants |
| Cyclosporine | Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 | Month 36 | 11.1 percentage of participants |
| Belatacept LI | Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 | Month 24 | 5.4 percentage of participants |
| Belatacept LI | Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 | Month 12 | 4.2 percentage of participants |
| Belatacept LI | Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 | Month 36 | 6.5 percentage of participants |
| Belatacept MI | Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 | Month 12 | 7.1 percentage of participants |
| Belatacept MI | Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 | Month 36 | 10.3 percentage of participants |
| Belatacept MI | Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 | Month 24 | 8.3 percentage of participants |
Comparison: Month 12p-value: 0.068797.3% CI: [-12.6, 0.5]Chi-squared
Comparison: Month 12p-value: 0.482597.3% CI: [-10.2, 4.4]Chi-squared
Comparison: Month 24p-value: 0.126797.3% CI: [-12.3, 1.5]Chi-squared
Comparison: Month 24p-value: 0.640597.3% CI: [-9.8, 5.4]Chi-squared
Comparison: Month 36p-value: 0.204397.3% CI: [-12, 2.5]Chi-squared
Comparison: Month 36p-value: 0.948197.3% CI: [-8.8, 7.1]Chi-squared
Secondary
Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36
Prevalence of AR = participants with the stated definition of AR at any given time. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification.
Time frame: Randomization to Month 36
Population: All randomized and transplanted participants, intent to treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 | Month 24 (n=221, 226, 219) | 9.0 percentage of participants |
| Cyclosporine | Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 | Month 6 (n=221, 226, 219) | 5.4 percentage of participants |
| Cyclosporine | Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 | Month 36 (n=221, 226, 219) | 9.5 percentage of participants |
| Belatacept LI | Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 | Month 24 (n=221, 226, 219) | 17.3 percentage of participants |
| Belatacept LI | Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 | Month 6 (n=221, 226, 219) | 16.8 percentage of participants |
| Belatacept LI | Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 | Month 36 (n=221, 226, 219) | 17.3 percentage of participants |
| Belatacept MI | Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 | Month 6 (n=221, 226, 219) | 21.9 percentage of participants |
| Belatacept MI | Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 | Month 36 (n=221, 226, 219) | 24.2 percentage of participants |
| Belatacept MI | Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 | Month 24 (n=221, 226, 219) | 24.2 percentage of participants |
Comparison: Month 697.3% CI: [5, 18.2]
Comparison: Month 697.3% CI: [9.6, 23.8]
Comparison: Month 2497.3% CI: [1.2, 15.4]
Comparison: Month 2497.3% CI: [7.5, 23]
Comparison: Month 3697.3% CI: [0.6, 15]
Comparison: Month 3697.3% CI: [7, 22.6]
Secondary
Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12
Prevalence of CAN = if participant met any of the following conditions: a: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; b: participant had graft loss during the first year post transplant; c: no biopsy was available post 12 months and CAN not observed in biopsies prior to 12 months, but the measured GFR from Month 3 to Month 12 decreased at least 10 mL/min/1.73m\^2; d: no biopsy available either prior to or post 12 months, and the measured GFR (incorporated missing data imputation) from Month 3 to Month 12 decreased at least 10 mL/min/1.73m\^2. CAN = All allograft biopsies evaluated for presence and severity of CAN by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Onset of CAN determined by the biopsy date when it was observed.
Time frame: Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component; Any participant not meeting CAN criteria and who has no biopsy either prior to or post 12 months and no GFR assessment (either measured or calculated) available were excluded from the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12 | 32.4 percentage of participants |
| Belatacept LI | Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12 | 23.9 percentage of participants |
| Belatacept MI | Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12 | 18.3 percentage of participants |
p-value: 0.058197.3% CI: [-17.9, 0.9]Chi-squared, Corrected
p-value: 0.00197.3% CI: [-23.2, -5]Chi-squared, Corrected
Secondary
Percent of Participants With Prevalence of Controlled Hypertension at Month 12
The prevalence of controlled hypertension was defined as the proportion of participants at any given time who met the definition of controlled hypertension. Controlled hypertension was defined as a SBP \< 130 mm Hg and a DBP \< 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP \< 130 mm Hg and a DBP \< 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP
Time frame: Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants With Prevalence of Controlled Hypertension at Month 12 | 21.0 percentage of participants |
| Belatacept LI | Percent of Participants With Prevalence of Controlled Hypertension at Month 12 | 28.0 percentage of participants |
| Belatacept MI | Percent of Participants With Prevalence of Controlled Hypertension at Month 12 | 24.7 percentage of participants |
97.3% CI: [-2.79, 16.71]
97.3% CI: [-5.86, 13.35]
Secondary
Percent of Participants With Prevalence of Dyslipidemia at Month 12
The prevalence of dyslipidemia was defined as the proportion of participants at any given time who met the definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs \>= 500 milligrams/deciliter (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 \[2.26 mmol/L\]). TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \>=5. Otherwise exact method is used.
Time frame: Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants With Prevalence of Dyslipidemia at Month 12 | 52.9 percentage of participants |
| Belatacept LI | Percent of Participants With Prevalence of Dyslipidemia at Month 12 | 44.7 percentage of participants |
| Belatacept MI | Percent of Participants With Prevalence of Dyslipidemia at Month 12 | 46.1 percentage of participants |
Secondary
Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12
The prevalence of hypertension was defined as the proportion of participants at any given time who meet the definition of hypertension. Hypertension defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition is based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP
Time frame: Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12 | 91.0 percentage of participants |
| Belatacept LI | Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12 | 89.8 percentage of participants |
| Belatacept MI | Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12 | 88.6 percentage of participants |
Comparison: Month 1297.3% CI: [-7.51, 5.23]
Comparison: Month 1297.3% CI: [-9.01, 4.15]
Secondary
Percent of Participants With Subclinical Rejection at Month 12
Subclinical rejection defined as histological findings by the central pathologist consistent with acute rejection, but lacking its clinical correlate. Acute rejection defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence defined if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology.
Time frame: Month 12
Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Percent of Participants With Subclinical Rejection at Month 12 | 5.2 percentage of participants |
| Belatacept LI | Percent of Participants With Subclinical Rejection at Month 12 | 4.7 percentage of participants |
| Belatacept MI | Percent of Participants With Subclinical Rejection at Month 12 | 4.3 percentage of participants |
Comparison: Month 1297.3% CI: [-6.5, 5.3]
97.3% CI: [-6.9, 4.8]