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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is as efficacious as treatment with cyclosporine at preventing acute rejection and with a superior safety/tolerability profile (better kidney function and blood pressure, fewer lipid problems, less diabetes mellitus).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept; Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Key inclusion criteria

• Recipients of first kidney transplant

Key exclusion criteria

• Those at high risk for acute allograft rejection, including those who receive a second or more renal transplant, those with a history of panel reactive antibody levels >20%, and those considered by investigators to be at relatively higher risk for acute rejection

• Human leukocyte antigen-identical donor-recipient pairs

• Cold ischemia time >36 hours (donor kidney)

• Participants who are positive for hepatitis C antibody, on polymerase chain reaction, for hepatitis B surface antigen, and for human immunodeficiency virus

• A positive purified protein derivative tuberculosis test (test performed within 1 year of enrollment), unless previously vaccinated with Bacille-Calmette-Guérin or those who had a history of adequate chemoprophylaxis

• Any active infection that would normally exclude transplantation

• Recipients of multiple organ transplants

• Donor age >60 or <6 years or donors whose hearts were not beating

• Recipients with underlying renal disease of (due to risk of rapid disease recurrence in the allograft): focal segmental glomerulosclerosis, Type I or II membranoproliferative glomerulonephritis, or hemolytic uremic syndrome/ thrombotic thrombocytopenic purpura

• A positive T-cell lymphocytoxic crossmatch using donor lymphocytes and recipient serum

• A history of true allergy to intravenous iodinated roentgenographic contrast agents

• Participants with life expectancy severely limited by disease state or other underlying medical condition

• A history of cancer (other than nonmelanoma skin cell cancers cured by local resection) within the last 5 years

• Mammogram film with any clinically significant abnormality requiring further investigation or biopsies

• History of substance abuse (drug or alcohol) or psychotic disorders that were not compatible with adequate study follow-up

• A currently functioning, nonrenal transplant

• Previous treatment with basiliximab for any reason

• Active peptic ulcer disease, chronic diarrhea, or gastrointestinal malabsorption

• Those who had used any investigational drug within 30 days before the Day 1 visit.