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