A One Arm, Open-label Study to Investigate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Recipients Who Received Mycophenolate Mofetil (MMF)

Novartis0 个研究点目标入组 187 人开始时间: 2002年11月1日最近更新: 2011年1月31日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novartis
入组人数: 187
主要终点: Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium.

This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

•- Only patients who were participating in study CERL080A2405-DE02 and have completed the first 6 months of the core study can be included in this additional extension study.
•Other protocol-defined inclusion/exclusion criteria may apply.

Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium.

Safety based on renal function within 6 months after medication switch.
Pharmacokinetics (PK) in a randomized subpopulation.
Efficacy measured by the incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.
Efficacy measured by the incidence of biopsy-proven acute rejection 6 months post medication switch.
Graft survival and patient survival 6 months post medication switch.

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