Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The occurrence of the first relapse
研究概览
简要总结
Idiopathic Nephrotic Syndrome (INS) is the first glomerulopathy in children and 60% of the patients develop Steroid-Dependant Nephrotic Syndrome (SDNS). Recently, rituximab (RTX), a humanized anti-CD20 antibody depleting B cells demonstrated the ability to increase relapse free survival and to decrease the number of relapse and the need of other immunosuppressive drugs. However, the remission rate after 2 years is only 30 to 40%.
The aim of the study is to study the ability of intravenous Immunoglobulin to improve remission rate in SDNS when added associated with Rituximab compared to a treatment by Rituximab alone.
详细描述
Idiopathic Nephrotic Syndrome (INS) is the first glomerulopathy in children and 60% of the patients develop Steroid-Dependant Nephrotic Syndrome (SDNS). Depleting B cells demonstrated the ability to increase relapse free survival and to decrease the number of relapse and the need of other immunosuppressive drugs. However, the remission rate after 2 years is only 30 to 40%.
The aim of the study is to study the ability of intravenous Immunoglobulin to improve remission rate in SDNS when added associated with Rituximab compared to a treatment by Rituximab alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 2 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Childhood onset nephrotic syndrome (first flair <18 years)
- •≥ 2 years old at inclusion
- •Steroid-dependent:
- •Patient with at least 2 relapses confirmed during the decay of corticosteroids or within 2 weeks following steroids discontinuation.
- •Patient with at least 2 relapses including one under steroidsparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, Levamisole) or within 6 months of treatment withdrawal.
- •or with frequent relapses:
- •· 2 or more relapses within 6 months after initial remission or 4 or more relapses within any 12-month period.
- •with a relapse within 3 months prior to inclusion
- •In remission: Protein-over-creatinine ratio ≤ 0.2g/g (≤ 0.02g/mmol)
排除标准
- •Patients with steroid-resistant nephrotic syndrome;
- •Patients with genetic nephrotic syndrome;
- •Patients previously treated with rituximab;
- •Patients with no affiliation to a social security scheme (beneficiary or legal);
- •Prior Hepatitis B, Hepatitis C or HIV infection;
- •Pregnancy or breastfeeding.
- •Patients with hyperprolinaemia,
- •Known hypersensitivity to one of the study medication,
- •Scheduled and not postponable injection of live attenuated vaccine
- •Protected adults
- •Patients with neutrophils < 1.5 G/L and/or platelets < 75 G/L
研究组 & 干预措施
Rituximab followed by 5 injections of immunoglobulin IV
Rituximab (375 mg/m²) followed by 5 injections of immunoglobulin IV once a month during 5 months (2g/kg at M1, 1.5g/kg at M2 to M5, maximal dose 100g). Treatment duration : 6 months
干预措施: immunoglobulin IV (Drug)
结局指标
主要结局
The occurrence of the first relapse
时间窗: 24 months
Relapse is defined as a protein to creatinine ratio of 2g/g of creatinine (0.2 g/mmol) or higher
次要结局
- Time to first relapse(24 months)
- Number of relapse over a 24 months follow-up(24 months)
- Cumulative amount of corticosteroid over a 24 months follow-up(24 months)
- Adverse events in each arm(24 months)