Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Remission Rate
研究概览
简要总结
To determine the efficacy of tacrolimus in the management of NS(nephrotic syndrome) , the investigators designed this prospective study. The investigators will enroll 100 children with NS(frequent relapse steroid dependent NS, steroid resistance NS) who will be treated with tacrolimus (0.1-0.2 mg/kg/day in two divided doses over 12 h adjusted to a trough level between 5 and 10 ng/ml) for 12 months in combination with low-dose steroids. Other therapies will be included angiotensin-converting enzyme inhibitors, antihypertensive drugs, multivitamins and lipid-lowering agents.
Follow-up is every second week for the first 4 weeks, then monthly. After initiation of tacrolimus therapy, blood was drawn each visit to determine tacrolimus trough levels.
详细描述
Subsequently , monthly measurements were made until stable levels of tacrolimus were achieved. Urine was analyzed for proteinuria at each visit. Serum creatinine, glucose, albumin and alanine aminotransferase were measured and complete blood counts were obtained at each visit during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Frequent relapse nephrotic syndrome
- •steroid resistance nephrotic syndrome
排除标准
- •secondary nephrotic syndrome
- •estimated glomerular filtration rate < 60 mL/min/1.73m2
- •with active hepatitis
研究组 & 干预措施
Tacrolimus
Tacrobell
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Remission Rate
时间窗: 12-month treatment period
Complete remission at 12 months Per KDIGO clinical practice guideline for glomerulonephritis (2012): Complete remission (CR), urine protein creatinine ratio below 200mg/g (20mg/mmol) or 1+ of protein on urine dipstick for 3 consecutative days
次要结局
- Duration of Remission(12-month treatment period)
研究者
Il Soo Ha
Study chair
Seoul National University Hospital