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 69 人开始时间: 2003年4月1日最近更新: 2011年1月31日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 69
主要终点: To assess patient and graft survival, acute rejection incidence, graft function and specific pertinent safety parameters in de novo renal transplant recipients.

研究概览研究设计入排标准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

This extension study is 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 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Inclusion /

排除标准

•All patients who completed study CERL080A2405-IN01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.
•Other protocol-defined inclusion / exclusion criteria may apply

结局指标

主要结局

To assess patient and graft survival, acute rejection incidence, graft function and specific pertinent safety parameters in de novo renal transplant recipients.

次要结局

To assess the respective influence of parameters (demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications) on clinical outcomes.

研究者

发起方

Novartis

申办方类型

Industry

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