Clinical Trial

A Trial to Assess the Efficacy and Safety of Obinutuzumab in Treating Adults With Minimal Change Disease (MCD)

Study acronym: OBELIX-NS
Recruiting Phase 2
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Summary
OBELIX-NEPHROSIS (NS) The goal of this clinical trial is to learn if obinutuzumab works to treat minimal change disease in adults. It will also learn about the safety of drug obinutuzumab. The main questions it aims to answer are: Is obinutuzumab non-inferior to glucocorticoids at inducing remission? Does obinutuzumab provide superiority in terms of relapse-free survival after 52 weeks? What medical problems do participants have when receiving obinutuzumab? Researchers will compare drug obinutuzumab to glucocorticoids and aim to phenotype participants with minimal change disease. Participants will: Take the drug obinutuzumab (2 doses) or glucocorticoids Visit the clinic for 8 visits over a period of 52 weeks, plus additional controls when disease relapses occur
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-07-13; most recent amendment 2026-07-20.
Trial Details
NCT Number NCT07710157
Lead Sponsor Medical University Innsbruck
Collaborators: Henri Mondor University Hospital, Centre Hospitalier Universitaire de Nice, Medical University of Graz, WiGeV Klinik Ottakring, Universitätsklinikum Hamburg-Eppendorf
Conditions Minimal Change Disease (MCD)
Enrollment 48 participants
Start Date 2026-07-13
Primary Completion 2028-06-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-21