NCT00223028已完成4 期
Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation
University Hospital Schleswig-Holstein0 个研究点目标入组 15 人开始时间: 2005年4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
To investigate in renal transplant recipients the potential drug intreaction between Sirolimus, Mycophenolt Mofetil and Fluvastatin
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 before startin the study 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
- Treatment
- 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: sirolimus 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)
研究者
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