An Open Label Study to Evaluate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Maintenance Renal Transplant Recipients

Novartis Pharmaceuticals0 个研究点目标入组 40 人开始时间: 2002年12月最近更新: 2011年11月2日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis Pharmaceuticals
入组人数: 40
主要终点: Adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen .

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

To evaluate whether maintenance renal transplant patients on micophenolate mofetil (MMF) can be safely converted to EC-MPS, based on adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen.

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 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

结局指标

主要结局

Adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen .

次要结局

Pharmacokinetic profiles of MMF and EC-MPS.
Patient and graft survival, graft function
Safety

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

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