NCT01891292Unknown不适用
A Phase 2 Study of the Efficacy of Antioxidant Therapy Compared With Enalapril in Slowing the Progression of Sickle Nephropathy in Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- urinary albumin excretion rate
研究概览
简要总结
The purpose of this study is to determine whether enalapril or antioxidant therapy (N-Acetylcysteine) is effective in reducing microalbuminuria in children with sickle cell disease and and its progression to sickle nephropathy
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
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Homozygous S sickle cell disease
- •Diagnosed by newborn screening
- •determined to have persistent microalbuminuria
- •satisfied criteria for microalbuminuria screening
- •parental consent
排除标准
- •Asymptomatic bacteriuria on screening urine cultures
- •On Hydroxyurea therapy
- •Pre-existing complications of SCD which would meet local criteria for HU therapy
研究组 & 干预措施
Enalapril
Active Comparator
干预措施: Enalapril (Drug)
N-Acetylcysteine
Active Comparator
干预措施: N-Acetylcysteine (Drug)
结局指标
主要结局
urinary albumin excretion rate
时间窗: 12 months
次要结局
- Glomerular filtration rate(12 months)
研究者
Marvin Reid
Professor
The University of The West Indies
研究点 (1)
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