A prospective, sequential study to assess the efficacy of rituximab therapy in maintaining remission of nephrotic syndrome after steroid and immunosuppressive therapy withdrawal in patients with steroid-dependant or multirelapsing minimal change disease or focal segmental glomerulosclerosis - NEMO

IST. DI RICERCHE FARMACOLOG. M. NEGRI0 个研究点目标入组 20 人开始时间: 2009年1月27日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•- Males and females > 10 years - Steroid-dependent or multirelapsing NS (defined on the basis of the occurrence of more than 2 relapses in the previous year in spite of steroid and/or other immunosuppressive therapy). Only patients reported to invariably relapse upon treatment tapering or withdrawal who are on stable (from at least 1 month) complete (<0.3 g/24h for adults or <4 mg/h/m2 for children) or partial (<3.5 g/24h for adults or <40 mg/h/m2 for children) remission of the NS will be included; - Histological diagnosis of MCD or FSGS; - Written informed consent (or consent from parents or tutors for underage patients).
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Advanced renal failure (creatinine clearance less than 20 ml/min/1.73m2); - Evidence of B or C virus infection; - Refractory or persistent NS; - Genetic mutations associated with intrinsic abnormalities of the glomerular barrier that would hardly be affected by rituximab treatment; - Pregnancy or lactating; - Women of childbearing potential without following a scientifically accepted form of contraception; - Legal incapacity; - Evidence of an uncooperative attitude; - Previous diagnosis of: intellectual disability/mental retardation, dementia, schizophrenia. - Any evidence that patient will not be able to complete the trial follow-up.

发起方

IST. DI RICERCHE FARMACOLOG. M. NEGRI