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

Phase 1

• Conditions: ephrotic Syndrome secondary to minimal change disease (MCD) or idiopathic focal and segmental glomerulosclerosis (FSGS.; MedDRA version: 9.1 Level: LLT Classification code 10029171; MedDRA version: 9.1 Level: LLT Classification code 10058326; MedDRA version: 9.1 Level: LLT Classification code 10016832

• Registration Number: EUCTR2008-006750-17-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-27
• Study Completion: 2012-07-16
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified