Availability and Safety Study of ACTH to Treat Children SRNS/SDNS
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- 24-hour proteinuria excretion
研究概览
简要总结
Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary nephrotic syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of the main relapse reasons.Adrenocorticotropic hormone(ACTH)-induced steroidogenesis improve serum cortisol and also direct melanocortin receptors(MCRs) mediated protective effect on kidney cells. To investigate the efficacy and safety of ACTH to treat NS, total 42 children steroid resistant or steroid dependent NS is enrolling in this multicenter, prospective case series of prescription based treatment with ACTH for NS.
详细描述
Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary nephrotic syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of the main relapse reasons.Adrenocorticotropic hormone(ACTH) can stimulates the adrenal cortex and its production of corticosteroids.ACTH also direct melanocortin receptors(MCRs) mediated protective effect on kidney cells. To investigate the efficacy and safety of ACTH to treat NS, total 42 children steroid resistant or steroid dependent NS is enrolling in this multicenter, prospective case series of prescription based treatment with ACTH for NS.
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
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age:3-12 years old
- •primary nephrotic syndrome
- •SRNS or SDNS
- •Minor lesion or minimal change disease
- •Signed informed consent
排除标准
- •Second nephrotic syndrome
- •allergic to ACTH
- •Refuse to signed informed consent
- •have had ACTH treatment
- •serious complication
研究组 & 干预措施
ACTH(+)
routine treatment + ACTH
干预措施: ACTH (Drug)
结局指标
主要结局
24-hour proteinuria excretion
时间窗: 1.5 years
次要结局
- times of relapse(1.5 years)