drugset / Trial / NCT02152345
Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients
RandomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to find out whether treatment to prevent kidney rejection with belatacept in presence of Thymoglobulin induction and withdrawal of steroids will result in less delayed graft function or "sleepy kidney" after transplant than that seen in patients who get tacrolimus as their main drug to prevent rejection instead of belatacept. The investigators will also look at whether patients who get belatacept have the same, lesser or more problems that those who get tacrolimus.
Timeline
- Start
- 2014-06
- Primary completion
- 2016-12-31
- Completion
- 2016-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belatacept | Protein / enzyme biologic | 5 mg/kg | — |
| Comparator | Tacrolimus | Small molecule | 0.05 mg/kg | Oral |
| Background | Methylprednisolone | Other / unclassified | 75 mg | Intravenous |
| Background | Mycophenolate Sodium | Unknown | 720 mg | Oral |
| Background | rATG | Unknown | 1.5 mg/kg | Intravenous |