CTRI/2012/12/003194招募中4 期
Open label, randomized, controlled trial to compare the efficacy of daily therapy with low dose prednisolone versus standard therapy on alternate days in patients with frequently relapsing/ steroid dependent nephrotic syndrome
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
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
- •Children aged 2-16 years with frequently relapsing/steroid dependent nephrotic syndrome.
排除标准
- •Steroid resistant nephrotic syndrome, congenital nephrotic syndrome
- •Nephrotic syndrome secondary to systemic disease (systemic lupus erythematosus, IgA nephropathy, infection with HIV or hepatitis B or C.
- •Intake of immunosuppressive medications other than oral prednisolone in the preceding 6 months
- •One or more features of steroid toxicity, as defined by body mass index >95th percentile for age and gender, presence of cataract or stage 2 hypertension.
- •Refusal of informed parental consent
- •High steroid threshold to prevent relapses ( >1 mg/kg on alternate days)
- •Recent ( <6 months) relapse associated with need of hospital admission e.g. for severe life threatening infection
- •Occurrence of more than two relapses during any 6-months, or 3 or more relapses in 12 months while receiving intervention, will be taken as trial deviate and require initiation of alternative therapy.
- •Occurrence of late resistance to corticosteroids
- •Subjects in whom the intervention cannot be given for one year, or is interrupted for more than two weeks period of time; e.g. subjects who become very sick and have to be withdrawn from the study
研究者
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