drugset / Trial / NCT01601821
Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids
RandomizedParallel-groupOpen-labelTreatment
Summary
To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the introduction of MMF in de novo renal allograft recipients.
Timeline
- Start
- 2006-04
- Primary completion
- 2008-03
- Completion
- 2008-03
Outcome
Missed primary endpoint
registry analysis (superiority or other test); CsA+Rapamune+CS vs CsA+MMF+CS; p = 0.341; percent difference -2.0 (90% CI -5.5 to 1.5); Chi-squared NCT01601821 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclosporine | Peptide | — | — |
| Subject | Mycophenolate Mofetil | Small molecule | — | — |
| Comparator | Sirolimus | Small molecule | 2 mg | — |
Indications
No indication recorded.