Kidney Transplantation
Conditions
Brief summary
Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress the immune system (called immunosuppressive regimens) to stop the immune system from attacking the transplanted kidney in order to limit damage to or the possibility of rejecting the transplanted kidney. The purpose of this study is to evaluate benefits and risks of two immunosuppressive regimens (belatacept with everolimus or tacrolimus with mycophenolate mofetil) following thymoglobulin induction and rapid corticosteroid withdrawal.
Detailed description
Calcineurin inhibitor (CNI)
Interventions
DRUGThymoglobulin
DRUGBelatacept
DRUGCorticosteroids
DRUGEverolimus(EVL)
DRUGTacrolimus(TAC)
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, aged 18 to 75 * Serologic test results are positive for past exposure to Epstein Barr Virus (EBV+) * Diagnosed with end stage renal disease (ESRD) and scheduled to undergo transplantation of a non-HLA identical, living or standard criteria deceased donor kidney
Exclusion criteria
* Primary cause of ESRD is: primary focal segmental glomerulosclerosis; or Type I or II membranoproliferative glomerulonephritis; or Hemolytic Uremic Syndrome / Thrombotic Thrombocytopenic Purpura * Had a previous graft loss due to acute rejection * At increased immunologic risk of graft loss due to panel reactive antibodies (PRA) \>20% or need for desensitization therapy * Scheduled to receive a: kidney from identical twin; or paired kidney; or kidney from a Cytomegalovirus(CMV) positive donor when recipient is CMV negative; or kidney from an extended criteria donor * Have a body mass index (BMI) of \> 35 kg/m2 for nondiabetics or \> 30 kg/m2 for diabetics * Diagnosed as Hepatitis B positive; or Hepatitis C positive; or HIV positive; or currently or previously active or inadequately treated latent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months | 6 Months | Number of Participants with Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR). | Up to 24 Months | Time to Clinically suspected biopsy proven acute rejection |
| Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | At 6, 12 and 24 Months | Treatment differences in the severity grades to treat all episodes of CSBPAR at 6, 12, and 24 months post-transplant. Type 1A - Cases with significant interstitial infiltration (\>25% of parenchyma affected) and foci of moderate tubulitis (\>4 mononuclear cells/Tubular cross section or group of 10 Tubular cell). Type 1B - Cases with significant interstitial infiltration (\>25% of parenchyma affected) and foci of moderate tubulitis (\>10 mononuclear cells/Tubular cross section or group of 10 Tubular cell).Type 2A - Cases with mild to moderate intimal arteritis.Type 2B - Cases with severe intimal arteritis comprising \>25% of the luminal area. Type 3 - Cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (v3 with accompanying lymphocytic inflammation) |
| Treatment Differences in Therapeutic Modalities | at 6, 12 and 24 Months | Treatment Received for Biopsy Proven Acute Rejection (Banff Grade IA or Higher), or Humoral (Antibody Mediated) Rejection Treatment regimen: Categorical analysis of CSBPAR episodes by treatment received. |
| Number of Participants Who Survive With a Functioning Graft | At 6, 12 and 24 months | Number of all participants who survive with a functioning graft at 6, 12 and 24 months post transplant |
| Number of Participants Deaths Post Transplant | up to 24 months | Number of participant deaths at 6, 12 and 24 months post transplant |
| Number of Participants Who Experience Graft Loss Post Transplant | At 6, 12 and 24 months | Number of all participants who experience graft loss at 6, 12 and 24 months post transplant |
| Time to Event: Graft Loss and Death | Up to 728 Days | The Number of days to participant Graft Loss and death for any reason |
| Absolute Calculated Glomerular Filtration Rate (cGFR): Mean | Up 24 Months post-transplant | Absolute (mean and median) cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula |
| Median Calculated Glomerular Filtration Rate (cGFR) | Up 24 Months post-transplant | Median cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula |
| Mean Change From Month 3 in cGFR | Up 24 Months post-transplant | The mean change from Month 3 cGFR at 3, 6, 12 and 24 months post-transplant |
| Urine Protein Creatinine Ratio (UPr/Cr) | Up 24 Months post-transplant | Urine protein to creatinine ratio (UPr/Cr) at 3, 6, 12 and 24 months post-transplant. |
| Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | Up to 24 Months | Percentage of participants with, and titers of pre-existing (pre-transplant) DSA on Day 1 (pre-transplant, pre-dose), and at Months 12 and 24 posttransplant |
| Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | Up to 24 Months | Characterization of any de novo DSA detected by IgM and IgG subclasses, and by the presence or absence of complement fixing properties. |
| Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months | Up to 24 Months | Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6, 12 and 24 Months Change in the incidence of CSBPAR at 6, 12 and 24 months post transplant, in the belatacept + EVL(Treatment A) as compared to TAC + MMF (Treatment B). |
| Percentage of Participants With Serious Adverse Events (SAEs) | Up to 24 months Post-Transplant | Percentage of participants with SAEs up to 24 months post-transplant |
| Percentage of Participants With Events of Special Interest (ESIs) | Up to 24 Months | Percentage of participants which have one of the following events of special interest: Serious Infections Post-Transplant Lymphoproliferative Disorder (PTLD) Progressive multifocal leukoencephalopathy (PML) Malignancies (Other than PTLD) including non-melanoma skin carcinomas (Malignancies) Tuberculosis Infections Central Nervous System (CNS) Infections Viral Infections Infusion Related reactions within 24 hours since belatacept infusion |
| Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | At 24 Months | Percentage of participants with laboratory tests with marked laboratory abnormalities |
| Mean and Mean Change From Baseline in Blood Glucose | Up to 24 months | Mean fasting blood glucose levels, and mean changes from baseline values at Months 6, 12 and 24 months post- transplant |
| Mean and Mean Change From Baseline in Whole Blood HbA1c | Up to 24 months | Mean whole blood HbA1C concentrations, and mean changes from baseline values at Months 6, 12 and 24 months post-transplant. |
| Percentage of Participants With New Onset Diabetes After Transplant | up to 24 months | Percentage of participants with New Onset Diabetes After Transplantation (NODAT) at 6, 12, and 24 months post-transplant. |
| Absolute Values of Blood Pressure: Mean | Up to 24 Months | Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant; |
| Absolute Values of Blood Pressure: Median | Up to 24 Months | Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant; |
| Mean Changes From Baseline Values for Blood Pressure | Up to 24 Months | Mean changes from baseline values for SBP and DBP at 6, 12 and 24 months post-transplant |
| Absolute Values of Fasting Lipid Values: Mean | Up to 24 Months | Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG) |
| Absolute Values of Fasting Lipid Values: Median | Up to 24 Months | Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG) |
| Mean Changes From Baseline Values of Lipid Values | at months 12 and 24 | Mean changes from baseline values in the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG) |
| Percentage of Participants With Adverse Events (AEs) | Up to 24 months Post-Transplant | Percentage of participants with AEs up to 24 months post-transplant |
Countries
Argentina, United States
Participant flow
Pre-assignment details
58 participants randomized and treated
Participants by arm
| Arm | Count |
|---|---|
| Treatment A BELA + EVL | 26 |
| Treatment B TAC + MMF | 32 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Discontinued Study Treatment | 0 | 3 |
| Overall Study | Withdrew Consent | 1 | 1 |
Baseline characteristics
| Characteristic | Treatment A | Treatment B | Total |
|---|---|---|---|
| Age, Continuous | 51.7 Years STANDARD_DEVIATION 12.8 | 50.8 Years STANDARD_DEVIATION 10.9 | 51.2 Years STANDARD_DEVIATION 11.7 |
| Age, Customized < 65 | 22 Participants | 28 Participants | 50 Participants |
| Age, Customized ≥ 65 | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 9 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 | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 23 Participants | 21 Participants | 44 Participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 21 Participants | 23 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 33 |
| other Total, other adverse events | 25 / 25 | 30 / 33 |
| serious Total, serious adverse events | 13 / 25 | 20 / 33 |
Outcome results
Primary
Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months
Number of Participants with Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6 Months
Time frame: 6 Months
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A | Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months | 7.7 Percentage of participants |
| Treatment B | Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months | 9.4 Percentage of participants |
Secondary
Absolute Calculated Glomerular Filtration Rate (cGFR): Mean
Absolute (mean and median) cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula
Time frame: Up 24 Months post-transplant
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment A | Absolute Calculated Glomerular Filtration Rate (cGFR): Mean | At 3 Months | 69.2 mL/min/1.73 m^2 |
| Treatment A | Absolute Calculated Glomerular Filtration Rate (cGFR): Mean | At 12 Months | 66.2 mL/min/1.73 m^2 |
| Treatment A | Absolute Calculated Glomerular Filtration Rate (cGFR): Mean | At 6 Months | 66.0 mL/min/1.73 m^2 |
| Treatment A | Absolute Calculated Glomerular Filtration Rate (cGFR): Mean | At 24 Months | 71.8 mL/min/1.73 m^2 |
| Treatment B | Absolute Calculated Glomerular Filtration Rate (cGFR): Mean | At 24 Months | 68.7 mL/min/1.73 m^2 |
| Treatment B | Absolute Calculated Glomerular Filtration Rate (cGFR): Mean | At 3 Months | 62.2 mL/min/1.73 m^2 |
| Treatment B | Absolute Calculated Glomerular Filtration Rate (cGFR): Mean | At 6 Months | 63.9 mL/min/1.73 m^2 |
| Treatment B | Absolute Calculated Glomerular Filtration Rate (cGFR): Mean | At 12 Months | 62.0 mL/min/1.73 m^2 |
Secondary
Absolute Values of Blood Pressure: Mean
Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant;
Time frame: Up to 24 Months
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment A | Absolute Values of Blood Pressure: Mean | Diastolic Month 3 | 78.7 mmHg |
| Treatment A | Absolute Values of Blood Pressure: Mean | Systolic Month 3 | 134.2 mmHg |
| Treatment A | Absolute Values of Blood Pressure: Mean | Diastolic Month 6 | 77.4 mmHg |
| Treatment A | Absolute Values of Blood Pressure: Mean | Systolic Month 6 | 128.1 mmHg |
| Treatment A | Absolute Values of Blood Pressure: Mean | Diastolic Month 12 | 78.7 mmHg |
| Treatment A | Absolute Values of Blood Pressure: Mean | Systolic Month 12 | 131.0 mmHg |
| Treatment A | Absolute Values of Blood Pressure: Mean | Diastolic Month 24 | 78.1 mmHg |
| Treatment A | Absolute Values of Blood Pressure: Mean | Systolic Month 24 | 130.9 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Mean | Systolic Month 24 | 131.7 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Mean | Diastolic Month 3 | 77.7 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Mean | Diastolic Month 12 | 80.1 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Mean | Systolic Month 3 | 131.0 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Mean | Diastolic Month 24 | 78.5 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Mean | Diastolic Month 6 | 79.4 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Mean | Systolic Month 12 | 131.0 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Mean | Systolic Month 6 | 133.0 mmHg |
Secondary
Absolute Values of Blood Pressure: Median
Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant;
Time frame: Up to 24 Months
Population: ITT Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment A | Absolute Values of Blood Pressure: Median | Systolic Month 24 | 130.0 mmHg |
| Treatment A | Absolute Values of Blood Pressure: Median | Diastolic Month 3 | 78.5 mmHg |
| Treatment A | Absolute Values of Blood Pressure: Median | Systolic Month 3 | 135.5 mmHg |
| Treatment A | Absolute Values of Blood Pressure: Median | Diastolic Month 6 | 75.5 mmHg |
| Treatment A | Absolute Values of Blood Pressure: Median | Systolic Month 6 | 127.0 mmHg |
| Treatment A | Absolute Values of Blood Pressure: Median | Diastolic Month 12 | 77.0 mmHg |
| Treatment A | Absolute Values of Blood Pressure: Median | Systolic Month 12 | 130.0 mmHg |
| Treatment A | Absolute Values of Blood Pressure: Median | Diastolic Month 24 | 78.0 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Median | Diastolic Month 24 | 79.0 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Median | Systolic Month 24 | 130.0 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Median | Systolic Month 6 | 131.0 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Median | Diastolic Month 3 | 80.0 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Median | Systolic Month 12 | 126.0 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Median | Systolic Month 3 | 131.0 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Median | Diastolic Month 12 | 81.0 mmHg |
| Treatment B | Absolute Values of Blood Pressure: Median | Diastolic Month 6 | 80.0 mmHg |
Secondary
Absolute Values of Fasting Lipid Values: Mean
Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)
Time frame: Up to 24 Months
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | TC Month 3 | 181.2 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | TC Month 6 | 197.7 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | TC Month 12 | 189.0 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | TC Month 24 | 193.2 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | HDL Month 3 | 50.6 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | HDL Month 6 | 46.4 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | HDL Month 12 | 49.4 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | HDL Month 24 | 50.1 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | LDL Month 3 | 96.9 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | LDL Month 6 | 115.2 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | LDL Month 12 | 107.5 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | LDL Month 24 | 97.9 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | TG Month 3 | 171.6 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | TG Month 6 | 180.0 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | TG Month 12 | 162.4 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Mean | TG Month 24 | 263.4 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | TG Month 24 | 145.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | TC Month 3 | 174.4 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | LDL Month 3 | 96.5 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | TC Month 6 | 175 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | TG Month 3 | 137.8 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | TC Month 12 | 169.9 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | LDL Month 6 | 93.7 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | TC Month 24 | 168.2 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | TG Month 12 | 161.3 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | HDL Month 3 | 50.4 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | LDL Month 12 | 88.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | HDL Month 6 | 53.9 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | TG Month 6 | 138.3 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | HDL Month 12 | 49.6 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | LDL Month 24 | 91.5 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Mean | HDL Month 24 | 51.3 mg/dL |
Secondary
Absolute Values of Fasting Lipid Values: Median
Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)
Time frame: Up to 24 Months
Population: ITT Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment A | Absolute Values of Fasting Lipid Values: Median | TC Month 12 | 184.0 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | HDL Month 24 | 49.0 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | TG Month 24 | 159.0 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | LDL Month 3 | 89.0 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | TC Month 24 | 193.0 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | LDL Month 6 | 99.5 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | TC Month 3 | 167.0 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | LDL Month 12 | 104.0 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | HDL Month 3 | 45.0 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | LDL Month 24 | 103.5 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | TC Month 6 | 187.0 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | TG Month 3 | 147.0 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | HDL Month 6 | 45.5 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | TG Month 12 | 154.0 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | TG Month 6 | 157.5 mg/dL |
| Treatment A | Absolute Values of Fasting Lipid Values: Median | HDL Month 12 | 50.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | TG Month 24 | 114.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | TG Month 6 | 126.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | TC Month 6 | 178.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | TC Month 12 | 171.5 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | TC Month 24 | 166.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | HDL Month 3 | 49.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | HDL Month 6 | 49.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | HDL Month 12 | 47.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | HDL Month 24 | 49.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | LDL Month 3 | 95.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | LDL Month 6 | 100.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | LDL Month 12 | 91.5 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | LDL Month 24 | 86.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | TG Month 3 | 128.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | TG Month 12 | 130.0 mg/dL |
| Treatment B | Absolute Values of Fasting Lipid Values: Median | TC Month 3 | 173.0 mg/dL |
Secondary
Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months
Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6, 12 and 24 Months Change in the incidence of CSBPAR at 6, 12 and 24 months post transplant, in the belatacept + EVL(Treatment A) as compared to TAC + MMF (Treatment B).
Time frame: Up to 24 Months
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months | CSBPAR at 6 Months | 7.7 Percentage of CSBPAR |
| Treatment A | Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months | CSBPAR at 12 months | 11.5 Percentage of CSBPAR |
| Treatment A | Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months | CSBPAR at 24 Months | 15.4 Percentage of CSBPAR |
| Treatment B | Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months | CSBPAR at 6 Months | 9.4 Percentage of CSBPAR |
| Treatment B | Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months | CSBPAR at 12 months | 12.5 Percentage of CSBPAR |
| Treatment B | Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months | CSBPAR at 24 Months | 12.5 Percentage of CSBPAR |
Comparison: Change in Incidence of Treatment A as compared to Treatment B at 6 Months95% CI: [-18.9, 16.7]
Comparison: Change in Incidence of Treatment A as compared to Treatment B at 12 Months95% CI: [-19.2, 18.9]
Comparison: Change in Incidence of Treatment A as compared to Treatment B at 24 Months95% CI: [-16.1, 23.9]
Secondary
Mean and Mean Change From Baseline in Blood Glucose
Mean fasting blood glucose levels, and mean changes from baseline values at Months 6, 12 and 24 months post- transplant
Time frame: Up to 24 months
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment A | Mean and Mean Change From Baseline in Blood Glucose | Mean Value at 6 months | 107.2 mg/dL |
| Treatment A | Mean and Mean Change From Baseline in Blood Glucose | Change from baseline at 6 months | 4.9 mg/dL |
| Treatment A | Mean and Mean Change From Baseline in Blood Glucose | Mean Value at 12 months | 101.1 mg/dL |
| Treatment A | Mean and Mean Change From Baseline in Blood Glucose | Change from baseline at 12 months | -1.3 mg/dL |
| Treatment A | Mean and Mean Change From Baseline in Blood Glucose | Mean Value at 24 months | 127.5 mg/dL |
| Treatment A | Mean and Mean Change From Baseline in Blood Glucose | Change from baseline at 24 months | 22.3 mg/dL |
| Treatment B | Mean and Mean Change From Baseline in Blood Glucose | Mean Value at 24 months | 111.8 mg/dL |
| Treatment B | Mean and Mean Change From Baseline in Blood Glucose | Mean Value at 6 months | 107.2 mg/dL |
| Treatment B | Mean and Mean Change From Baseline in Blood Glucose | Change from baseline at 12 months | 20.6 mg/dL |
| Treatment B | Mean and Mean Change From Baseline in Blood Glucose | Change from baseline at 6 months | 4.8 mg/dL |
| Treatment B | Mean and Mean Change From Baseline in Blood Glucose | Change from baseline at 24 months | 15.0 mg/dL |
| Treatment B | Mean and Mean Change From Baseline in Blood Glucose | Mean Value at 12 months | 127.5 mg/dL |
Secondary
Mean and Mean Change From Baseline in Whole Blood HbA1c
Mean whole blood HbA1C concentrations, and mean changes from baseline values at Months 6, 12 and 24 months post-transplant.
Time frame: Up to 24 months
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment A | Mean and Mean Change From Baseline in Whole Blood HbA1c | Change from baseline at 12 months | 0.47 mg/dL |
| Treatment A | Mean and Mean Change From Baseline in Whole Blood HbA1c | Mean Value at 12 months | 6.18 mg/dL |
| Treatment A | Mean and Mean Change From Baseline in Whole Blood HbA1c | Mean Value at 24 months | 6.24 mg/dL |
| Treatment A | Mean and Mean Change From Baseline in Whole Blood HbA1c | Change from baseline at 6 months | 0.34 mg/dL |
| Treatment A | Mean and Mean Change From Baseline in Whole Blood HbA1c | Change from baseline at 24 months | 0.66 mg/dL |
| Treatment A | Mean and Mean Change From Baseline in Whole Blood HbA1c | Mean Value at 6 months | 6.11 mg/dL |
| Treatment B | Mean and Mean Change From Baseline in Whole Blood HbA1c | Change from baseline at 24 months | 0.41 mg/dL |
| Treatment B | Mean and Mean Change From Baseline in Whole Blood HbA1c | Mean Value at 6 months | 6.13 mg/dL |
| Treatment B | Mean and Mean Change From Baseline in Whole Blood HbA1c | Mean Value at 12 months | 6.21 mg/dL |
| Treatment B | Mean and Mean Change From Baseline in Whole Blood HbA1c | Change from baseline at 12 months | 0.32 mg/dL |
| Treatment B | Mean and Mean Change From Baseline in Whole Blood HbA1c | Mean Value at 24 months | 6.29 mg/dL |
| Treatment B | Mean and Mean Change From Baseline in Whole Blood HbA1c | Change from baseline at 6 months | 0.48 mg/dL |
Secondary
Mean Change From Month 3 in cGFR
The mean change from Month 3 cGFR at 3, 6, 12 and 24 months post-transplant
Time frame: Up 24 Months post-transplant
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment A | Mean Change From Month 3 in cGFR | At 3 Months | 0 mL/min/1.73 m^2 |
| Treatment A | Mean Change From Month 3 in cGFR | At 6 Months | -3.2 mL/min/1.73 m^2 |
| Treatment A | Mean Change From Month 3 in cGFR | At 12 Months | -3.1 mL/min/1.73 m^2 |
| Treatment A | Mean Change From Month 3 in cGFR | At 24 Months | 3.1 mL/min/1.73 m^2 |
| Treatment B | Mean Change From Month 3 in cGFR | At 24 Months | 6.3 mL/min/1.73 m^2 |
| Treatment B | Mean Change From Month 3 in cGFR | At 3 Months | 0 mL/min/1.73 m^2 |
| Treatment B | Mean Change From Month 3 in cGFR | At 12 Months | 1.4 mL/min/1.73 m^2 |
| Treatment B | Mean Change From Month 3 in cGFR | At 6 Months | 2.8 mL/min/1.73 m^2 |
Secondary
Mean Changes From Baseline Values for Blood Pressure
Mean changes from baseline values for SBP and DBP at 6, 12 and 24 months post-transplant
Time frame: Up to 24 Months
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment A | Mean Changes From Baseline Values for Blood Pressure | Diastolic Month 6 | 1.0 mmHg |
| Treatment A | Mean Changes From Baseline Values for Blood Pressure | Systolic Month 6 | -4.0 mmHg |
| Treatment A | Mean Changes From Baseline Values for Blood Pressure | Diastolic Month 12 | 2.3 mmHg |
| Treatment A | Mean Changes From Baseline Values for Blood Pressure | Systolic Month 12 | -1.1 mmHg |
| Treatment A | Mean Changes From Baseline Values for Blood Pressure | Diastolic Month 24 | 0.9 mmHg |
| Treatment A | Mean Changes From Baseline Values for Blood Pressure | Systolic Month 24 | -2.3 mmHg |
| Treatment B | Mean Changes From Baseline Values for Blood Pressure | Diastolic Month 24 | 2.1 mmHg |
| Treatment B | Mean Changes From Baseline Values for Blood Pressure | Diastolic Month 6 | 4.8 mmHg |
| Treatment B | Mean Changes From Baseline Values for Blood Pressure | Systolic Month 12 | -3.2 mmHg |
| Treatment B | Mean Changes From Baseline Values for Blood Pressure | Systolic Month 6 | -0.7 mmHg |
| Treatment B | Mean Changes From Baseline Values for Blood Pressure | Systolic Month 24 | -4.2 mmHg |
| Treatment B | Mean Changes From Baseline Values for Blood Pressure | Diastolic Month 12 | 5.4 mmHg |
Secondary
Mean Changes From Baseline Values of Lipid Values
Mean changes from baseline values in the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)
Time frame: at months 12 and 24
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment A | Mean Changes From Baseline Values of Lipid Values | TC Month 12 | 25.7 mg/dL |
| Treatment A | Mean Changes From Baseline Values of Lipid Values | TC Month 24 | 26.6 mg/dL |
| Treatment A | Mean Changes From Baseline Values of Lipid Values | HDL Month 12 | 5.4 mg/dL |
| Treatment A | Mean Changes From Baseline Values of Lipid Values | HDL Month 24 | 6.2 mg/dL |
| Treatment A | Mean Changes From Baseline Values of Lipid Values | LDL Month 12 | 25.7 mg/dL |
| Treatment A | Mean Changes From Baseline Values of Lipid Values | LDL Month 24 | 17.4 mg/dL |
| Treatment A | Mean Changes From Baseline Values of Lipid Values | TG Month 12 | 3.3 mg/dL |
| Treatment A | Mean Changes From Baseline Values of Lipid Values | TG Month 24 | 106.8 mg/dL |
| Treatment B | Mean Changes From Baseline Values of Lipid Values | TG Month 24 | -13.6 mg/dL |
| Treatment B | Mean Changes From Baseline Values of Lipid Values | TC Month 12 | -2.8 mg/dL |
| Treatment B | Mean Changes From Baseline Values of Lipid Values | TG Month 12 | -86.1 mg/dL |
| Treatment B | Mean Changes From Baseline Values of Lipid Values | TC Month 24 | 10.0 mg/dL |
| Treatment B | Mean Changes From Baseline Values of Lipid Values | LDL Month 12 | 10.8 mg/dL |
| Treatment B | Mean Changes From Baseline Values of Lipid Values | HDL Month 12 | 1.9 mg/dL |
| Treatment B | Mean Changes From Baseline Values of Lipid Values | LDL Month 24 | 15.7 mg/dL |
| Treatment B | Mean Changes From Baseline Values of Lipid Values | HDL Month 24 | 4.8 mg/dL |
Secondary
Median Calculated Glomerular Filtration Rate (cGFR)
Median cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula
Time frame: Up 24 Months post-transplant
Population: ITT Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment A | Median Calculated Glomerular Filtration Rate (cGFR) | At 3 Months | 64.0 mL/min/1.73 m^2 |
| Treatment A | Median Calculated Glomerular Filtration Rate (cGFR) | At 6 Months | 64.0 mL/min/1.73 m^2 |
| Treatment A | Median Calculated Glomerular Filtration Rate (cGFR) | At 12 Months | 66.0 mL/min/1.73 m^2 |
| Treatment A | Median Calculated Glomerular Filtration Rate (cGFR) | At 24 Months | 73.5 mL/min/1.73 m^2 |
| Treatment B | Median Calculated Glomerular Filtration Rate (cGFR) | At 24 Months | 68.0 mL/min/1.73 m^2 |
| Treatment B | Median Calculated Glomerular Filtration Rate (cGFR) | At 3 Months | 62.0 mL/min/1.73 m^2 |
| Treatment B | Median Calculated Glomerular Filtration Rate (cGFR) | At 12 Months | 62.5 mL/min/1.73 m^2 |
| Treatment B | Median Calculated Glomerular Filtration Rate (cGFR) | At 6 Months | 67.0 mL/min/1.73 m^2 |
Secondary
Number of Participants Deaths Post Transplant
Number of participant deaths at 6, 12 and 24 months post transplant
Time frame: up to 24 months
Population: All Treated Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A | Number of Participants Deaths Post Transplant | At 6 Months | 0 Participants |
| Treatment A | Number of Participants Deaths Post Transplant | At 12 Months | 0 Participants |
| Treatment A | Number of Participants Deaths Post Transplant | At 24 Months | 0 Participants |
| Treatment B | Number of Participants Deaths Post Transplant | At 6 Months | 0 Participants |
| Treatment B | Number of Participants Deaths Post Transplant | At 12 Months | 0 Participants |
| Treatment B | Number of Participants Deaths Post Transplant | At 24 Months | 0 Participants |
Secondary
Number of Participants Who Experience Graft Loss Post Transplant
Number of all participants who experience graft loss at 6, 12 and 24 months post transplant
Time frame: At 6, 12 and 24 months
Population: ITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A | Number of Participants Who Experience Graft Loss Post Transplant | At 12 Months | 1 Participants |
| Treatment A | Number of Participants Who Experience Graft Loss Post Transplant | At 6 Months | 1 Participants |
| Treatment A | Number of Participants Who Experience Graft Loss Post Transplant | At 24 Months | 1 Participants |
| Treatment B | Number of Participants Who Experience Graft Loss Post Transplant | At 6 Months | 1 Participants |
| Treatment B | Number of Participants Who Experience Graft Loss Post Transplant | At 12 Months | 1 Participants |
| Treatment B | Number of Participants Who Experience Graft Loss Post Transplant | At 24 Months | 1 Participants |
Secondary
Number of Participants Who Survive With a Functioning Graft
Number of all participants who survive with a functioning graft at 6, 12 and 24 months post transplant
Time frame: At 6, 12 and 24 months
Population: All Treated Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A | Number of Participants Who Survive With a Functioning Graft | At 6 Months | 25 Participants |
| Treatment A | Number of Participants Who Survive With a Functioning Graft | At 12 Months | 25 Participants |
| Treatment A | Number of Participants Who Survive With a Functioning Graft | At 24 Months | 25 Participants |
| Treatment B | Number of Participants Who Survive With a Functioning Graft | At 6 Months | 31 Participants |
| Treatment B | Number of Participants Who Survive With a Functioning Graft | At 12 Months | 31 Participants |
| Treatment B | Number of Participants Who Survive With a Functioning Graft | At 24 Months | 31 Participants |
Secondary
Percentage of Participants With Adverse Events (AEs)
Percentage of participants with AEs up to 24 months post-transplant
Time frame: Up to 24 months Post-Transplant
Population: As Treated Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A | Percentage of Participants With Adverse Events (AEs) | 100.0 Percentage of participants with AEs |
| Treatment B | Percentage of Participants With Adverse Events (AEs) | 97.0 Percentage of participants with AEs |
Secondary
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
Treatment differences in the severity grades to treat all episodes of CSBPAR at 6, 12, and 24 months post-transplant. Type 1A - Cases with significant interstitial infiltration (\>25% of parenchyma affected) and foci of moderate tubulitis (\>4 mononuclear cells/Tubular cross section or group of 10 Tubular cell). Type 1B - Cases with significant interstitial infiltration (\>25% of parenchyma affected) and foci of moderate tubulitis (\>10 mononuclear cells/Tubular cross section or group of 10 Tubular cell).Type 2A - Cases with mild to moderate intimal arteritis.Type 2B - Cases with severe intimal arteritis comprising \>25% of the luminal area. Type 3 - Cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (v3 with accompanying lymphocytic inflammation)
Time frame: At 6, 12 and 24 Months
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 6 Months: Severe Acute | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 12 Months: Moderate Acute (2B) | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 6 Months: Mild Acute (1B) | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 12 Months: Severe Acute | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 12 Months: Mild Acute (1A) | 7.7 Percentage of Participants |
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 24 Months: Mild Acute (1A) | 11.5 Percentage of Participants |
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 6 Months: Moderate Acute (2B) | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 24 Months: Mild Acute (1B) | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 12 Months: Mild Acute (1B) | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 24 Months: Moderate Acute (2A) | 7.7 Percentage of Participants |
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 6 Months: Moderate Acute (2A) | 7.7 Percentage of Participants |
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 24 Months: Moderate Acute (2B) | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 12 Months: Moderate Acute (2A) | 7.7 Percentage of Participants |
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 24 Months: Severe Acute | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 6 Months: Mild Acute (1A) | 3.8 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 24 Months: Severe Acute | 0 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 6 Months: Mild Acute (1A) | 0 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 6 Months: Mild Acute (1B) | 3.1 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 6 Months: Moderate Acute (2A) | 6.3 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 6 Months: Moderate Acute (2B) | 0 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 6 Months: Severe Acute | 0 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 12 Months: Mild Acute (1A) | 3.1 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 12 Months: Mild Acute (1B) | 3.1 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 12 Months: Moderate Acute (2A) | 6.3 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 12 Months: Moderate Acute (2B) | 0 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 12 Months: Severe Acute | 0 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 24 Months: Mild Acute (1A) | 3.1 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 24 Months: Mild Acute (1B) | 3.1 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 24 Months: Moderate Acute (2A) | 6.3 Percentage of Participants |
| Treatment B | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | 24 Months: Moderate Acute (2B) | 0 Percentage of Participants |
Secondary
Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
Characterization of any de novo DSA detected by IgM and IgG subclasses, and by the presence or absence of complement fixing properties.
Time frame: Up to 24 Months
Population: As Treated Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | Baseline Class 2 DSA | 0 Percentage |
| Treatment A | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | De Novo 12 Month Both Class 1 and 2 DSA | 0 Percentage |
| Treatment A | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | De Novo 12 Month Class 1 DSA | 0 Percentage |
| Treatment A | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | De Novo 24 Month Class 1 DSA | 0 Percentage |
| Treatment A | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | Baseline Both Class 1 and 2 DSA | 0 Percentage |
| Treatment A | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | De Novo 24 Month Class 2 DSA | 0 Percentage |
| Treatment A | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | De Novo 12 Month Class 2 DSA | 0 Percentage |
| Treatment A | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | De Novo 24 Month Both Class 1 and 2 DSA | 0 Percentage |
| Treatment A | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | Baseline Class 1 DSA | 10 Percentage |
| Treatment B | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | De Novo 24 Month Both Class 1 and 2 DSA | 0 Percentage |
| Treatment B | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | Baseline Class 1 DSA | 0 Percentage |
| Treatment B | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | Baseline Class 2 DSA | 0 Percentage |
| Treatment B | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | Baseline Both Class 1 and 2 DSA | 0 Percentage |
| Treatment B | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | De Novo 12 Month Class 1 DSA | 0 Percentage |
| Treatment B | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | De Novo 12 Month Class 2 DSA | 0 Percentage |
| Treatment B | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | De Novo 12 Month Both Class 1 and 2 DSA | 0 Percentage |
| Treatment B | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | De Novo 24 Month Class 1 DSA | 3.45 Percentage |
| Treatment B | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | De Novo 24 Month Class 2 DSA | 0 Percentage |
Secondary
Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
Percentage of participants with, and titers of pre-existing (pre-transplant) DSA on Day 1 (pre-transplant, pre-dose), and at Months 12 and 24 posttransplant
Time frame: Up to 24 Months
Population: As Treated Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | Baseline Class 2 DSA | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | 12 Month Both Class 1 and 2 DSA | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | 12 Month Class 1 DSA | 8.00 Percentage of Participants |
| Treatment A | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | 24 Month Class 1 DSA | 8.00 Percentage of Participants |
| Treatment A | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | Baseline Both Class 1 and 2 DSA | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | 24 Month Class 2 DSA | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | 12 Month Class 2 DSA | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | 24 Month Both Class 1 and 2 DSA | 0 Percentage of Participants |
| Treatment A | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | Baseline Class 1 DSA | 10 Percentage of Participants |
| Treatment B | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | 24 Month Both Class 1 and 2 DSA | 0 Percentage of Participants |
| Treatment B | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | Baseline Class 1 DSA | 0 Percentage of Participants |
| Treatment B | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | Baseline Class 2 DSA | 0 Percentage of Participants |
| Treatment B | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | Baseline Both Class 1 and 2 DSA | 0 Percentage of Participants |
| Treatment B | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | 12 Month Class 1 DSA | 0 Percentage of Participants |
| Treatment B | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | 12 Month Class 2 DSA | 3.03 Percentage of Participants |
| Treatment B | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | 12 Month Both Class 1 and 2 DSA | 0 Percentage of Participants |
| Treatment B | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | 24 Month Class 1 DSA | 3.03 Percentage of Participants |
| Treatment B | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | 24 Month Class 2 DSA | 3.03 Percentage of Participants |
Secondary
Percentage of Participants With Events of Special Interest (ESIs)
Percentage of participants which have one of the following events of special interest: Serious Infections Post-Transplant Lymphoproliferative Disorder (PTLD) Progressive multifocal leukoencephalopathy (PML) Malignancies (Other than PTLD) including non-melanoma skin carcinomas (Malignancies) Tuberculosis Infections Central Nervous System (CNS) Infections Viral Infections Infusion Related reactions within 24 hours since belatacept infusion
Time frame: Up to 24 Months
Population: As Treated Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants With Events of Special Interest (ESIs) | Serious Infections | 16 Percentage of participants with ESIs |
| Treatment A | Percentage of Participants With Events of Special Interest (ESIs) | PTLD | 4.0 Percentage of participants with ESIs |
| Treatment A | Percentage of Participants With Events of Special Interest (ESIs) | PML | 0 Percentage of participants with ESIs |
| Treatment A | Percentage of Participants With Events of Special Interest (ESIs) | Malignancies | 4.0 Percentage of participants with ESIs |
| Treatment A | Percentage of Participants With Events of Special Interest (ESIs) | TB | 0 Percentage of participants with ESIs |
| Treatment A | Percentage of Participants With Events of Special Interest (ESIs) | CNS Infections | 0 Percentage of participants with ESIs |
| Treatment A | Percentage of Participants With Events of Special Interest (ESIs) | Viral Infections | 0 Percentage of participants with ESIs |
| Treatment A | Percentage of Participants With Events of Special Interest (ESIs) | Infusion Related Reactions | 1 Percentage of participants with ESIs |
| Treatment B | Percentage of Participants With Events of Special Interest (ESIs) | Infusion Related Reactions | 0 Percentage of participants with ESIs |
| Treatment B | Percentage of Participants With Events of Special Interest (ESIs) | Serious Infections | 15.2 Percentage of participants with ESIs |
| Treatment B | Percentage of Participants With Events of Special Interest (ESIs) | TB | 0 Percentage of participants with ESIs |
| Treatment B | Percentage of Participants With Events of Special Interest (ESIs) | PTLD | 3.0 Percentage of participants with ESIs |
| Treatment B | Percentage of Participants With Events of Special Interest (ESIs) | Viral Infections | 0 Percentage of participants with ESIs |
| Treatment B | Percentage of Participants With Events of Special Interest (ESIs) | PML | 0 Percentage of participants with ESIs |
| Treatment B | Percentage of Participants With Events of Special Interest (ESIs) | CNS Infections | 0 Percentage of participants with ESIs |
| Treatment B | Percentage of Participants With Events of Special Interest (ESIs) | Malignancies | 3.0 Percentage of participants with ESIs |
Secondary
Percentage of Participants With New Onset Diabetes After Transplant
Percentage of participants with New Onset Diabetes After Transplantation (NODAT) at 6, 12, and 24 months post-transplant.
Time frame: up to 24 months
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants With New Onset Diabetes After Transplant | Up to 6 Months | 11.5 Percentage of participants |
| Treatment A | Percentage of Participants With New Onset Diabetes After Transplant | Up to 12 Months | 11.5 Percentage of participants |
| Treatment A | Percentage of Participants With New Onset Diabetes After Transplant | Up to 24 Months | 15.4 Percentage of participants |
| Treatment B | Percentage of Participants With New Onset Diabetes After Transplant | Up to 6 Months | 6.3 Percentage of participants |
| Treatment B | Percentage of Participants With New Onset Diabetes After Transplant | Up to 12 Months | 6.3 Percentage of participants |
| Treatment B | Percentage of Participants With New Onset Diabetes After Transplant | Up to 24 Months | 12.5 Percentage of participants |
Secondary
Percentage of Participants With Serious Adverse Events (SAEs)
Percentage of participants with SAEs up to 24 months post-transplant
Time frame: Up to 24 months Post-Transplant
Population: As Treated Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A | Percentage of Participants With Serious Adverse Events (SAEs) | 52.0 Percentage of participants with SAEs |
| Treatment B | Percentage of Participants With Serious Adverse Events (SAEs) | 60.6 Percentage of participants with SAEs |
Secondary
Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Percentage of participants with laboratory tests with marked laboratory abnormalities
Time frame: At 24 Months
Population: As Treated Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Lymphocyte (Absolute) (low) | 84.0 Percentage of participants |
| Treatment A | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Potassium (high) | 4.0 Percentage of participants |
| Treatment A | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Aspartate Aminotransferase (High) | 4.0 Percentage of participants |
| Treatment A | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Sodium (low) | 4.0 Percentage of participants |
| Treatment A | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Leukocytes (low) | 0 Percentage of participants |
| Treatment A | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Albumin (low) | 0 Percentage of participants |
| Treatment A | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Creatinine (High) | 16.0 Percentage of participants |
| Treatment A | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Glucose (high) | 8.0 Percentage of participants |
| Treatment A | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Neutrophils (Absolute) (low) | 0 Percentage of participants |
| Treatment A | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Triglycerides (high) | 12.0 Percentage of participants |
| Treatment A | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Inorganic Phosphorus (low) | 24.0 Percentage of participants |
| Treatment A | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Uric Acid (high) | 8.0 Percentage of participants |
| Treatment A | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Hemoglobin (Low) | 12.0 Percentage of participants |
| Treatment B | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Uric Acid (high) | 0 Percentage of participants |
| Treatment B | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Hemoglobin (Low) | 6.1 Percentage of participants |
| Treatment B | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Leukocytes (low) | 3.0 Percentage of participants |
| Treatment B | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Lymphocyte (Absolute) (low) | 69.7 Percentage of participants |
| Treatment B | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Neutrophils (Absolute) (low) | 3.0 Percentage of participants |
| Treatment B | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Aspartate Aminotransferase (High) | 0 Percentage of participants |
| Treatment B | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Creatinine (High) | 3.0 Percentage of participants |
| Treatment B | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Inorganic Phosphorus (low) | 12.1 Percentage of participants |
| Treatment B | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Potassium (high) | 0 Percentage of participants |
| Treatment B | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Sodium (low) | 0 Percentage of participants |
| Treatment B | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Albumin (low) | 3.0 Percentage of participants |
| Treatment B | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Glucose (high) | 12.1 Percentage of participants |
| Treatment B | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Triglycerides (high) | 0 Percentage of participants |
Secondary
Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR).
Time to Clinically suspected biopsy proven acute rejection
Time frame: Up to 24 Months
Population: Participants with a CSBPAR
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment A | Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR). | NA Months |
| Treatment B | Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR). | NA Months |
Secondary
Time to Event: Graft Loss and Death
The Number of days to participant Graft Loss and death for any reason
Time frame: Up to 728 Days
Population: All Treated Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Time to Event: Graft Loss and Death | Graft Loss | 107 Days |
| Treatment B | Time to Event: Graft Loss and Death | Graft Loss | 2 Days |
Secondary
Treatment Differences in Therapeutic Modalities
Treatment Received for Biopsy Proven Acute Rejection (Banff Grade IA or Higher), or Humoral (Antibody Mediated) Rejection Treatment regimen: Categorical analysis of CSBPAR episodes by treatment received.
Time frame: at 6, 12 and 24 Months
Population: All Randomized, Transplanted and Treated Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Treatment Differences in Therapeutic Modalities | Plasmapheresis (6 months) | 0 Percentage of participants with CSBPARs |
| Treatment A | Treatment Differences in Therapeutic Modalities | Plasmapheresis (12 months) | 0 Percentage of participants with CSBPARs |
| Treatment A | Treatment Differences in Therapeutic Modalities | Rituximab (6 months) | 0 Percentage of participants with CSBPARs |
| Treatment A | Treatment Differences in Therapeutic Modalities | IVIG (12 months) | 0 Percentage of participants with CSBPARs |
| Treatment A | Treatment Differences in Therapeutic Modalities | IVIG (6 months) | 0 Percentage of participants with CSBPARs |
| Treatment A | Treatment Differences in Therapeutic Modalities | Rituximab (12 months) | 0 Percentage of participants with CSBPARs |
| Treatment A | Treatment Differences in Therapeutic Modalities | Lymphocyte depleting agent (6 months) | 0 Percentage of participants with CSBPARs |
| Treatment A | Treatment Differences in Therapeutic Modalities | Corticosteroids (24 months) | 19.2 Percentage of participants with CSBPARs |
| Treatment A | Treatment Differences in Therapeutic Modalities | Corticosteroids (12 months) | 15.4 Percentage of participants with CSBPARs |
| Treatment A | Treatment Differences in Therapeutic Modalities | Plasmapheresis (24 months) | 0 Percentage of participants with CSBPARs |
| Treatment A | Treatment Differences in Therapeutic Modalities | Corticosteroids (6 months) | 7.7 Percentage of participants with CSBPARs |
| Treatment A | Treatment Differences in Therapeutic Modalities | IVIG (24 months) | 0 Percentage of participants with CSBPARs |
| Treatment A | Treatment Differences in Therapeutic Modalities | Lymphocyte depleting agent (12 months) | 3.8 Percentage of participants with CSBPARs |
| Treatment A | Treatment Differences in Therapeutic Modalities | Rituximab (24 months) | 0 Percentage of participants with CSBPARs |
| Treatment A | Treatment Differences in Therapeutic Modalities | Lymphocyte depleting agent (24 months) | 3.8 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | Rituximab (24 months) | 0 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | Lymphocyte depleting agent (24 months) | 6.3 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | Rituximab (6 months) | 0 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | Corticosteroids (6 months) | 9.4 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | Lymphocyte depleting agent (6 months) | 6.3 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | Plasmapheresis (6 months) | 0 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | IVIG (6 months) | 3.1 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | Corticosteroids (12 months) | 12.5 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | Lymphocyte depleting agent (12 months) | 6.3 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | Plasmapheresis (12 months) | 0 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | IVIG (12 months) | 3.1 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | Rituximab (12 months) | 0 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | Corticosteroids (24 months) | 12.5 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | Plasmapheresis (24 months) | 0 Percentage of participants with CSBPARs |
| Treatment B | Treatment Differences in Therapeutic Modalities | IVIG (24 months) | 3.1 Percentage of participants with CSBPARs |
Secondary
Urine Protein Creatinine Ratio (UPr/Cr)
Urine protein to creatinine ratio (UPr/Cr) at 3, 6, 12 and 24 months post-transplant.
Time frame: Up 24 Months post-transplant
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment A | Urine Protein Creatinine Ratio (UPr/Cr) | At 3 Months | 0.3146 mg Protein/mg Creatinine |
| Treatment A | Urine Protein Creatinine Ratio (UPr/Cr) | At 6 Months | 0.3896 mg Protein/mg Creatinine |
| Treatment A | Urine Protein Creatinine Ratio (UPr/Cr) | At 12 Months | 0.2835 mg Protein/mg Creatinine |
| Treatment A | Urine Protein Creatinine Ratio (UPr/Cr) | At 24 Months | 0.3940 mg Protein/mg Creatinine |
| Treatment B | Urine Protein Creatinine Ratio (UPr/Cr) | At 24 Months | 0.1685 mg Protein/mg Creatinine |
| Treatment B | Urine Protein Creatinine Ratio (UPr/Cr) | At 3 Months | 0.1412 mg Protein/mg Creatinine |
| Treatment B | Urine Protein Creatinine Ratio (UPr/Cr) | At 12 Months | 0.1849 mg Protein/mg Creatinine |
| Treatment B | Urine Protein Creatinine Ratio (UPr/Cr) | At 6 Months | 0.1461 mg Protein/mg Creatinine |