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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Obinutuzumab (2-times, 1 g each) will be administered
Predniso(lo)ne will be used as the active comparator, with a planned withdrawal after 6 months
Division of Nephrology, Department of Internal Medicine, Medical University of Graz
Graz, Austria
RECRUITINGDepartment of Internal Medicine IV, Nephrology and Hypertension
Innsbruck, Austria
RECRUITING6. Medizinische Abteilung mit Nephrologie & Dialyse, Klinik Ottakring
Vienna, Austria
NOT_YET_RECRUITINGLaboratory of Immunology, Nice University Hospital (CHU de Nice), Côte d'Azur University
Nice, France
NOT_YET_RECRUITINGHôpital Henri-Mondor
Paris, France
NOT_YET_RECRUITINGRobert Bosch Krankenhaus, Department of General Internal Medicine and Nephrology
Stuttgart, Germany
NOT_YET_RECRUITINGNon-inferiority of obinutuzumab to SoC predniso(lo)ne taper: Proportions of patients achieving remission (complete or partial) of MCD at 8 weeks
Time frame: From enrollment to the end of treatment at 8 weeks
Superiority of obinutuzumab to SoC predniso(lo)ne taper: Proportions of patients sustaining remission (complete or partial)/prevent relapses of MCD during the study period of 52 weeks
Time frame: From enrollment to the end of treatment at 52 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.