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RECRUITING
NCT05786768
PHASE2/PHASE3

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

3 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2023-10-18

Completion Date

2027-12-31

Last Updated

2023-11-09

Healthy Volunteers

No

Interventions

DRUG

single infusion of Rituximab

single infusion of Rituximab 375 mg/m2

DRUG

single infusion of Obinutuzumab

single infusion of Obinutuzumab 300mg/1.73 m2

Locations (1)

Robert Debre Hospital

Paris, France