CTRI/2022/10/046891尚未招募4 期
Efficacy and Safety of Mycophenolate Mofetil versus Oral Cyclophosphamide in Children with Frequently Relapsing or Steroid Dependent Nephrotic Syndrome: An Open Label Randomized Controlled Trial
AIIMS New Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
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 nephrotic syndrome with frequent relapses or steroid dependence in the preceding 12-months and with parents willing to give informed written consent and child giving informed written assent
排除标准
- •Known secondary etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis)
- •Initial or late steroid resistance, currently or historically
- •Therapy with oral or intravenous cyclophosphamide or MMF ever in the past
- •Therapy with cyclosporine, tacrolimus, azathioprine or rituximab in the past 6 months
- •Inability to swallow tablets or capsules of MMF
- •Impaired renal function, as indicated by eGFR <60 mL/min per 1.73 m²
- •Leukopenia, neutropenia, thrombocytopenia, elevated transaminases
- •Known chronic infection (tuberculosis, HIV, hepatitis B or C) or malignancy
- •Residing more than 100 km away or unwilling to come for regular follow-up
研究者
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