Graft Rejection, Kidney Transplantation, Renal Transplantation
Conditions
Keywords
kidney, transplant, rejection
Brief summary
The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is as efficacious as treatment with cyclosporine at preventing acute rejection and with a superior safety/tolerability profile (better kidney function and blood pressure, fewer lipid problems, less diabetes mellitus).
Interventions
DRUGBelatacept
Solution, intravenous
DRUGCyclosporine
Oral, capsule
DRUGMycophenolate mofetil (MMF)
Oral, capsule
DRUGCorticosteroids
Corticosteroids given daily, orally or intravenously (IV). Day of transplant (Day 1): methylprednisolone, 500 mg, given IV on arrival in operating room; Day 2: methylprednisolone, 250 mg, given IV once daily; Day 3: prednisone, 100 mg, given orally once daily; Day 4: prednisone, 50 mg, given orally once daily; Days 5 through 30: prednisone, 25 mg, given orally once daily; Days 31-44: prednisone, 22.5 mg, given orally once daily; Days 45-58: prednisone, 20 mg, given orally once daily
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria * Recipients of first kidney transplant Key
Exclusion criteria
* Those at high risk for acute allograft rejection, including those who receive a second or more renal transplant, those with a history of panel reactive antibody levels \>20%, and those considered by investigators to be at relatively higher risk for acute rejection * Human leukocyte antigen-identical donor-recipient pairs * Cold ischemia time \>36 hours (donor kidney) * Participants who are positive for hepatitis C antibody, on polymerase chain reaction, for hepatitis B surface antigen, and for human immunodeficiency virus * A positive purified protein derivative tuberculosis test (test performed within 1 year of enrollment), unless previously vaccinated with Bacille-Calmette-Guérin or those who had a history of adequate chemoprophylaxis * Any active infection that would normally exclude transplantation * Recipients of multiple organ transplants * Donor age \>60 or \<6 years or donors whose hearts were not beating * Recipients with underlying renal disease of (due to risk of rapid disease recurrence in the allograft): focal segmental glomerulosclerosis, Type I or II membranoproliferative glomerulonephritis, or hemolytic uremic syndrome/ thrombotic thrombocytopenic purpura * A positive T-cell lymphocytoxic crossmatch using donor lymphocytes and recipient serum * A history of true allergy to intravenous iodinated roentgenographic contrast agents * Participants with life expectancy severely limited by disease state or other underlying medical condition * A history of cancer (other than nonmelanoma skin cell cancers cured by local resection) within the last 5 years * Mammogram film with any clinically significant abnormality requiring further investigation or biopsies * History of substance abuse (drug or alcohol) or psychotic disorders that were not compatible with adequate study follow-up * A currently functioning, nonrenal transplant * Previous treatment with basiliximab for any reason * Active peptic ulcer disease, chronic diarrhea, or gastrointestinal malabsorption * Those who had used any investigational drug within 30 days before the Day 1 visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR) | By Month 6 posttransplant (From Day 1 to Month 6) | No participant was to receive treatment for acute rejection without a biopsy to confirm the diagnosis. CSPAR=Clinically-suspected rejection, defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function, and biopsy-proven rejection, which includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12 | Through Months 6 and 12 posttransplant (From Day 1 to Months 6 and 12) | BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed. |
| Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection | By Months 3, 6, and 12 posttransplant (Day 1 to Months 3, 6, and 12) | BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed. A participant was reported as having had an episode of treated acute rejection if he or she received antirejection therapy during an episode of rejection (clinically-suspected or biopsy-proven rejection). |
| Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR) | By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12) | Throughout this study, acute rejection=clinically-suspected and biopsy-proven acute rejection (BPAR). Clinically-suspected rejection is defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function. BPAR includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed. PAR is defined as an elevation in SCr ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function that led the investigator to suspect that the participant had experienced acute rejection, and in whom either the biopsy did not confirm acute rejection and the participant received treatment for acute rejection or the participant received treatment for acute rejection without a biopsy to confirm the diagnosis. |
| Percentage of Participants Who Had Chronic Allograft Nephropathy | By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12) | Based on postbaseline biopsies |
| Mean Iohexol Clearance | By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12) | Iohexol, a true glomerular filtration marker, is used to measure glomerular filtration rate. |
| Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12) | LDL=low-density lipoprotein; HDL=high-density lipoprotein. Total cholesterol=LDL + HDL + very low-density (VLDL) cholesterol. VLDL=triglycerides divided by 5. Non-HDL cholesterol=Total cholesterol minus HDL cholesterol. |
| Number of Participants With Posttransplant Diabetes Mellitus | By Months 1, 3, 6, 9, and 12 posttransplant (Day 1 to Months 1, 3, 6, 9, and 12 ) | Posttransplant diabetes mellitus is defined as the need for treatment of hyperglycemia with either an oral agent or insulin for a total of \>4 weeks or hemoglobin A1c (HbA1c) \>7% in a participant not known to be diabetic prior to transplantation |
| Percentage of Participants Who Used Antihypertensive Medication | By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12) | Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg |
| Number of Participants With Hypertension | By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12) | Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg or, the use of any antihypertensive medication. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Day 1 (posttransplant) continuously to 56 days following last dose of study medication | 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. Treatment-related=having certain, probable, possible, or missing relationship to study drug. |
| Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Days 8 and Months 1, 3, 6, 9, and 12 posttransplant (from Day 1) | Normal laboratory values: Hemoglobin (g/dL): Males (18-64 years) 13.8-17, (65 years and older) 11.8-16.8; Females (18-64 years) 12.0-15.6, F (65 years and older) 11.1-15.5. Platelets (per mm\^3) 130,000-400,000. Leukocytes (18 years and older) 3.8-10.8 1000/uL. ALT (u/L)(13 years and older) 0-48. |
Countries
United States
Participant flow
Pre-assignment details
A total of 230 participants who had undergone transplantation were enrolled
Participants by arm
| Arm | Count |
|---|---|
| Belatacept: More Intensive (MI) Regimen The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids. | 74 |
| Belatacept: Less Intensive (LI) Regimen The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids. | 71 |
| Cyclosporine Regimen Cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids. | 73 |
| Total | 218 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 8 | 9 |
| Overall Study | Allograft loss | 1 | 1 | 2 |
| Overall Study | Death | 0 | 0 | 2 |
| Overall Study | Investigator deemed not a good candidate | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Noncompliance | 0 | 1 | 1 |
| Overall Study | Prohibited medication | 1 | 1 | 0 |
| Overall Study | Received cyclosporin in error | 0 | 0 | 1 |
| Overall Study | Treatment failure/lack of efficacy | 7 | 5 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 2 |
Baseline characteristics
| Characteristic | Belatacept: More Intensive (MI) Regimen | Belatacept: Less Intensive (LI) Regimen | Cyclosporine Regimen | Total |
|---|---|---|---|---|
| Age, Continuous | 45.5 Years | 43.0 Years | 46.0 Years | 45.0 Years |
| Age, Customized Between 18 and 45 years | 37 Participants | 42 Participants | 36 Participants | 115 Participants |
| Age, Customized Between 46 and 60 years | 31 Participants | 26 Participants | 33 Participants | 90 Participants |
| Age, Customized Older than 60 years | 6 Participants | 3 Participants | 4 Participants | 13 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 3 Participants | 4 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 6 Participants | 6 Participants | 18 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 4 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 64 Participants | 57 Participants | 59 Participants | 180 Participants |
| Sex: Female, Male Female | 20 Participants | 23 Participants | 24 Participants | 67 Participants |
| Sex: Female, Male Male | 54 Participants | 48 Participants | 49 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 | 66 / 71 | 68 / 74 | 67 / 71 |
| serious Total, serious adverse events | 52 / 71 | 50 / 74 | 42 / 71 |
Outcome results
Primary
Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR)
No participant was to receive treatment for acute rejection without a biopsy to confirm the diagnosis. CSPAR=Clinically-suspected rejection, defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function, and biopsy-proven rejection, which includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed.
Time frame: By Month 6 posttransplant (From Day 1 to Month 6)
Population: All randomized participants who underwent transplantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belatacept: More Intensive (MI) Regimen | Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR) | 5 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR) | 4 Participants |
| Cyclosporine Regimen | Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR) | 6 Participants |
Secondary
Mean Iohexol Clearance
Iohexol, a true glomerular filtration marker, is used to measure glomerular filtration rate.
Time frame: By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)
Population: All randomized participants who underwent transplantation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belatacept: More Intensive (MI) Regimen | Mean Iohexol Clearance | Month 6 (n=41, 41, 31) | 62.2 mL/min per 1.73 m^2 | Standard Deviation 25.6 |
| Belatacept: More Intensive (MI) Regimen | Mean Iohexol Clearance | Month 1 (n=53, 51, 48) | 59.7 mL/min per 1.73 m^2 | Standard Deviation 17.3 |
| Belatacept: More Intensive (MI) Regimen | Mean Iohexol Clearance | Month 12 (n=32, 37, 27) | 66.3 mL/min per 1.73 m^2 | Standard Deviation 20.7 |
| Belatacept: Less Intensive (LI) Regimen | Mean Iohexol Clearance | Month 6 (n=41, 41, 31) | 64.5 mL/min per 1.73 m^2 | Standard Deviation 19.5 |
| Belatacept: Less Intensive (LI) Regimen | Mean Iohexol Clearance | Month 1 (n=53, 51, 48) | 60.2 mL/min per 1.73 m^2 | Standard Deviation 14.4 |
| Belatacept: Less Intensive (LI) Regimen | Mean Iohexol Clearance | Month 12 (n=32, 37, 27) | 62.1 mL/min per 1.73 m^2 | Standard Deviation 15.9 |
| Cyclosporine Regimen | Mean Iohexol Clearance | Month 1 (n=53, 51, 48) | 54.0 mL/min per 1.73 m^2 | Standard Deviation 19.3 |
| Cyclosporine Regimen | Mean Iohexol Clearance | Month 12 (n=32, 37, 27) | 53.5 mL/min per 1.73 m^2 | Standard Deviation 16.4 |
| Cyclosporine Regimen | Mean Iohexol Clearance | Month 6 (n=41, 41, 31) | 56.0 mL/min per 1.73 m^2 | Standard Deviation 19.5 |
Secondary
Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels
LDL=low-density lipoprotein; HDL=high-density lipoprotein. Total cholesterol=LDL + HDL + very low-density (VLDL) cholesterol. VLDL=triglycerides divided by 5. Non-HDL cholesterol=Total cholesterol minus HDL cholesterol.
Time frame: By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)
Population: All randomized participants who received a transplant; n=evaluable participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | HDL cholesterol: Month 12 (n=60, 57, 48) | 53 mg/dL | Standard Deviation 15.7 |
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | LDL cholesterol: Month 12 (n=61, 60, 52) | 120 mg/dL | Standard Deviation 33.8 |
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Triglycerides: Month 6 (n=63, 65, 54) | 177 mg/dL | Standard Deviation 113.1 |
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Total cholesterol: Month 1 (n=69, 69, 65) | 222 mg/dL | Standard Deviation 64.7 |
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | LDL cholesterol: Month 6 (n=63, 66, 55) | 125 mg/dL | Standard Deviation 33.9 |
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Triglycerides: Month 1 (n=69, 69, 65) | 168 mg/dL | Standard Deviation 125.3 |
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Total cholesterol: Month 6 (n=63, 65, 54) | 204 mg/dL | Standard Deviation 40.4 |
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Non-HDL: Month 1 (n=68, 68, 64) | 159 mg/dL | Standard Deviation 62.7 |
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Total cholesterol: Month 12 (n=60, 58, 50) | 198 mg/dL | Standard Deviation 41.4 |
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | HDL cholesterol: Month 1 (n=68, 68, 64) | 64 mg/dL | Standard Deviation 19.4 |
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Non-HDL cholesterol: Month 12 (n=59, 56, 48) | 145 mg/dL | Standard Deviation 36.7 |
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | LDL cholesterol: Month 1 (n=69, 69, 66) | 129 mg/dL | Standard Deviation 48.9 |
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | HDL cholesterol: Month 6 (n=62, 65, 62) | 54 mg/dL | Standard Deviation 14.8 |
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Non-HDL cholesterol: Month 6 (n=62, 64, 51) | 150 mg/dL | Standard Deviation 39.4 |
| Belatacept: More Intensive (MI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Triglycerides: Month 12 (n=60, 58, 50) | 176 mg/dL | Standard Deviation 87.9 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Triglycerides: Month 12 (n=60, 58, 50) | 152 mg/dL | Standard Deviation 63.5 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | LDL cholesterol: Month 1 (n=69, 69, 66) | 120 mg/dL | Standard Deviation 33.2 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | LDL cholesterol: Month 6 (n=63, 66, 55) | 121 mg/dL | Standard Deviation 39.2 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | LDL cholesterol: Month 12 (n=61, 60, 52) | 125 mg/dL | Standard Deviation 32 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | HDL cholesterol: Month 1 (n=68, 68, 64) | 68 mg/dL | Standard Deviation 21.7 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | HDL cholesterol: Month 6 (n=62, 65, 62) | 56 mg/dL | Standard Deviation 19 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | HDL cholesterol: Month 12 (n=60, 57, 48) | 56 mg/dL | Standard Deviation 13.5 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Total cholesterol: Month 1 (n=69, 69, 65) | 210 mg/dL | Standard Deviation 45.6 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Total cholesterol: Month 6 (n=63, 65, 54) | 202 mg/dL | Standard Deviation 47.7 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Total cholesterol: Month 12 (n=60, 58, 50) | 201 mg/dL | Standard Deviation 40 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Triglycerides: Month 1 (n=69, 69, 65) | 147 mg/dL | Standard Deviation 65.3 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Triglycerides: Month 6 (n=63, 65, 54) | 168 mg/dL | Standard Deviation 87.4 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Non-HDL: Month 1 (n=68, 68, 64) | 142 mg/dL | Standard Deviation 40.2 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Non-HDL cholesterol: Month 6 (n=62, 64, 51) | 143 mg/dL | Standard Deviation 42.1 |
| Belatacept: Less Intensive (LI) Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Non-HDL cholesterol: Month 12 (n=59, 56, 48) | 144 mg/dL | Standard Deviation 35.8 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | HDL cholesterol: Month 12 (n=60, 57, 48) | 59 mg/dL | Standard Deviation 18.5 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Non-HDL cholesterol: Month 6 (n=62, 64, 51) | 165 mg/dL | Standard Deviation 55.1 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Triglycerides: Month 6 (n=63, 65, 54) | 198 mg/dL | Standard Deviation 119.7 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | HDL cholesterol: Month 6 (n=62, 65, 62) | 62 mg/dL | Standard Deviation 20.1 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | HDL cholesterol: Month 1 (n=68, 68, 64) | 70 mg/dL | Standard Deviation 21.6 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Triglycerides: Month 12 (n=60, 58, 50) | 186 mg/dL | Standard Deviation 91.6 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | LDL cholesterol: Month 12 (n=61, 60, 52) | 125 mg/dL | Standard Deviation 36.4 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | LDL cholesterol: Month 1 (n=69, 69, 66) | 137 mg/dL | Standard Deviation 42.9 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Non-HDL: Month 1 (n=68, 68, 64) | 169 mg/dL | Standard Deviation 51.5 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Total cholesterol: Month 6 (n=63, 65, 54) | 224 mg/dL | Standard Deviation 54.8 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | LDL cholesterol: Month 6 (n=63, 66, 55) | 131 mg/dL | Standard Deviation 41.4 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Total cholesterol: Month 12 (n=60, 58, 50) | 212 mg/dL | Standard Deviation 44.2 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Total cholesterol: Month 1 (n=69, 69, 65) | 239 mg/dL | Standard Deviation 53.7 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Non-HDL cholesterol: Month 12 (n=59, 56, 48) | 151 mg/dL | Standard Deviation 43.4 |
| Cyclosporine Regimen | Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels | Triglycerides: Month 1 (n=69, 69, 65) | 185 mg/dL | Standard Deviation 103.9 |
Secondary
Number of Participants With Hypertension
Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg or, the use of any antihypertensive medication.
Time frame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Population: All randomized participants who underwent transplantation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Hypertension | At Month 6 | 16 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Hypertension | At Month 12 | 14 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Hypertension | At Month 6 | 15 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Hypertension | At Month 12 | 12 Participants |
| Cyclosporine Regimen | Number of Participants With Hypertension | At Month 6 | 18 Participants |
| Cyclosporine Regimen | Number of Participants With Hypertension | At Month 12 | 11 Participants |
Secondary
Number of Participants With Posttransplant Diabetes Mellitus
Posttransplant diabetes mellitus is defined as the need for treatment of hyperglycemia with either an oral agent or insulin for a total of \>4 weeks or hemoglobin A1c (HbA1c) \>7% in a participant not known to be diabetic prior to transplantation
Time frame: By Months 1, 3, 6, 9, and 12 posttransplant (Day 1 to Months 1, 3, 6, 9, and 12 )
Population: All randomized participants who received transplants and who were not known to be diabetic prior to transplant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 9: Hyperglycemia medication | 2 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 3: HbA1c >7% | 5 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 9: All events | 8 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 6: HbA1c >7% | 6 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 6: All events | 6 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Month 1: HbA1c >7% | 5 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 6: Hyperglycemia medication | 0 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 1: All events | 5 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 12: HbA1c >7% | 7 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 12: All events | 8 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 3: All events | 5 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 12: Hyperglycemia medication | 2 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 9: HbA1c >7% | 7 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 3: Hypoglycemic medication | 0 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Month 1: Hyperglycemia medication | 0 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 3: HbA1c >7% | 1 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 1: All events | 0 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Month 1: Hyperglycemia medication | 0 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Month 1: HbA1c >7% | 0 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 3: All events | 1 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 3: Hypoglycemic medication | 0 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 6: All events | 3 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 6: Hyperglycemia medication | 0 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 6: HbA1c >7% | 3 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 9: All events | 3 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 9: Hyperglycemia medication | 0 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 9: HbA1c >7% | 3 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 12: All events | 4 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 12: Hyperglycemia medication | 0 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 12: HbA1c >7% | 4 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 9: All events | 5 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 3: Hypoglycemic medication | 2 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 1: All events | 1 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 9: Hyperglycemia medication | 2 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 3: All events | 3 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 12: HbA1c >7% | 4 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 9: HbA1c >7% | 3 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 6: All events | 4 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Month 1: HbA1c >7% | 0 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 6: Hyperglycemia medication | 2 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 3: HbA1c >7% | 1 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Month 1: Hyperglycemia medication | 1 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 6: HbA1c >7% | 2 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 12: Hyperglycemia medication | 3 Participants |
| Cyclosporine Regimen | Number of Participants With Posttransplant Diabetes Mellitus | Up to Month 12: All events | 7 Participants |
Secondary
Percentage of Participants Who Had Chronic Allograft Nephropathy
Based on postbaseline biopsies
Time frame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Population: All randomized participants who underwent transplantation and who had at least 1 biopsy following Day 1; n=evaluable participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Had Chronic Allograft Nephropathy | Month 6 (n= 32, 33, 27) | 18.8 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Had Chronic Allograft Nephropathy | Month 12 (n=52, 54, 45) | 28.8 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Had Chronic Allograft Nephropathy | Month 6 (n= 32, 33, 27) | 9.1 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Had Chronic Allograft Nephropathy | Month 12 (n=52, 54, 45) | 20.4 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Had Chronic Allograft Nephropathy | Month 6 (n= 32, 33, 27) | 33.3 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Had Chronic Allograft Nephropathy | Month 12 (n=52, 54, 45) | 44.4 Percentage of participants |
Secondary
Percentage of Participants Who Used Antihypertensive Medication
Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg
Time frame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Population: All randomized participants who underwent transplantation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 4 medications | 11.0 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 1 medication | 24.7 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 2 medications | 23.3 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 3 medications | 23.3 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Total requiring at least 1 medication | 87.7 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 5 medications | 2.7 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 6 medications | 2.7 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring >6 medications | 0.0 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Total requiring at least 1 medication | 79.7 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 1 medication | 21.7 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 2 medications | 23.2 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 3 medications | 23.2 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 4 medications | 8.7 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 5 medications | 5.8 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 6 medications | 1.4 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring >6 medications | 0.0 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 5 medications | 1.4 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 6 medications | 0.0 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring >6 medications | 0.0 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 5 medications | 0.0 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Total requiring at least 1 medication | 71.6 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 1 medication | 26.9 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring >6 medications | 0.0 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 2 medications | 9.0 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Total requiring at least 1 medication | 78.6 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 6 medications | 0.0 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 1 medication | 27.1 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 3 medications | 9.0 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 2 medications | 28.6 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 3 medications | 14.3 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 4 medications | 7.1 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 4 medications | 7.5 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 2 medications | 22.0 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 5 medications | 1.4 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 4 medications | 15.3 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 2 medications | 31.9 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 6 medications | 0.0 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring >6 medications | 0.0 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Total requiring at least 1 medication | 88.4 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring >6 medications | 0.0 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 3 medications | 22.0 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 4 medications | 11.6 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Total requiring at least 1 medication | 86.4 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 5 medications | 3.4 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 1 medication | 21.7 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 1 medication | 20.3 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 6: Requiring 3 medications | 21.7 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants Who Used Antihypertensive Medication | Month 12: Requiring 6 medications | 0.0 Percentage of participants |
Secondary
Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR)
Throughout this study, acute rejection=clinically-suspected and biopsy-proven acute rejection (BPAR). Clinically-suspected rejection is defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function. BPAR includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed. PAR is defined as an elevation in SCr ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function that led the investigator to suspect that the participant had experienced acute rejection, and in whom either the biopsy did not confirm acute rejection and the participant received treatment for acute rejection or the participant received treatment for acute rejection without a biopsy to confirm the diagnosis.
Time frame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Population: All randomized participants who underwent transplantation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR) | Month 6: Acute rejection or PAR | 11 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR) | Month 12: Acute rejection or PAR | 11 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR) | Month 6: PAR | 5 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR) | Month 12: PAR | 5 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR) | Month 12: PAR | 4 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR) | Month 6: Acute rejection or PAR | 9 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR) | Month 6: PAR | 3 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR) | Month 12: Acute rejection or PAR | 10 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR) | Month 12: PAR | 3 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR) | Month 12: Acute rejection or PAR | 11 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR) | Month 6: PAR | 1 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR) | Month 6: Acute rejection or PAR | 10 Percentage of participants |
Secondary
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection
BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed. A participant was reported as having had an episode of treated acute rejection if he or she received antirejection therapy during an episode of rejection (clinically-suspected or biopsy-proven rejection).
Time frame: By Months 3, 6, and 12 posttransplant (Day 1 to Months 3, 6, and 12)
Population: All randomized participants who underwent transplantation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection | By Month 6 | 23.0 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection | By Month 3 | 21.6 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection | By Month 12 | 28.4 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection | By Month 6 | 32.4 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection | By Month 3 | 29.6 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection | By Month 12 | 38.0 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection | By Month 3 | 17.8 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection | By Month 12 | 27.4 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection | By Month 6 | 24.7 Percentage of participants |
Secondary
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12
BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed.
Time frame: Through Months 6 and 12 posttransplant (From Day 1 to Months 6 and 12)
Population: All randomized participants who underwent transplantation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12 | Up to 6 months | 14.9 Percentage of participants |
| Belatacept: More Intensive (MI) Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12 | Up to 12 months | 18.9 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12 | Up to 6 months | 23.9 Percentage of participants |
| Belatacept: Less Intensive (LI) Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12 | Up to 12 months | 29.6 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12 | Up to 6 months | 17.8 Percentage of participants |
| Cyclosporine Regimen | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12 | Up to 12 months | 17.8 Percentage of participants |
Other Pre-specified
Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results
Normal laboratory values: Hemoglobin (g/dL): Males (18-64 years) 13.8-17, (65 years and older) 11.8-16.8; Females (18-64 years) 12.0-15.6, F (65 years and older) 11.1-15.5. Platelets (per mm\^3) 130,000-400,000. Leukocytes (18 years and older) 3.8-10.8 1000/uL. ALT (u/L)(13 years and older) 0-48.
Time frame: Days 8 and Months 1, 3, 6, 9, and 12 posttransplant (from Day 1)
Population: All randomized participants who underwent transplantation and who received treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept: More Intensive (MI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Hemoglobin, low | 13 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Hemoglobin, high | NA Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Platelet count, low | 1 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Platelet count, high | NA Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Leukocytes, low | 1 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Leukocytes, high | NA Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Alanine aminotransferase (ALT), low | NA Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | ALT, high | 9 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Platelet count, low | 0 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Alanine aminotransferase (ALT), low | NA Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Platelet count, high | NA Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Leukocytes, low | 4 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Leukocytes, high | NA Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Hemoglobin, low | 7 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Hemoglobin, high | NA Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | ALT, high | 3 Participants |
| Cyclosporine Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Platelet count, low | 3 Participants |
| Cyclosporine Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Hemoglobin, high | NA Participants |
| Cyclosporine Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Hemoglobin, low | 9 Participants |
| Cyclosporine Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Platelet count, high | NA Participants |
| Cyclosporine Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Alanine aminotransferase (ALT), low | NA Participants |
| Cyclosporine Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Leukocytes, high | NA Participants |
| Cyclosporine Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | Leukocytes, low | 5 Participants |
| Cyclosporine Regimen | Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results | ALT, high | 7 Participants |
Other Pre-specified
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
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. Treatment-related=having certain, probable, possible, or missing relationship to study drug.
Time frame: Day 1 (posttransplant) continuously to 56 days following last dose of study medication
Population: All randomized participants who underwent transplantation and who received treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | SAEs | 50 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | AEs | 73 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Discontinuations due to SAEs | 13 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Deaths | 0 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Discontinuations due to AEs | 13 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Treatment-related AEs | 43 Participants |
| Belatacept: More Intensive (MI) Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Treatment-related SAEs | 21 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Discontinuations due to SAEs | 14 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Deaths | 0 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | SAEs | 52 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Treatment-related SAEs | 23 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | AEs | 69 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Treatment-related AEs | 40 Participants |
| Belatacept: Less Intensive (LI) Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Discontinuations due to AEs | 15 Participants |
| Cyclosporine Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | AEs | 68 Participants |
| Cyclosporine Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | SAEs | 42 Participants |
| Cyclosporine Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Discontinuations due to AEs | 14 Participants |
| Cyclosporine Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Treatment-related AEs | 50 Participants |
| Cyclosporine Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Discontinuations due to SAEs | 10 Participants |
| Cyclosporine Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Treatment-related SAEs | 21 Participants |
| Cyclosporine Regimen | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs | Deaths | 2 Participants |