NCT03501459招募中3 期
Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome
National University Health System, Singapore1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Response
研究概览
简要总结
The purpose of this study is to investigate if lymphocyte markers predict response to rituximab among patients with idiopathic nephrotic syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1-18 years old at the time of diagnosis of nephrotic syndrome
- •Steroid-dependent (SDNS) or steroid-resistant nephrotic syndrome (SDNS)
排除标准
- •eGFR <60 ml/min per 1.73m2
- •infantile onset of nephrotic syndrome
- •nephrotic syndrome secondary to chronic infections such as hepatitis B, hepatitis C or human immunodeficiency virus, systemic lupus erythematosus, Henoch-Schönlein purpura, IgA nephropathy, membranoproliferative glomerulonephritis or membranous nephropathy
- •current or previous therapy for tuberculosis
- •presence of mutations in WT1, NPHS1, NPHS2 and TRPC6.
研究组 & 干预措施
Rituximab
Experimental
干预措施: Rituximab (Drug)
结局指标
主要结局
Response
时间窗: 3 months
Resolution of proteinuria (urine protein:creatinine \<0.02 g/mmol or urine protein excretion \<0.3 g/1.73m2/day) and ability to wean off prednisolone and calcineurin inhibitor at three months after the last dose of rituximab.
次要结局
未报告次要终点
研究者
Isaac Liu
Professor Yap Hui Kim
National University Health System, Singapore
研究点 (1)
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