CTRI/2015/01/005364招募中3 期
Efficacy and Safety of Rituximab to that of Calcineurin Inhibitors in Children with Steroid Resistant Nephrotic Syndrome
RS Medical College and Hospital0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
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 between 3 and 16 years with SRNS
- •Minimal Change disease/MesPGN/FSGS as per Kidney Biopsy report.
- •Estimated glomerular filtration rate (eGFR) >80 ml/min per 1.73 m2 at study entry.
- •Not received any steroid sparing agent previously.
- •Parents willing to give informed written consent.
- •Ability to swallow tablet
排除标准
- •Known etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis, malignancy, other secondary forms of NS)
- •Patients with severe leucopenia (leucocytes <3.0Ã? 1000 cells/mm3), severe anemia (haemoglobin <8.9 g/dl), thrombocytopenia (platelet <100.0 Ã? 1000 cells/mm3) or deranged liver function tests (AST or ALT to >50 IU/L ) at enrolment.
- •Known active chronic infection (tuberculosis, HIV, hepatitis B or C)
- •Live vaccination within 1 mo.
研究者
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