CTRI/2025/10/096742尚未招募2 期
Randomized controlled trial to compare the efficacy of two doses of Rituximab versus Tacrolimus for maintenance of remission in difficult to treat SDNS
Dr Anannya Biswas1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月2日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Remission rate
研究概览
简要总结
This study is a randomised, parallel group, trial comparing efficacy of two doses of rituxumab and tacrolimus in children (3-12 years age group) with difficult to treat steroid dependent nephrotic syndrome. The sample size of the study is 30 patients in each group. The primary outcome measure will be remission rate (complete or partial remission for at least 6 months) at 12 months. The secondary outcomes will be time to remission achieved, steroid sparing efficact , relapse rate , side effects and adverse events, quality of life.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with difficult to treat Steroid dependent nephrotic syndrome: Any 1 criteria met
- •Frequent relapses (Greater than or equal to 2 relapses in 6 months or greater than or equal to 3 relapses in 1 year) or steroid dependence
- •Failure of greater than or equal to 2 strategies ( alternate day prednisolone, levamisole, cyclophosphamide, MMF )
- •Corticosteroid toxicity ( cataract , glaucoma ,short stature , low growth velocity , obesity ).
排除标准
- •Active infection or history of recurrent severe infections.
- •Prior exposure to rituximab.
- •Severe cardiovascular or hepatic disease.
- •Uncontrolled comorbid conditions (e.g., diabetes, hypertension).
结局指标
主要结局
Remission rate
时间窗: 12 months
次要结局
- Time to remission
- Relapse rate(12 months)
- Steroid sparing effect(12 months)
- Side effects and adverse events(12 months)
- Quality of life(12 months)
研究者
Dr Anannya Biswas
IPGMER AND SSKM Hospital
研究点 (1)
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