临床试验/NCT00308321

NCT00308321Unknown4 期

Long Term Tapering or Standard Steroids for Nephrotic Syndrome

Institute of Child Health2 个研究点分布在 1 个国家目标入组 50 人开始时间: 2003年9月1日最近更新: 2007年11月29日

适应症

试验速览

阶段: 4 期
发起方: Institute of Child Health
入组人数: 50
试验地点: 2
主要终点: Time to first relapse

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Parallel group double blind randomised in patients with first episode corticosteroid sensitive nephrotic syndrome comparing time to relapse and adverse effects associated with a longer tapering steroid regimen with standard regime

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: 1 Year 至 15 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•newly presenting nephrotic syndrome, urine albumin/protein creatinine ratio >200mg/mmol on early morning urine sample, hypoalbuminemia (<25g/L)

排除标准

•prior treatment with steroids or cytotoxic agents underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome

结局指标

主要结局

Time to first relapse

时间窗: 5 months

Assessment of steroid induced morbidity

时间窗: 5 months

次要结局

frequent relapsing and steroid dependant disease(5 months)
Time to relapse(5 months)
serious adverse events(5 months)
use of other immunosuppressive agents(5 months)
Achenbach child behaviour checklist(5 months)

研究者

发起方

Institute of Child Health

申办方类型

Other

研究点 (2)

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