A 6-month, 1-arm, Open-label Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)

Novartis Pharmaceuticals0 个研究点目标入组 50 人开始时间: 2003年1月最近更新: 2011年11月2日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novartis Pharmaceuticals
入组人数: 50
主要终点: Tolerability based on adverse events within 6 months after switch from MMF to an optimized enteric-coated mycophenolate sodium 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

The aim of this study is whether a switch of stable renal transplant recipients who receive tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients.

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

未提供

排除标准

未提供

结局指标

主要结局

Tolerability based on adverse events within 6 months after switch from MMF to an optimized enteric-coated mycophenolate sodium regimen.

次要结局

Safety based on renal function within 6 months after medication switch.
Pharmacokinetics of enteric-coated mycophenolate sodium in combination with tacrolimus in a subpopulation at baseline, week 2, month 3
Influence of enteric-coated mycophenolate sodium on the activity of an enzyme at baseline, week 2, month 3
Incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.
Graft survival and patient survival 6 months post medication switch.

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

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