临床试验/EUCTR2017-000826-36-FR

EUCTR2017-000826-36-FR进行中（未招募）1 期

Efficacy and safety of immunoglobulin associated with rituximab versus rituximab alone in Childhood-Onset steroid-dependent nephrotic syndrome - RITUXIVIG

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 90 人开始时间: 2018年3月21日最近更新: 2018年5月28日

适应症

相关药物

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
入组人数: 90

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•- Childhood onset nephrotic syndrome (first flair at age> 2 years and <18 years)
•- 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 steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide) or following 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)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 80
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

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 infection;
•- Pregnancy or breastfeeding.
•- Patients with hyperprolinaemia,
•- Known hypersensitivity to one of the study medication,
•- Scheduled and not postponable injection of live attenuated vaccine

研究者

发起方

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

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