Two Anti-CD20 Regimens for Fibrillary Glomerulonephritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- renal responce
研究概览
简要总结
This study aims to evaluate the clinical and histological effects of two rituximab-based regimens in fibrillary glomerulonephritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fibrillary glomerulonephritis (biospy proven defined by optical microscopy, immunofluorescence and electron microscopy studies with demonstration of the DNAJB9 protein)
排除标准
- •previous treatment with anti-CD20; pregnant; unable to consent. other concomitant GN.
研究组 & 干预措施
Anti-CD20 alone
Lymphoma Protocol consisting of four weekly doses of 375 mg/m2 of rituximab (RTX)
干预措施: Anti-CD20 antibodies (Drug)
IBCDT
Intensive B-cell depletion therapy (IBCDT) which is based on the combination of RTX (given at the dose of 375 mg/m2 every 4 weeks followed by 2 additional doses after 1 and 2 months), CYC (two pulses of 10 mg/kg, corrected according to renal function, on days 4 and 17) and methylprednisolone (three bolus doses of 15 mg/kg) followed by oral prednisone (starting dose 50 mg tapered until complete discontinuation in 4 months).
干预措施: Anti-CD20 antibodies (Drug)
结局指标
主要结局
renal responce
时间窗: 0, 3 and 6 months
complete remission (CR), i.e., decrease of proteinuria to \<0.5g/day with normal or stable renal function (\< 20% increase in serum creatinine); partial remission (PR), i.e., reduction in proteinuria by ≥50% with stable renal function
次要结局
未报告次要终点