NCT00223015已完成4 期
Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation
University Hospital Schleswig-Holstein0 个研究点目标入组 15 人开始时间: 2004年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
Steady state pharmacokinetics of tacrolimus, mycophenolat mofetil and fluvastatin in renal transplant patients are investigated to look for potential interaction between these drugs.
All patient enrolled in this PKI-Study had no changes in the therapy before or because of the study. Only patients without changes more than 4 weeks were included
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •renal transplant patients (18 - 65 years, inclusive)
- •cadaver and living renal transplants(
- •Immunsuppression: Tacrolimus with or without Mycophenolat Mofetil und and fluvastatin Fluvastatin for a minimum of three months
- •writen informt consent by the patient
排除标准
- •contraindications for statins
- •pregnancy or lactating
- •elevated liver or muscle encymes (> 2x up to normal values: AST, ALT, bilirubine, CPK)
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