NCT01021943暂停2 期
The Role of Spironolactone in Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients
Instituto Nacional de Cardiologia Ignacio Chavez1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention)
研究概览
简要总结
The main objective of this study is to assess the effect of spironolactone on interstitial fibrosis in kidney transplant recipients receiving calcineurin inhibitors
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney Failure
- •Age > 18
- •Kidney transplant recipients
排除标准
- •Patients taking angiotensin receptor blockers or inhibitors of the angiotensin reconverting enzyme
- •Kidney transplant performed more than one month from enrollment in the study
- •Hyperkalemia (K> 5.5 meqL)
研究组 & 干预措施
Placebo
Placebo Comparator
Half of the subjects will be assigned to receive either spironolactone or placebo for 6 months
干预措施: Placebo (Drug)
spironolactone
Active Comparator
Half of the subjects will be randomized to receive spironolactone for 6 months
干预措施: spironolactone (Drug)
结局指标
主要结局
Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention)
时间窗: 2 years
次要结局
- allograft function and proteinuria(2 years)
- Fibrosis markers in kidney biopsies such as TGF-B(2 years)
研究者
Magdalena Madero
Chief Nephrology Division
Instituto Nacional de Cardiologia Ignacio Chavez
研究点 (1)
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