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Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome | Clinical Trials | Clareo Health

SUSPENDEDPHASE2/PHASE3

Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome

NCT03560011•Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

2 - 25 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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)

Exclusion Criteria

•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
+1 more criteria

Locations (1)

Robert Debre Hospital

Paris, France

Key Dates

Start Date

April 3, 2019

Primary Completion Date

January 7, 2021

Completion Date

November 4, 2022

Last Updated

October 4, 2021

Enrollment

ESTIMATED participants

Conditions

Steroid-Dependent Nephrotic Syndrome

Interventions

immunoglobulin IV

DRUG

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Steroid-Dependent Nephrotic SyndromeSteroid-Sensitive Nephrotic Syndrome

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NOT_YET_RECRUITINGEARLY_PHASE1

Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Steroid - Dependent /Steroid-resistant Nephrotic Syndrome in Children

NCT07003438

Steroid-Resistant Nephrotic SyndromeSteroid-Dependent Nephrotic Syndrome

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 4, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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