NCT00865449已完成3 期
Role of Renin Angiotensin Blockade in Peritoneal Fibrosis in Peritoneal Dialysis Patients
Instituto Nacional de Cardiologia Ignacio Chavez1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peritoneal fibrosis
研究概览
简要总结
This is a double blind randomized controlled study to evaluate the effect of aldactone on peritoneal fibrosis on incident peritoneal dialysis patients. The study would include a total of 40 incident peritoneal dialysis patients. Peritoneal biopsy would be made at randomization and 6 months after the intervention to evaluate the effect of renin angiotensin blockade on peritoneal fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age > 18
- •Hospitalized for peritoneal catheter placement for peritoneal dialysis
排除标准
- •Pregnancy
- •Hiperkalemia (K> 5.5meq/l)
- •Intolerance to spironolactone
研究组 & 干预措施
2
Placebo Comparator
Peritoneal dialysis Patients on the placebo arm for 6 months
干预措施: Placebo (Drug)
1
Active Comparator
Peritoneal Dialysis patients on aldactone for 6 months
干预措施: spironolactone (Drug)
结局指标
主要结局
Peritoneal fibrosis
时间窗: 6 months
次要结局
未报告次要终点
研究者
Magdalena Madero
MD
Instituto Nacional de Cardiologia Ignacio Chavez
研究点 (1)
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