CTRI/2017/12/010830招募中3 期
A 12-Week Placebo-Controlled Randomized Trial of Oral Galactose for Reduction of Proteinuria in Children with Multi-Drug Resistant Nephrotic Syndrome - GALANT
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- yes
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
- •1.Age 1-18 years
- •2.Multidrug resistant nephrotic syndrome as demonstrated by non-responsiveness to oral prednisolone 60mg/m2/day given for 4 weeks and non-responsiveness to tacrolimus or ciclosporin given for at least 3 months (uPCR > 2 mg/mg).
- •3.Biopsy proven focal segmental glomerulosclerosisor minimal change nephropathy
- •4.eGFR >60ml/min/1.73m2, stable during the preceding 3 months
- •5.Discontinuation of immunosuppressive medications at least 1 month prior to screening
- •6.Stable RAS antagonist (ACE inhibitor or AT1 receptor blocker) therapy (no dose change during previous month)
排除标准
- •1.Galactosemia or other disorder of carbohydrate metabolism
- •2.Type 1 diabetes mellitus
- •3.Secondary MDR-NS due to HIV, Hepatitis B, tuberculosis
- •4.Chronic kidney disease stage III-V
- •5.Expected non-compliance with medications
研究者
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