CTRI/2020/09/028055进行中（未招募）2 期
A multicenter randomized control trial to compare the efficacy and safety of single dose versus two doses of rituximab in patients 2-12 years of age with steroid dependant or frequently relapsing nephrotic syndrome who has failed atleast two steroid sparing agents - the RIT-TIC trial (RITuximab in nephroTIC)
Institute of Child Health Kolkata AND Medical College Kolkata0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients with idiopathic nephrotic syndrome with steroid dependence or frequent relapses who has failed at least two steroid sparing agents, last one being failed in previous 3 months
- •2. Patients is in remission state of the disease
- •3. Legal guardian is willing to give informed written consent
排除标准
- •1.Prior therapy with rituximab in last one year
- •2.Historical steroid resistance in last one year
- •3.Hepatitis B and C serology positive
- •4.Acute or chronic active infection
- •5.Chronic lung disease or uncontrolled asthma
- •6.Leucopenia or thrombocytopenia
- •7.Expected rituximab first infusion date less than 4 weeks from a live vaccination
- •8.Documented intolerance to mycophenolate in past
- •9.eGFR < 60 ml/min/1.73m2
- •10.Regular follow-up not feasible
研究者
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