RecruitingPhase 2NCT07710157

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

A Randomized Controlled, Two-arm (1:1 Ratio) Phase IIa Trial to Assess the Efficacy and Safety of Obinutuzumab in Treating Adults With de Novo Minimal Change Disease


Sponsor

Medical University Innsbruck

Enrollment

48 participants

Start Date

Jul 13, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Obinutuzumab Injection and a drug called Predniso(lo)ne for people with minimal change disease (mcd). The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGObinutuzumab Injection

Obinutuzumab (2-times, 1 g each) will be administered

DRUGPredniso(lo)ne

Predniso(lo)ne will be used as the active comparator, with a planned withdrawal after 6 months


Locations(6)

Division of Nephrology, Department of Internal Medicine, Medical University of Graz

Graz, Austria

Department of Internal Medicine IV, Nephrology and Hypertension

Innsbruck, Austria

6. Medizinische Abteilung mit Nephrologie & Dialyse, Klinik Ottakring

Vienna, Austria

Laboratory of Immunology, Nice University Hospital (CHU de Nice), Côte d'Azur University

Nice, France

Hôpital Henri-Mondor

Paris, France

III. Department of Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, Germany

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NCT07710157


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