Effectiveness of single dose versus dual dose Rituximab in difficult-to-treat, steroid dependent nephrotic syndrome in children: A single blind Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- We anticipate that single-dose Rituximab (375 mg/m²) will be non-inferior to double-dose Rituximab( two doses of 375mg/m2 given in 1week interval) in maintaining relapse-free remission in children with difficult-to-treat steroid-dependent nephrotic syndrome (SDNS).
研究概览
简要总结
A randomized control trial has been planned. In Arm 1 we have the intervention group where Injection Rituximab will be given in the first week and in second week Normal Saline infusion will be given as placebo. In arm 2 we will give Inj Rituximab 1st dose in week 1 and 2nd dose in week 2. CD 19 counts will be measured 7 days after giving Rituximab then at 6 months or at time of relapse whichever is earlier. Follow up done till 12 months. Primary and secondary outcomes will be measured at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •All pediatric patients diagnosed with difficult to treat SDNS attending OPD/ IPD of department of pediatrics, IPGME&R aged 3 years to 12 years.
排除标准
- •Congenital nephrotic syndrome patients, aged less than 3 months Nephrotic syndrome secondary to causes like , sickle cell disease, HIV, systemic lupus erythematosus, hepatitis B, malaria, parvovirus B19, medications Patients with Hep B core antibody total positive, since Rituximab can lead to reactivation of latent hepatitis B virus.
- •Incomplete records Did not give consent.
结局指标
主要结局
We anticipate that single-dose Rituximab (375 mg/m²) will be non-inferior to double-dose Rituximab( two doses of 375mg/m2 given in 1week interval) in maintaining relapse-free remission in children with difficult-to-treat steroid-dependent nephrotic syndrome (SDNS).
时间窗: 18 months
The time to first relapse and the number of relapses in a year will be similar between the single-dose and double-dose groups.
时间窗: 18 months
次要结局
- 1. Reduction in cumulative steroid exposure will be similar between both groups, indicating effective steroid-sparing action even with a single dose.(2. B-cell depletion and reconstitution timelines may differ, but without a significant impact on clinical remission rates.)
研究者
Renaissa Banik
IPGMER and SSKMH