Oral methylprednisolone versus prednisolone: A pilot randomised control trial in treatment of first episode nephrotic syndrome in children, non-inferiority trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Comparative study of time taken to achieve remission from first episode of Nephrotic syndrome Between two drugs
研究概览
简要总结
Nephrotic syndrome is the commonest glomerular disease in children. Corticosteroids are the first line treatment. Almost 80% shows steroid responsiveness and achieve complete remission in 4 weeks. Oral prednisolone for 8-12 weeks (as per KDIGO 2021 GUIDELINES) are used. Methyl prednisolone being a corticosteroid, with 1.25 times glucocorticoid effect and 0.625 times mineralocorticoid effect compared to prednisolone when given in equivalent dose can show low Na+ retention and there will be less chances of developing hypertension.
Considering lesser sodium retaining activity, methyl prednisolone might have lesser side effects as compared to prednisolone. The aim of this study is to compare the effectiveness and safety of methylprednisolone in children with first episode of idiopathic nephrotic syndrome in a prospective randomized controlled trial. Although studies on IV methylprednisolone have been done for treatment of primary nephrotic syndrome but study on oral methylprednisolone is limited.
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
- 4.00 Year(s) 至 14.00 Year(s)(—)
- 性别
- All
入选标准
- •children between the ages of 4 and 14 years old with primary diagnosis of nephrotic syndrome first attack.
排除标准
- •children less than 4 years or more than 14 years, children having hypertension, hematuria, raised creatinine level or with secondary nephrotic syndrome due to any systemic disorder or drug.
结局指标
主要结局
Comparative study of time taken to achieve remission from first episode of Nephrotic syndrome Between two drugs
时间窗: 4 weeks
次要结局
- Number of relapses during one year follow up(one year)
研究者
Aishwarya Chandra
SCB Medical College and Hospital
