drugset
drugset / Trial / NCT02686619

Study Comparing Efficacy and Safety of Mycophenolate Mofetil (Cellcept) With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Mycophenolate Mofetil and Long Term Continuation of Cyclosporine in Renal Transplant Recipients

NCT02686619 ↗

Phase 3 Completed 237 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This multicentre, prospective, randomized, open-label study will compare the safety and efficacy of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation of cyclosporine, with those of mycophenolate mofetil and long term continuation of cyclosporine in renal transplant recipients receiving daclizumab (Zenapax) as induction treatment and followed by 8 month treatment with corticosteroids. The anticipated time on study treatment is 12 months. Participants who will complete the initial 12-month study and who will provide written informed consent will be eligible to participate in a 60-month follow-up phase.

Timeline

Start
2004-11
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide — Oral
Subject Sirolimus Small molecule 6 mg Oral
Background Daclizumab Monoclonal antibody 1 mg/kg Intravenous
Background Mycophenolate Mofetil Small molecule 1 g Oral
Background Prednisolone Other / unclassified 10 mg Intravenous

Indications

No indication recorded.