drugset / Trial / NCT00239031

Study of Enteric-Coated Mycophenolate Sodium (EC-MPS) Plus Reduced-dose Cyclosporine Microemulsion (CsA-ME) Compared to EC-MPS Plus Standard Dose CsA-ME in Eldery de Novo Renal Transplant Recipients Treated With Basiliximab and Short-term Steroids

NCT00239031

Phase 3 Completed 117 enrolled Novartis
RandomizedParallel-groupOpen-labelPrevention

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 aim of this study is to compare the renal function, 6 months after transplant, in de novo old-age renal transplant recipients treated with EC-MPS plus reduced dose CsA-ME or with EC-MPS plus standard dose CsA-ME, both in combination with basiliximab and short-term oral steroids.

Timeline

Start
2002-03
Primary completion
2005-07
Completion
2005-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Sodium Unknown

Indications

No indication recorded.