Obinutuzumab versus Rituximab to maintain remission in children with steroid-dependent and frequently relapsing nephrotic syndrome: the OBIRINS study protocol, a double-blind randomised controlled trial.

ABSTRACT:

Introduction

There is an unmet clinical need for the development of novel treatment strategies to improve the outcome of children with frequent relapsing or steroid-dependent nephrotic syndrome. Obinutuzumab (OBI) is a second-generation anti-CD20 monoclonal antibody that has demonstrated its superiority to rituximab (RTX) in vitro and in vivo. Our assumption is that a single infusion of low-dose OBI will induce longer B-cell depletion, longer sustained remission and reduce the frequency of relapses and the use of oral immunosuppressors compared with a single infusion of RTX.

Methods and analysis

We conduct a double-blind, multicentre, randomised, parallel group in a 1:1 ratio controlled trial. In the experimental group, patients receive 1 infusion of OBI (300 mg/1.73 m²

SUBMITTER: Dossier C 

PROVIDER: S-EPMC12742136 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature