CTRI/2015/06/005939尚未招募3 期
Randomized, multicentric, open label, parallel group trial to compare the efficacy of 6-months versus 3-months therapy with prednisolone for the first episode of idiopathic nephrotic syndrome in children younger than 4 years - SSNS
Arvind Bagga0 个研究点目标入组 156 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients with idiopathic, steroid sensitive, first episode of nephrotic syndrome, 1 to 4 years old, shall be included.
排除标准
- •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.
- •Patients with impaired renal functions (serum creatinine >1.2 mg/dl, confirmed in 2 weeks)
- •Patients who have received oral prednisolone, in the past for nephrotic syndrome
- •Patients who have taken prednisolone in the past 4 weeks, in a dose more than 1 mg/kg for >10 days for any other reason
- •Unclear treatment history
- •Patients staying more than 100 km from the Institute or those not willing to come for clinic visits every two months
- •Gross hematuria
- •Patients with initial steroid resistance
- •Patients who show relapse during the first 3 months of therapy (standard therapy)
研究者
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