Condition: Steroid-Dependent Nephrotic Syndrome · Steroid-Sensitive Nephrotic Syndrome · Sponsor: Assistance Publique - Hôpitaux de Paris
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).
This description comes directly from the study's public registry record.
Claire DOSSIER, MD · +33140032467 · claire.dossier@aphp.fr
Julien HOGAN, MD PhD · +33140032142 · julien.hogan2@aphp.fr
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| Robert Debre Hospital | Paris, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05786768