NCT00035555

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Graft Rejection
• Kidney Transplantation
• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Belatacept	Solution, intravenous
DRUG	Cyclosporine	Oral, capsule
DRUG	Mycophenolate mofetil (MMF)	Oral, capsule
DRUG	Corticosteroids	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

Timeline

• Start date: 2001-03-01
• Primary completion: 2004-01-01
• Completion: 2012-07-01
• First posted: 2002-05-06
• Last updated: 2014-01-13
• Results posted: 2014-01-13

Locations

12 sites across 1 country: United States