Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney

Phase II/III, Open-Label, Randomized, Controlled, Multiple-Dose Study of Efficacy and Safety of BMS-224818 (Belatacept) as Part of a Quadruple Drug Regimen in First Renal Transplant Recipients

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).

Key inclusion criteria

• Recipients of first kidney transplant

Key exclusion criteria

• Those at high risk for acute allograft rejection, including those who receive a second or more renal transplant, those with a history of panel reactive antibody levels >20%, and those considered by investigators to be at relatively higher risk for acute rejection
• Human leukocyte antigen-identical donor-recipient pairs
• Cold ischemia time >36 hours (donor kidney)
• Participants who are positive for hepatitis C antibody, on polymerase chain reaction, for hepatitis B surface antigen, and for human immunodeficiency virus
• A positive purified protein derivative tuberculosis test (test performed within 1 year of enrollment), unless previously vaccinated with Bacille-Calmette-Guérin or those who had a history of adequate chemoprophylaxis
• Any active infection that would normally exclude transplantation
• Recipients of multiple organ transplants
• Donor age >60 or <6 years or donors whose hearts were not beating
• Recipients with underlying renal disease of (due to risk of rapid disease recurrence in the allograft): focal segmental glomerulosclerosis, Type I or II membranoproliferative glomerulonephritis, or hemolytic uremic syndrome/ thrombotic thrombocytopenic purpura
• A positive T-cell lymphocytoxic crossmatch using donor lymphocytes and recipient serum
• A history of true allergy to intravenous iodinated roentgenographic contrast agents
• Participants with life expectancy severely limited by disease state or other underlying medical condition
• A history of cancer (other than nonmelanoma skin cell cancers cured by local resection) within the last 5 years
• Mammogram film with any clinically significant abnormality requiring further investigation or biopsies
• History of substance abuse (drug or alcohol) or psychotic disorders that were not compatible with adequate study follow-up
• A currently functioning, nonrenal transplant
• Previous treatment with basiliximab for any reason
• Active peptic ulcer disease, chronic diarrhea, or gastrointestinal malabsorption
• Those who had used any investigational drug within 30 days before the Day 1 visit.