drugset / Trial / NCT00275535
The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients
Phase 4
Completed
165 enrolled
Mayo Clinic
Genzyme, a Sanofi Company · collabRoche Pharma AG · collabWyeth is now a wholly owned subsidiary of Pfizer · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.
Timeline
- Start
- 2001-04
- Primary completion
- 2007-11
- Completion
- 2008-12
Publications
- Results Dean PG, Grande JP, Sethi S, Park WD, Griffin MD, Cosio FG, Larson TS, Stegall MD. Kidney transplant histology after one year of continuous therapy with sirolimus compared with tacrolimus. Transplantation. 2008 Apr 27;85(8):1212-5. doi: 10.1097/TP.0b013e31816a8ae6.
- Results Larson TS, Dean PG, Stegall MD, Griffin MD, Textor SC, Schwab TR, Gloor JM, Cosio FG, Lund WJ, Kremers WK, Nyberg SL, Ishitani MB, Prieto M, Velosa JA. Complete avoidance of calcineurin inhibitors in renal transplantation: a randomized trial comparing sirolimus and tacrolimus. Am J Transplant. 2006 Mar;6(3):514-22. doi: 10.1111/j.1600-6143.2005.01177.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sirolimus | Small molecule | 3 mg | — |
| Comparator | Sirolimus | Small molecule | 5 mg | — |
| Comparator | Tacrolimus | Small molecule | — | — |
| Comparator | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 1.5 mg/kg | — |
| Comparator | Mycophenolate Mofetil | Small molecule | 750 mg | Oral |
| Comparator | Prednisone | Other / unclassified | 5 mg | — |