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RECRUITING
NCT07710157
PHASE2

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

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-07-13

Completion Date

2029-06-30

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

DRUG

Obinutuzumab Injection

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

DRUG

Predniso(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