drugset / Trial / NCT00035555
Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney
RandomizedParallel-groupOpen-labelPrevention
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).
Timeline
- Start
- 2001-03
- Primary completion
- 2004-01
- Completion
- 2012-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belatacept | Protein / enzyme biologic | 5 mg/kg | Intravenous |
| Subject | Cyclosporine | Peptide | — | Oral |
| Background | Methylprednisolone | Other / unclassified | — | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 2 g | Oral |
| Background | Prednisone | Other / unclassified | 20 mg | Oral |