临床试验/NCT00241059

NCT00241059已完成4 期

A Prospective, Open-label, Multicenter, International Follow-up Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

Novartis0 个研究点目标入组 183 人开始时间: 2002年8月最近更新: 2011年1月31日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Novartis
入组人数: 183
主要终点: Safety parameters and graft function in maintenance renal transplant recipients.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•All patients who completed study CERL080A2405-LA01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

排除标准

•Other protocol-defined inclusion / exclusion criteria may apply

研究组 & 干预措施

EC-MPS arm

Experimental

干预措施: Enteric-Coated Mycophenolate Sodium (EC-MPS) (Drug)

结局指标

主要结局

Safety parameters and graft function in maintenance renal transplant recipients.

次要结局

Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.

研究者

发起方

Novartis

申办方类型

Industry

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