jRCT2011220036进行中（未招募）不适用
A PHASE III, INTERNATIONAL, MULTICENTER, RANDOMISED OPEN LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB VERSUS MMF IN PATIENTS WITH CHILDHOOD ONSET IDIOPATHIC NEPHROTIC SYNDROME
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 2age old over 至 25age old under（—）
- 性别
- All
入选标准
- •Diagnosis of FRNS or SDNS before the age of 18 years
- •Must be in complete remission defined by the absence of edema, UPCR =< 0.2 g/g at screening, and have three consecutive daily urine dipstick readings of trace or negative for protein within the week prior to randomization
- •Must have had at least one relapse in the 6 months prior to screening, after discontinuation of or while receiving oral corticosteroids and/or immunosuppressive therapy to prevent relapses
- •Estimated glomerular filtration rate (eGFR) within normal range for age
排除标准
- •Secondary nephrotic syndrome
- •History of steroid resistant nephrotic syndrome
- •History of genetic defects known to directly cause nephrotic syndrome
- •Treatment with other immunosuppressive medications to prevent relapse, other than MMF or oral corticosteroids within 2 months prior to randomization
- •Participants demonstrating prior treatment failure to MMF as defined by two or more relapses in any 6-month period of time while receiving MMF for at least a 6-month duration
- •Participants in the judgment of the investigator likely to require systemic corticosteroids for reasons other than idiopathic nephrotic syndrome during the study
结局指标
主要结局
-
Efficacy Percentage of Participants with Sustained Complete Remission at 1 year
次要结局
未报告次要终点
研究者
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