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

Recruiting Phase 2 Phase 3 Interventional Study
Steroid-Dependent Nephrotic Syndrome Steroid-Sensitive Nephrotic Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
3 – 18
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
88 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age between 3 and 18 years * Steroid dependant Nephrotic Syndrome defined as: * 2 or more relapses during steroids or within 2 weeks following discontinuation. * 2 or more relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, l…
Contacts

Claire DOSSIER, MD

+33140032467

claire.dossier@aphp.fr

CONTACT

Julien HOGAN, MD PhD

+33140032142

julien.hogan2@aphp.fr

CONTACT