The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is as efficacious as treatment with cyclosporine at preventing acute rejection and with a superior safety/tolerability profile (better kidney function and blood pressure, fewer lipid problems, less diabetes mellitus).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
230
Univ. of Calif. - San Francisco
San Francisco, California, United States
Emory Univ. School of Medicine
Atlanta, Georgia, United States
Johns Hopkins University
Baltimore, Maryland, United States
Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR)
No participant was to receive treatment for acute rejection without a biopsy to confirm the diagnosis. CSPAR=Clinically-suspected rejection, defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function, and biopsy-proven rejection, which includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed.
Time frame: By Month 6 posttransplant (From Day 1 to Month 6)
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12
BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed.
Time frame: Through Months 6 and 12 posttransplant (From Day 1 to Months 6 and 12)
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection
BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed. A participant was reported as having had an episode of treated acute rejection if he or she received antirejection therapy during an episode of rejection (clinically-suspected or biopsy-proven rejection).
Time frame: By Months 3, 6, and 12 posttransplant (Day 1 to Months 3, 6, and 12)
Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR)
Throughout this study, acute rejection=clinically-suspected and biopsy-proven acute rejection (BPAR). Clinically-suspected rejection is defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function. BPAR includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed. PAR is defined as an elevation in SCr ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function that led the investigator to suspect that the participant had experienced acute rejection, and in whom either the biopsy did not confirm acute rejection and the participant received treatment for acute rejection or the participant received treatment for acute rejection without a biopsy to confirm the diagnosis.
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Corticosteroids given daily, orally or intravenously (IV). Day of transplant (Day 1): methylprednisolone, 500 mg, given IV on arrival in operating room; Day 2: methylprednisolone, 250 mg, given IV once daily; Day 3: prednisone, 100 mg, given orally once daily; Day 4: prednisone, 50 mg, given orally once daily; Days 5 through 30: prednisone, 25 mg, given orally once daily; Days 31-44: prednisone, 22.5 mg, given orally once daily; Days 45-58: prednisone, 20 mg, given orally once daily
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Univ. of Nebraska Medical Center
Omaha, Nebraska, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Mount Sinai Medical Center
New York, New York, United States
Univ. of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical Univ. of South Carolina
Charleston, South Carolina, United States
...and 2 more locations
Time frame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Percentage of Participants Who Had Chronic Allograft Nephropathy
Based on postbaseline biopsies
Time frame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Mean Iohexol Clearance
Iohexol, a true glomerular filtration marker, is used to measure glomerular filtration rate.
Time frame: By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)
Percentage of Participants Who Used Antihypertensive Medication
Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg
Time frame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Number of Participants With Hypertension
Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg or, the use of any antihypertensive medication.
Time frame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels
LDL=low-density lipoprotein; HDL=high-density lipoprotein. Total cholesterol=LDL + HDL + very low-density (VLDL) cholesterol. VLDL=triglycerides divided by 5. Non-HDL cholesterol=Total cholesterol minus HDL cholesterol.
Time frame: By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)
Number of Participants With Posttransplant Diabetes Mellitus
Posttransplant diabetes mellitus is defined as the need for treatment of hyperglycemia with either an oral agent or insulin for a total of \>4 weeks or hemoglobin A1c (HbA1c) \>7% in a participant not known to be diabetic prior to transplantation
Time frame: By Months 1, 3, 6, 9, and 12 posttransplant (Day 1 to Months 1, 3, 6, 9, and 12 )