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临床试验/NCT00273871
NCT00273871已完成3 期

A Multi-centre, Randomized, Open-label, Study to Compare Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients on Maintenance Therapy With Mild to Moderate Renal Insufficiency.

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 190 人开始时间: 2002年1月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
190
主要终点
Difference between treatment groups in renal function at 12 months.

研究概览

简要总结

The purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to Rapamune based therapy in patients with mild to moderate renal insufficiency.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 18
  • Treatment with a calcineurin inhibitor
  • Patients with mild to moderate renal insufficiency

排除标准

  • Patients with acute rejection
  • Patients who received a transplant more than 10 years ago

结局指标

主要结局

Difference between treatment groups in renal function at 12 months.

次要结局

  • Incidence of acute rejection, patient and graft survival at 12 months, labs and physical examinations, quality of life etc.

研究者

发起方
Wyeth is now a wholly owned subsidiary of Pfizer
申办方类型
Industry

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