Kidney Transplantation
Conditions
Brief summary
The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.
Interventions
DRUGBelatacept
DRUGTacrolimus
DRUGCyclosporine
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Men and women, ages 18-75 inclusive * Adult recipients of a renal allograft from a living donor or a deceased donor between 6-60 months prior to enrollment * Receiving a stable (≥1 month) regimen of Calcineurin inhibitor (CNI) \[Cyclosporine A (CsA) or Tacrolimus (TAC)\] with Mycophenolate mofetil (MMF) or Enteric Coated Mycophenolate Sodium (EC-MPS)/Mycophenolic acid (MPA), and corticosteroids * Stable renal function for 12 weeks prior to enrollment without new onset proteinuria * Calculated glomerular filtration rate (cGFR) ≥30 and ≤75 mL/min/1.73 m2 \[Modification of Diet in Renal Disease study (MDRD) 4-formula\]
Exclusion criteria
* Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown * History of acute rejection (AR) within 3 months prior to enrollment * History of antibody mediated rejection * Positive T-cell lymphocytotoxic cross match * Proteinuria \>1 g/day or \>0.5 g/day if diabetic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Survive With a Functional Graft at 24 Months | at 24 Months | Percentage of participants who survive with a functional graft at 24 months post-randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure | at 12 and 24 months | Mean change in systolic and diastolic blood pressure from baseline to 12 and 24 months post randomization |
| Number of Antihypertensive Medications Used to Control Hypertension | at baseline, 12 and 24 Months | The total number of antihypertensive medications used to control hypertension |
| Percentage of Participants Who Survive With a Functional Graft at 12 Months | at 12 Months | Percentage of participants who survive with a functional graft at 12 months post-randomization |
| Number of Participants With a Biopsy Proven Acute Rejection (BPAR) | at 12 and 24 Months | The number of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization includes participants with at least one cellular and/or humoral BPAR event. |
| Number of Participants With Varying Severity of BPAR | at 12 and 24 months | Number of participants in each severity of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization |
| Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change | at 12 and 24 months | Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Percent Change |
| Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change | at 12 and 24 months | Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Adjusted Change |
| Mean Calculated Glomerular Filtration Rate (cGFR) | up to 24 months | Mean cGFR by study visit, as calculated by the 4-variable MDRD equation. |
| Mean Urine Protein/ Creatinine Ratio (UPCR) | Up to 24 Months | Urine protein/ creatinine ratio (UPCR) at baseline, 3, 6, 12 and 24 months post randomization |
| Slope Analysis of 1/Serum Creatinine | at 12 and 24 Months | Slopes of 1/serum creatinine as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization |
| Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR | at 12 and 24 Months | Percentage of participants with \> 5% and \>10% improvement over baseline cGFR, at 12 and 24 months post-randomization |
| Number of Participants With Donor Specific Antibodies (DSA) | at baseline, 12 and 24 months | Number of participants with donor specific antibodies (DSA) at Baseline/Day 1, and Months 12 and 24 post-randomization |
| Mean Number of Symptom Occurrence and Symptom Distress | up to 12 Months | The frequency of symptom occurrence and symptom distress as measured with the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59R (MTSOSD-59R) at baseline, Week 6, and Months 3, 6, and 12 post-randomization. Higher scores in the MTSOSD-59R indicate a greater symptom and symptom distress burden than lower scores. |
| Number of Participants With an Adverse Event of Special Interest | 24 Months | Number of participants with an adverse event of special interests. Adverse events of special interest include: Serious Infections, Post-Transplant Lymphoproliferative Disorder (PTLD), Progressive multifocal leukoencephalopathy (PML), Malignancies (other than PTLD) including non-melanoma skin carcinomas, Tuberculosis Infections, CNS infections, Viral Infections and Infusion related reactions. |
| Number of Participants With Marked Laboratory Abnormalities | 24 Months | Number of participants with Marked Laboratory Abnormalities |
| Mean Change From Baseline in Vital Signs: Heart Rate | at 12 and 24 months | The mean change from baseline in measured heart rate |
| Slope Analysis of cGFR | at 12 and 24 Months | Slopes of cGFR as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization |
Countries
Argentina, Austria, Colombia, France, Germany, Netherlands, Norway, Sweden, Switzerland, United States
Participant flow
Pre-assignment details
446 Enrolled and Treated
Participants by arm
| Arm | Count |
|---|---|
| Belatacept Participants who converted to belatacept treatment from CNI-Based | 223 |
| CNI-Based Regimen Participants who continued on CNI-Based regimens | 223 |
| Total | 446 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Randomization | Not Treated | 2 | 1 |
| Treatment Period | Adverse Event | 12 | 7 |
| Treatment Period | Death | 3 | 3 |
| Treatment Period | Lack of Efficacy | 1 | 0 |
| Treatment Period | No longer meets study criteria | 3 | 10 |
| Treatment Period | poor/non compliance | 0 | 3 |
| Treatment Period | request to discontinue | 6 | 11 |
| Treatment Period | withdrew consent | 1 | 2 |
Baseline characteristics
| Characteristic | CNI-Based Regimen | Total | Belatacept |
|---|---|---|---|
| Age, Continuous | 54.0 Years STANDARD_DEVIATION 11.7 | 54.0 Years STANDARD_DEVIATION 11.5 | 55.0 Years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 24 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants | 161 Participants | 82 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 129 Participants | 261 Participants | 132 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 48 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 16 Participants | 7 Participants |
| Race (NIH/OMB) White | 187 Participants | 378 Participants | 191 Participants |
| Sex: Female, Male Female | 72 Participants | 145 Participants | 73 Participants |
| Sex: Female, Male Male | 151 Participants | 301 Participants | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 221 | 5 / 222 |
| other Total, other adverse events | 174 / 221 | 168 / 222 |
| serious Total, serious adverse events | 107 / 221 | 95 / 222 |
Outcome results
Primary
Percentage of Participants Who Survive With a Functional Graft at 24 Months
Percentage of participants who survive with a functional graft at 24 months post-randomization
Time frame: at 24 Months
Population: All Randomized Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belatacept | Percentage of Participants Who Survive With a Functional Graft at 24 Months | 98.2 Percentage |
| CNI-Based Regimen | Percentage of Participants Who Survive With a Functional Graft at 24 Months | 97.3 Percentage |
95% CI: [-8.6, 10.4]
Secondary
Mean Calculated Glomerular Filtration Rate (cGFR)
Mean cGFR by study visit, as calculated by the 4-variable MDRD equation.
Time frame: up to 24 months
Population: All Randomized Participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Belatacept | Mean Calculated Glomerular Filtration Rate (cGFR) | Baseline | 49.6 mL/min/1.73m² |
| Belatacept | Mean Calculated Glomerular Filtration Rate (cGFR) | Month 12 | 55.5 mL/min/1.73m² |
| Belatacept | Mean Calculated Glomerular Filtration Rate (cGFR) | Month 6 | 53.3 mL/min/1.73m² |
| Belatacept | Mean Calculated Glomerular Filtration Rate (cGFR) | Month 18 | 56.5 mL/min/1.73m² |
| Belatacept | Mean Calculated Glomerular Filtration Rate (cGFR) | Month 3 | 53.0 mL/min/1.73m² |
| Belatacept | Mean Calculated Glomerular Filtration Rate (cGFR) | Month 24 | 55.7 mL/min/1.73m² |
| Belatacept | Mean Calculated Glomerular Filtration Rate (cGFR) | Month 9 | 53.7 mL/min/1.73m² |
| Belatacept | Mean Calculated Glomerular Filtration Rate (cGFR) | Screening | 49.8 mL/min/1.73m² |
| CNI-Based Regimen | Mean Calculated Glomerular Filtration Rate (cGFR) | Baseline | 50.7 mL/min/1.73m² |
| CNI-Based Regimen | Mean Calculated Glomerular Filtration Rate (cGFR) | Screening | 49.7 mL/min/1.73m² |
| CNI-Based Regimen | Mean Calculated Glomerular Filtration Rate (cGFR) | Month 3 | 50.2 mL/min/1.73m² |
| CNI-Based Regimen | Mean Calculated Glomerular Filtration Rate (cGFR) | Month 6 | 50.9 mL/min/1.73m² |
| CNI-Based Regimen | Mean Calculated Glomerular Filtration Rate (cGFR) | Month 9 | 50.7 mL/min/1.73m² |
| CNI-Based Regimen | Mean Calculated Glomerular Filtration Rate (cGFR) | Month 12 | 50.5 mL/min/1.73m² |
| CNI-Based Regimen | Mean Calculated Glomerular Filtration Rate (cGFR) | Month 18 | 51.3 mL/min/1.73m² |
| CNI-Based Regimen | Mean Calculated Glomerular Filtration Rate (cGFR) | Month 24 | 51.1 mL/min/1.73m² |
Secondary
Mean Change From Baseline in Systolic and Diastolic Blood Pressure
Mean change in systolic and diastolic blood pressure from baseline to 12 and 24 months post randomization
Time frame: at 12 and 24 months
Population: All Randomized Participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Belatacept | Mean Change From Baseline in Systolic and Diastolic Blood Pressure | Diastolic BP at 12 Months | -1.5 mmHg |
| Belatacept | Mean Change From Baseline in Systolic and Diastolic Blood Pressure | Diastolic BP at 24 Months | -1.7 mmHg |
| Belatacept | Mean Change From Baseline in Systolic and Diastolic Blood Pressure | Systolic BP at 12 Months | -1.6 mmHg |
| Belatacept | Mean Change From Baseline in Systolic and Diastolic Blood Pressure | Systolic BP at 24 Months | -1.3 mmHg |
| CNI-Based Regimen | Mean Change From Baseline in Systolic and Diastolic Blood Pressure | Systolic BP at 24 Months | 1.2 mmHg |
| CNI-Based Regimen | Mean Change From Baseline in Systolic and Diastolic Blood Pressure | Diastolic BP at 12 Months | -0.6 mmHg |
| CNI-Based Regimen | Mean Change From Baseline in Systolic and Diastolic Blood Pressure | Systolic BP at 12 Months | 0.1 mmHg |
| CNI-Based Regimen | Mean Change From Baseline in Systolic and Diastolic Blood Pressure | Diastolic BP at 24 Months | 0.5 mmHg |
Secondary
Mean Change From Baseline in Vital Signs: Heart Rate
The mean change from baseline in measured heart rate
Time frame: at 12 and 24 months
Population: All Randomized and Treated Participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Belatacept | Mean Change From Baseline in Vital Signs: Heart Rate | Change from baseline at 12 months | -1.8 beats per minute (bpm) |
| Belatacept | Mean Change From Baseline in Vital Signs: Heart Rate | Change from baseline at 24 months | -1.9 beats per minute (bpm) |
| CNI-Based Regimen | Mean Change From Baseline in Vital Signs: Heart Rate | Change from baseline at 12 months | -0.6 beats per minute (bpm) |
| CNI-Based Regimen | Mean Change From Baseline in Vital Signs: Heart Rate | Change from baseline at 24 months | 1.0 beats per minute (bpm) |
Secondary
Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change
Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Adjusted Change
Time frame: at 12 and 24 months
Population: All Randomized Participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Belatacept | Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change | at 12 Months | 5.6 mL/min/1.73m² |
| Belatacept | Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change | at 24 Months | 6.2 mL/min/1.73m² |
| CNI-Based Regimen | Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change | at 12 Months | -0.7 mL/min/1.73m² |
| CNI-Based Regimen | Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change | at 24 Months | -1.0 mL/min/1.73m² |
Secondary
Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change
Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Percent Change
Time frame: at 12 and 24 months
Population: All Randomized Participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Belatacept | Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change | at 12 Months | 13.2 Percent Change |
| Belatacept | Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change | at 24 Months | 15.2 Percent Change |
| CNI-Based Regimen | Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change | at 12 Months | -0.3 Percent Change |
| CNI-Based Regimen | Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change | at 24 Months | 0.3 Percent Change |
Secondary
Mean Number of Symptom Occurrence and Symptom Distress
The frequency of symptom occurrence and symptom distress as measured with the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59R (MTSOSD-59R) at baseline, Week 6, and Months 3, 6, and 12 post-randomization. Higher scores in the MTSOSD-59R indicate a greater symptom and symptom distress burden than lower scores.
Time frame: up to 12 Months
Population: All randomized and Treated Participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belatacept | Mean Number of Symptom Occurrence and Symptom Distress | Baseline symptom occurrence | 87.8 Scores on a scale | Standard Deviation 20.06 |
| Belatacept | Mean Number of Symptom Occurrence and Symptom Distress | Baseline symptom distress | 28.7 Scores on a scale | Standard Deviation 27.07 |
| Belatacept | Mean Number of Symptom Occurrence and Symptom Distress | week 6 symptom occurrence | 79.0 Scores on a scale | Standard Deviation 16.52 |
| Belatacept | Mean Number of Symptom Occurrence and Symptom Distress | week 6 symptom distress | 19.8 Scores on a scale | Standard Deviation 21.41 |
| Belatacept | Mean Number of Symptom Occurrence and Symptom Distress | Month 3 symptom occurrence | 80.5 Scores on a scale | Standard Deviation 16.74 |
| Belatacept | Mean Number of Symptom Occurrence and Symptom Distress | Month 3 symptom distress | 21.4 Scores on a scale | Standard Deviation 23.08 |
| Belatacept | Mean Number of Symptom Occurrence and Symptom Distress | month 6 symptom occurrence | 80.5 Scores on a scale | Standard Deviation 17.5 |
| Belatacept | Mean Number of Symptom Occurrence and Symptom Distress | month 6 symptom distress | 22.4 Scores on a scale | Standard Deviation 22.18 |
| Belatacept | Mean Number of Symptom Occurrence and Symptom Distress | month 12 symptom occurrence | 82.3 Scores on a scale | Standard Deviation 20.08 |
| Belatacept | Mean Number of Symptom Occurrence and Symptom Distress | month 12 symptom distress | 25.8 Scores on a scale | Standard Deviation 25.32 |
| CNI-Based Regimen | Mean Number of Symptom Occurrence and Symptom Distress | month 6 symptom distress | 36.3 Scores on a scale | Standard Deviation 31.39 |
| CNI-Based Regimen | Mean Number of Symptom Occurrence and Symptom Distress | Baseline symptom occurrence | 90.7 Scores on a scale | Standard Deviation 21.04 |
| CNI-Based Regimen | Mean Number of Symptom Occurrence and Symptom Distress | Month 3 symptom distress | 35.2 Scores on a scale | Standard Deviation 32.04 |
| CNI-Based Regimen | Mean Number of Symptom Occurrence and Symptom Distress | Baseline symptom distress | 34.8 Scores on a scale | Standard Deviation 28.3 |
| CNI-Based Regimen | Mean Number of Symptom Occurrence and Symptom Distress | month 12 symptom distress | 34.4 Scores on a scale | Standard Deviation 30.82 |
| CNI-Based Regimen | Mean Number of Symptom Occurrence and Symptom Distress | week 6 symptom occurrence | 88.6 Scores on a scale | Standard Deviation 21.36 |
| CNI-Based Regimen | Mean Number of Symptom Occurrence and Symptom Distress | month 6 symptom occurrence | 91.8 Scores on a scale | Standard Deviation 23.72 |
| CNI-Based Regimen | Mean Number of Symptom Occurrence and Symptom Distress | week 6 symptom distress | 32.4 Scores on a scale | Standard Deviation 29.55 |
| CNI-Based Regimen | Mean Number of Symptom Occurrence and Symptom Distress | month 12 symptom occurrence | 91.0 Scores on a scale | Standard Deviation 22.33 |
| CNI-Based Regimen | Mean Number of Symptom Occurrence and Symptom Distress | Month 3 symptom occurrence | 89.9 Scores on a scale | Standard Deviation 23.45 |
Secondary
Mean Urine Protein/ Creatinine Ratio (UPCR)
Urine protein/ creatinine ratio (UPCR) at baseline, 3, 6, 12 and 24 months post randomization
Time frame: Up to 24 Months
Population: All Randomized Participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Belatacept | Mean Urine Protein/ Creatinine Ratio (UPCR) | at 3 months | 22.87 mg/mmol |
| Belatacept | Mean Urine Protein/ Creatinine Ratio (UPCR) | at 12 months | 29.11 mg/mmol |
| Belatacept | Mean Urine Protein/ Creatinine Ratio (UPCR) | at 6 months | 23.42 mg/mmol |
| Belatacept | Mean Urine Protein/ Creatinine Ratio (UPCR) | at 24 months | 28.81 mg/mmol |
| Belatacept | Mean Urine Protein/ Creatinine Ratio (UPCR) | at Baseline | 17.80 mg/mmol |
| CNI-Based Regimen | Mean Urine Protein/ Creatinine Ratio (UPCR) | at 24 months | 24.56 mg/mmol |
| CNI-Based Regimen | Mean Urine Protein/ Creatinine Ratio (UPCR) | at Baseline | 18.61 mg/mmol |
| CNI-Based Regimen | Mean Urine Protein/ Creatinine Ratio (UPCR) | at 3 months | 20.61 mg/mmol |
| CNI-Based Regimen | Mean Urine Protein/ Creatinine Ratio (UPCR) | at 6 months | 20.85 mg/mmol |
| CNI-Based Regimen | Mean Urine Protein/ Creatinine Ratio (UPCR) | at 12 months | 21.67 mg/mmol |
Secondary
Number of Antihypertensive Medications Used to Control Hypertension
The total number of antihypertensive medications used to control hypertension
Time frame: at baseline, 12 and 24 Months
Population: All Randomized Participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Belatacept | Number of Antihypertensive Medications Used to Control Hypertension | at Baseline | 2.1 Number of medications |
| Belatacept | Number of Antihypertensive Medications Used to Control Hypertension | at 12 Months | 2.3 Number of medications |
| Belatacept | Number of Antihypertensive Medications Used to Control Hypertension | at 24 Months | 2.3 Number of medications |
| CNI-Based Regimen | Number of Antihypertensive Medications Used to Control Hypertension | at Baseline | 2.2 Number of medications |
| CNI-Based Regimen | Number of Antihypertensive Medications Used to Control Hypertension | at 12 Months | 2.2 Number of medications |
| CNI-Based Regimen | Number of Antihypertensive Medications Used to Control Hypertension | at 24 Months | 2.3 Number of medications |
Secondary
Number of Participants With a Biopsy Proven Acute Rejection (BPAR)
The number of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization includes participants with at least one cellular and/or humoral BPAR event.
Time frame: at 12 and 24 Months
Population: All Randomized Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Belatacept | Number of Participants With a Biopsy Proven Acute Rejection (BPAR) | at 12 Months | 18 Participants |
| Belatacept | Number of Participants With a Biopsy Proven Acute Rejection (BPAR) | at 24 Months | 18 Participants |
| CNI-Based Regimen | Number of Participants With a Biopsy Proven Acute Rejection (BPAR) | at 12 Months | 4 Participants |
| CNI-Based Regimen | Number of Participants With a Biopsy Proven Acute Rejection (BPAR) | at 24 Months | 9 Participants |
Secondary
Number of Participants With an Adverse Event of Special Interest
Number of participants with an adverse event of special interests. Adverse events of special interest include: Serious Infections, Post-Transplant Lymphoproliferative Disorder (PTLD), Progressive multifocal leukoencephalopathy (PML), Malignancies (other than PTLD) including non-melanoma skin carcinomas, Tuberculosis Infections, CNS infections, Viral Infections and Infusion related reactions.
Time frame: 24 Months
Population: As Treated Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept | Number of Participants With an Adverse Event of Special Interest | Serious Infections | 37 participants |
| Belatacept | Number of Participants With an Adverse Event of Special Interest | PTLD | 1 participants |
| Belatacept | Number of Participants With an Adverse Event of Special Interest | PML | 0 participants |
| Belatacept | Number of Participants With an Adverse Event of Special Interest | Malignancies | 17 participants |
| Belatacept | Number of Participants With an Adverse Event of Special Interest | Tuberculosis infections | 0 participants |
| Belatacept | Number of Participants With an Adverse Event of Special Interest | CNS Infections | 0 participants |
| Belatacept | Number of Participants With an Adverse Event of Special Interest | Viral Infections | 5 participants |
| Belatacept | Number of Participants With an Adverse Event of Special Interest | Infusion Related Reactions | 13 participants |
| CNI-Based Regimen | Number of Participants With an Adverse Event of Special Interest | Infusion Related Reactions | 0 participants |
| CNI-Based Regimen | Number of Participants With an Adverse Event of Special Interest | Serious Infections | 44 participants |
| CNI-Based Regimen | Number of Participants With an Adverse Event of Special Interest | Tuberculosis infections | 0 participants |
| CNI-Based Regimen | Number of Participants With an Adverse Event of Special Interest | PTLD | 0 participants |
| CNI-Based Regimen | Number of Participants With an Adverse Event of Special Interest | Viral Infections | 9 participants |
| CNI-Based Regimen | Number of Participants With an Adverse Event of Special Interest | PML | 0 participants |
| CNI-Based Regimen | Number of Participants With an Adverse Event of Special Interest | CNS Infections | 0 participants |
| CNI-Based Regimen | Number of Participants With an Adverse Event of Special Interest | Malignancies | 12 participants |
Secondary
Number of Participants With Donor Specific Antibodies (DSA)
Number of participants with donor specific antibodies (DSA) at Baseline/Day 1, and Months 12 and 24 post-randomization
Time frame: at baseline, 12 and 24 months
Population: All Randomized Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Belatacept | Number of Participants With Donor Specific Antibodies (DSA) | Pre Existing at baseline | 10 Participants |
| Belatacept | Number of Participants With Donor Specific Antibodies (DSA) | De Novo at 12 Months | 2 Participants |
| Belatacept | Number of Participants With Donor Specific Antibodies (DSA) | De Novo at 24 Months | 2 Participants |
| CNI-Based Regimen | Number of Participants With Donor Specific Antibodies (DSA) | Pre Existing at baseline | 26 Participants |
| CNI-Based Regimen | Number of Participants With Donor Specific Antibodies (DSA) | De Novo at 12 Months | 9 Participants |
| CNI-Based Regimen | Number of Participants With Donor Specific Antibodies (DSA) | De Novo at 24 Months | 14 Participants |
Secondary
Number of Participants With Marked Laboratory Abnormalities
Number of participants with Marked Laboratory Abnormalities
Time frame: 24 Months
Population: All Randomized and Treated Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Hemoglobin (Abnormal Low) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Hemoglobin (Abnormal high) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Platelet count (Abnormal low) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Leukocytes (Abnormal low) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes (Abnormal low) | 29 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes (Abnormal high) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Neutrophils Absolute (Abnormal low) | 5 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Alanine Aminotransferase (Abnormal High) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Alkaline Phosphatase (Abnormal High) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Aspartate Aminotransferase (Abnormal High) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Total Bilirubin (Abnormal High) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Creatine (Abnormal High) | 5 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Protein/Creatinine Ratio (Abnormal High) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Bicarbonate (Abnormal High) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Total Calcium (Abnormal low) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Total Calcium (Abnormal high) | 1 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Magnesium (Abnormal low) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Magnesium (Abnormal high) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Phosphorus (Abnormal Low) | 14 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Potassium (Abnormal low) | 3 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Potassium (Abnormal high) | 1 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Sodium (Abnormal low) | 4 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Sodium (Abnormal high) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Albumin (Abnormal low) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Total Cholesterol (Abnormal High) | 13 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Serum Glucose (Abnormal low) | 0 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Serum Glucose (Abnormal high) | 18 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Triglycerides (Abnormal high) | 2 Participants |
| Belatacept | Number of Participants With Marked Laboratory Abnormalities | Uric Acid (Abnormal high) | 15 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Total Calcium (Abnormal low) | 3 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Hemoglobin (Abnormal Low) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Serum Glucose (Abnormal low) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Hemoglobin (Abnormal high) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Total Calcium (Abnormal high) | 2 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Platelet count (Abnormal low) | 1 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Sodium (Abnormal high) | 1 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Leukocytes (Abnormal low) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Magnesium (Abnormal low) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes (Abnormal low) | 10 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Triglycerides (Abnormal high) | 2 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes (Abnormal high) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Magnesium (Abnormal high) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Neutrophils Absolute (Abnormal low) | 3 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Albumin (Abnormal low) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Alanine Aminotransferase (Abnormal High) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Phosphorus (Abnormal Low) | 12 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Alkaline Phosphatase (Abnormal High) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Serum Glucose (Abnormal high) | 18 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Aspartate Aminotransferase (Abnormal High) | 1 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Potassium (Abnormal low) | 2 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Total Bilirubin (Abnormal High) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Total Cholesterol (Abnormal High) | 17 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Creatine (Abnormal High) | 4 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Potassium (Abnormal high) | 5 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Protein/Creatinine Ratio (Abnormal High) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Uric Acid (Abnormal high) | 30 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Bicarbonate (Abnormal High) | 1 Participants |
| CNI-Based Regimen | Number of Participants With Marked Laboratory Abnormalities | Sodium (Abnormal low) | 9 Participants |
Secondary
Number of Participants With Varying Severity of BPAR
Number of participants in each severity of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization
Time frame: at 12 and 24 months
Population: All Randomized Participants who had a BPAR
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Belatacept | Number of Participants With Varying Severity of BPAR | at 12 Months | Mild Acute (IA) | 2 Participants |
| Belatacept | Number of Participants With Varying Severity of BPAR | at 12 Months | Mild Acute (IB)1 | 1 Participants |
| Belatacept | Number of Participants With Varying Severity of BPAR | at 12 Months | Moderate Acute (IIA) | 7 Participants |
| Belatacept | Number of Participants With Varying Severity of BPAR | at 12 Months | Moderate Acute (IIB) | 6 Participants |
| Belatacept | Number of Participants With Varying Severity of BPAR | at 12 Months | Severe Acute (III) | 4 Participants |
| Belatacept | Number of Participants With Varying Severity of BPAR | at 24 Months | Mild Acute (IA) | 2 Participants |
| Belatacept | Number of Participants With Varying Severity of BPAR | at 24 Months | Mild Acute (IB)1 | 1 Participants |
| Belatacept | Number of Participants With Varying Severity of BPAR | at 24 Months | Moderate Acute (IIA) | 7 Participants |
| Belatacept | Number of Participants With Varying Severity of BPAR | at 24 Months | Moderate Acute (IIB) | 6 Participants |
| Belatacept | Number of Participants With Varying Severity of BPAR | at 24 Months | Severe Acute (III) | 4 Participants |
| CNI-Based Regimen | Number of Participants With Varying Severity of BPAR | at 24 Months | Moderate Acute (IIA) | 1 Participants |
| CNI-Based Regimen | Number of Participants With Varying Severity of BPAR | at 12 Months | Mild Acute (IA) | 2 Participants |
| CNI-Based Regimen | Number of Participants With Varying Severity of BPAR | at 24 Months | Mild Acute (IA) | 4 Participants |
| CNI-Based Regimen | Number of Participants With Varying Severity of BPAR | at 12 Months | Mild Acute (IB)1 | 0 Participants |
| CNI-Based Regimen | Number of Participants With Varying Severity of BPAR | at 24 Months | Severe Acute (III) | 1 Participants |
| CNI-Based Regimen | Number of Participants With Varying Severity of BPAR | at 12 Months | Moderate Acute (IIA) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Varying Severity of BPAR | at 24 Months | Mild Acute (IB)1 | 0 Participants |
| CNI-Based Regimen | Number of Participants With Varying Severity of BPAR | at 12 Months | Moderate Acute (IIB) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Varying Severity of BPAR | at 24 Months | Moderate Acute (IIB) | 0 Participants |
| CNI-Based Regimen | Number of Participants With Varying Severity of BPAR | at 12 Months | Severe Acute (III) | 1 Participants |
Secondary
Percentage of Participants Who Survive With a Functional Graft at 12 Months
Percentage of participants who survive with a functional graft at 12 months post-randomization
Time frame: at 12 Months
Population: All Randomized Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belatacept | Percentage of Participants Who Survive With a Functional Graft at 12 Months | 98.7 Percentage |
| CNI-Based Regimen | Percentage of Participants Who Survive With a Functional Graft at 12 Months | 99.1 Percentage |
95% CI: [-9.9, 9]
Secondary
Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR
Percentage of participants with \> 5% and \>10% improvement over baseline cGFR, at 12 and 24 months post-randomization
Time frame: at 12 and 24 Months
Population: All Randomized Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept | Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR | >5% improvement at 12 months | 53.4 Percentage |
| Belatacept | Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR | >10% improvement at 12 months | 43.9 Percentage |
| Belatacept | Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR | >5% improvement at 24 months | 54.3 Percentage |
| Belatacept | Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR | >10% improvement at 24 months | 48.4 Percentage |
| CNI-Based Regimen | Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR | >10% improvement at 24 months | 22.0 Percentage |
| CNI-Based Regimen | Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR | >5% improvement at 12 months | 28.7 Percentage |
| CNI-Based Regimen | Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR | >5% improvement at 24 months | 29.6 Percentage |
| CNI-Based Regimen | Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR | >10% improvement at 12 months | 21.5 Percentage |
Secondary
Slope Analysis of 1/Serum Creatinine
Slopes of 1/serum creatinine as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization
Time frame: at 12 and 24 Months
Population: All Randomized Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept | Slope Analysis of 1/Serum Creatinine | Baseline to 12 Months | 0.034 mg/dL/month |
| Belatacept | Slope Analysis of 1/Serum Creatinine | Month 3 to Month 12 | 0.033 mg/dL/month |
| Belatacept | Slope Analysis of 1/Serum Creatinine | Baseline to Month 24 | 0.00868 mg/dL/month |
| Belatacept | Slope Analysis of 1/Serum Creatinine | Month 3 to Month 24 | 0.00814 mg/dL/month |
| CNI-Based Regimen | Slope Analysis of 1/Serum Creatinine | Month 3 to Month 24 | -0.00425 mg/dL/month |
| CNI-Based Regimen | Slope Analysis of 1/Serum Creatinine | Baseline to 12 Months | -0.003 mg/dL/month |
| CNI-Based Regimen | Slope Analysis of 1/Serum Creatinine | Baseline to Month 24 | -0.00203 mg/dL/month |
| CNI-Based Regimen | Slope Analysis of 1/Serum Creatinine | Month 3 to Month 12 | -0.021 mg/dL/month |
Secondary
Slope Analysis of cGFR
Slopes of cGFR as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization
Time frame: at 12 and 24 Months
Population: All Randomized Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept | Slope Analysis of cGFR | Baseline to 12 Months | 0.241 mL/min/1.73m²/month |
| Belatacept | Slope Analysis of cGFR | Month 3 to Month 12 | 0.281 mL/min/1.73m²/month |
| Belatacept | Slope Analysis of cGFR | Baseline to Month 24 | 0.685 mL/min/1.73m²/month |
| Belatacept | Slope Analysis of cGFR | Month 3 to Month 24 | 0.658 mL/min/1.73m²/month |
| CNI-Based Regimen | Slope Analysis of cGFR | Month 3 to Month 24 | -0.277 mL/min/1.73m²/month |
| CNI-Based Regimen | Slope Analysis of cGFR | Baseline to 12 Months | 0.004 mL/min/1.73m²/month |
| CNI-Based Regimen | Slope Analysis of cGFR | Baseline to Month 24 | -0.112 mL/min/1.73m²/month |
| CNI-Based Regimen | Slope Analysis of cGFR | Month 3 to Month 12 | -0.159 mL/min/1.73m²/month |