RecruitingPhase 2Phase 3NCT05786768

Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome

Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome : a Double-blind Multicenter Randomized Controlled Study


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

88 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

B-cell depletion with rituximab induces sustained remission in children with Steroid-Dependent or Frequent Relapsing Nephrotic Syndrome (SD/FRNS). However, most patients relapse after B-cell recovery and some do not achieve B-cell depletion. Obinutuzumab is a 2nd generation humanized monoclonal antiCD20 antibody, with enhanced B cell-depleting potential. It has been reported safe and efficient in different renal autoimmune diseases including childhood nephrotic syndrome. This double-blind, randomized multicenter study is designed to assess the efficacy and safety of a single infusion of low-dose obinutuzumab compared to a single infusion of rituximab in children with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).


Eligibility

Min Age: 3 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called single infusion of Obinutuzumab and a drug called single infusion of Rituximab for people with steroid-dependent nephrotic syndrome and steroid-sensitive nephrotic syndrome. The study is currently recruiting participants at 1 location. People eligible for this study include aged 3 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGsingle infusion of Rituximab

single infusion of Rituximab 375 mg/m2

DRUGsingle infusion of Obinutuzumab

single infusion of Obinutuzumab 300mg/1.73 m2


Locations(1)

Robert Debre Hospital

Paris, France

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NCT05786768


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