跳至主要内容
临床试验/NCT00275639
NCT00275639已完成4 期

A Randomized, Double-blinded, Placebo-controlled Study of Angiotensin II Receptor Blockade to Prevent Renal Dysfunction Following Liver Transplantation.

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2004年12月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Mayo Clinic
入组人数
62
试验地点
2
主要终点
Development of renal dysfunction (measured by iothalamate clearance).

研究概览

简要总结

This research study is being done to study the effects, both good and bad, of calcineurin inhibitors and the drug Cozaar (losartan), on kidney function and kidney scarring following a liver transplant.

详细描述

This study is a double-blinded, placebo controlled trial to help determine the pathogenesis of chronic renal dysfunction in patients undergoing liver transplantation. It will examine the renal function and renal morphology in patients on calcineurin inhibitors and the effects of Cozaar (losartan) following liver transplantation. Participants will have blood, urine and iothalamate clearance test, to look at kidney function prior to transplant. At the time of transplant, kidney biopsies will be performed in the operating room under anesthesia. Participants will be in the study for one year. At three weeks following liver transplant, participants will be randomly assigned to receive either a placebo (inactive drug) or the study drug (losartan). The participant will need to continue to return to the clinic at the normal scheduled intervals. During these times blood and urine tests will be done. A kidney biopsy will be performed at the yearly exam and study pills will be stopped. The researchers will continue to follow participant's creatine measurements for the next 10 years.

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
Double

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Development of renal dysfunction (measured by iothalamate clearance).

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other

研究点 (2)

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