drugset / Trial / NCT00238992

Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.

NCT00238992

Phase 3 Completed 144 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug. The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.

Timeline

Start
2002-12
Primary completion
2005-07
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Sodium Unknown

Indications

No indication recorded.