drugset / Trial / NCT00596947
Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study was to determine if rapid discontinuation of corticosteroids (also known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus) and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin) will give similar safety and efficacy results compared to continuation of corticosteroids (also known as prednisone maintenance) and standard maintenance immunosuppression with Prograf (tacrolimus), CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin).
Timeline
- Start
- 2005-10
- Primary completion
- 2009-03
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mycophenolate Mofetil | Small molecule | 500 mg | Oral |
| Comparator | Mycophenolate Mofetil | Small molecule | 1000 mg | Oral |
| Subject | Prednisone | Other / unclassified | 5 mg | Oral |
| Background | Tacrolimus | Small molecule | 0.1 mg/kg | Oral |
| Background | Tacrolimus | Small molecule | 0.2 mg/kg | Oral |
| Background | Thymoglobulin | Protein / enzyme biologic | 1.5 mg/kg | Intravenous |
Indications
No indication recorded.