CTRI/2025/03/083231尚未招募2/3 期
Efficacy of low dose prednisolone in children with steroid sensitive nephrotic syndrome - An open labelled randomized pilot trial
Aiims Bathinda1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年4月1日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Rate of relapses in steroid sensitive nephrotic syndrome on low dose prednisolone
研究概览
简要总结
This open-label randomized controlled trial will be conducted over 18 months aiming to evaluate the effectiveness to reduced doses of prednisolone during relapses in steroid sensitive nephrotic syndrome (SSNS) in children aged 2-13 years. The intervention group will receive low dose prednisolone 1.5mg/kg/day until remission, followed bt 1.5mg/kg alternate day for 2 weeks and 1mg/kg alternate day for next 2 weeks and the control group will receive the standard regimen 2mg/kg/day until remission,followed by 1.5 mg /kg alternate day for 4 weeks. The primary outcome is the rate of relapses in SSNS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 13.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged between 2 to 13 years present to pediatric OPD or IPD with steroid sensitive nephrotic syndrome.
- •Those in relapse 3)Those patients who were not receiving prednisone at the time of relapse and had never before received other steroid sparing drugs.
排除标准
- •Steroid resistant and steroid dependent 2)Patient with nephrotic syndrome due to secondary causes.
- •Patients with frequent relapses 4)Patients in whom initial episode was not treated with at least 2 mg/kg of daily steroids for 4 weeks followed by 4 weeks of 1.5 mg/kg alternate day steroids during.
结局指标
主要结局
Rate of relapses in steroid sensitive nephrotic syndrome on low dose prednisolone
时间窗: 1 year
次要结局
- 1)Comparison of steroid toxicity in both the groups.(2)Difference in Linear growth with both the regimen)
研究者
Dr Onkar Singh
AIIMS BATHINDA
研究点 (1)
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