drugset / Trial / NCT00195273
Study Evaluating Sirolimus in Kidney Transplant Recipients
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.
Timeline
- Start
- 2004-11
- Primary completion
- 2008-07
- Completion
- 2008-07
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Sirolimus vs Cyclosporine (CsA); p = 0.6081; ANOVA; note: Calculated for 12 month analysis NCT00195273 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclosporine | Peptide | 10 mg/kg | — |
| Subject | Daclizumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Sirolimus | Small molecule | 5 mg | — |
| Background | Mycophenolate Mofetil | Small molecule | 1 g | — |
| Background | Prednisolone | Other / unclassified | 5 mg | — |
| Background | Prednisolone | Other / unclassified | 7.5 mg | — |