drugset / Trial / NCT00455013
A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this clinical research study is to learn if belatacept (BMS-224818) is expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based immunosuppressive regiments compared to a similar steroid-free tacrolimus regimen. The long-term safety and tolerability of belatacept based regimens following long-term administration in subjects who have received a kidney transplant
Timeline
- Start
- 2007-07
- Primary completion
- 2008-10
- Completion
- 2012-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belatacept | Protein / enzyme biologic | 5 mg/kg | Intravenous |
| Subject | Sirolimus | Small molecule | 5 mg | — |
| Subject | Tacrolimus | Small molecule | 0.1 mg/kg | Oral |
| Background | Mycophenolate Mofetil | Small molecule | 1 g | Oral |
| Background | Mycophenolate Mofetil | Small molecule | 1.5 g | Oral |
| Background | Thymoglobulin | Protein / enzyme biologic | 1.5 mg/kg | Intravenous |