Randomized, double blind, placebo controlled trial to compare the efficacy of 3-months versus 6-months therapy with prednisolone for the first episode of idiopathic nephrotic syndrome in children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 168
- 试验地点
- 5
- 主要终点
- The occurrence of relapse during one year follow up, in patients receiving 6 months versus 3 months of prednisolone therapy for the initial episode of nephrotic syndrome
研究概览
简要总结
This study is a randomized, double blind, parallel group, multicentric trial comparing the safety and efficacy of therapy of initial episode of nephrotic syndrome with prednisolone for three months versus six months, following standard therapy with prednisolone for three months, patients will receive either prednisolone or placebo in tapering doses on alternate days for three months. The study shall be conducted at one center in India. The primary outcome measure is the comparison of relapse rates in the two groups of patients over the next one year, while secondary outcomes include the time to first relapse (in days) after discontinuation of initial treatment, the proportion of patients with frequent relapses at 1 year & 2 years of follow up, the cumulative prednisolone requirement (mg/kg/day) at 1 year, the use of alternative medications at 1 year, and the side effects of corticosteroids at the end of initial therapy and at 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with idiopathic, steroid sensitive nephrotic syndrome
- •First episode of nephrotic syndrome
- •Age 1 to 12 years.
排除标准
- •1.Nephrotic syndrome known to be secondary to a systemic disorder, e.g., IgA nephropathy, systemic lupus erythematosus, Henoch Schonlein purpura, vasculitis, amyloidosis, hepatitis B antigenemia and Alport syndrome.2.Patients with impaired renal functions (serum creatinine > 1.2 mg/dl, confirmed within 2 weeks)3.Patients who have received oral prednisolone, in the past for nephrotic syndrome4.Patients who have taken prednisolone in the past 4 weeks, in a dose more than 1 mg/kg for >10 days for any other reason5.Unclear treatment history.6.Patients staying more than 100 km from the Institute or those not willing to come for clinic visits every two months7.Gross hematuria8.Patients with initial steroid resistance9.Patients who show relapse within the first 3 months of therapy.
结局指标
主要结局
The occurrence of relapse during one year follow up, in patients receiving 6 months versus 3 months of prednisolone therapy for the initial episode of nephrotic syndrome
时间窗: one year after cessation of therapy with prednisolone
次要结局
- 1)The time to first relapse (days) after discontinuation of initial treatment(2)The proportion of patients with frequent relapses at 1 year, after discontinuation of initial therapy)