jRCTs051200070已完成不适用
Efficacy of mizoribine after two years of cyclosporine treatment for children with frequently relapsing nephrotic syndrome
未提供0 个研究点目标入组 20 人开始时间: 2020年12月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 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
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 3age old over 至 No limit（—）
- 性别
- All
入选标准
- •Written informed consent from the patients' parents or legal guardians.
- •Treated with 2-year cyclosporine after diagnosis of frequently relapsing nephrotic syndrome between one and 18 years of age.
- •Patients in remission at enrollment.
- •Patients with more than 3,000/mm^3 blood leukocytes
排除标准
- •Prior treatment other than cyclosporine or steroids at relapse for frequent relapsing nephrotic syndrome
- •History of secondary nephrotic syndrome by other nephritis or systemic disease revealed by renal biopsy, clinical findings or blood tests
- •Frequency relapse while taking cyclosporine
- •4.Immunosuppressive drugs other than cyclosporine
- •5.Uncontrollable hypertension
- •6.Renal dysfunction(CCr<=60ml/min/1.73m2)
- •7.Active infectious disease
- •8.Schedule of live vaccine administration during this study
- •9.Severe liver dysfunction
- •10.Pregnant women
- •11.Otherwise judged inappropriate for this study by the physicians
结局指标
主要结局
-
Rate of regression to treatment failure up to 52 weeks after starting cyclosporine weight loss
次要结局
- Period of progression to treatment failure
- Recurrence-free rate
- Recurrence-free period
- Rate of regression to treatment failure
- The blood level of mizoribine
- Safety of mizoribine