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
Understands and agrees to comply with the study procedures and provides informed consent as documented by signature
Male or female patients aged 18 years or older at the time of consent
Confirmed first episode of nephrotic syndrome at trial enrolment (serum albumin <30g/l and UPCR >3g/g creatinine (>300 mg/mmol) secondary to de novo MCD
Histologically confirmed MCD (latest before randomization to Arm A or B)
MCD due to secondary causes, including malignancy of a type likely to be associated with MCD (i.e., lymphoproliferative disorders), or potentially related to treatment known to be associated with MCD occurrence (lithium, interferon, non-steroidal anti-inflammatory drugs)
Family history of MCD or in a first degree relative unless previously shown to be steroid-responsive
Previous B cell depletion, independent of the agent and treatment target (i.e., CD20, CD38, etc.), within 18 months preceding baseline of the trial, or 12 months if there is evidence of B cell return in peripheral lymphocyte subsets
Previous cyclophosphamide within 6 months preceding baseline of the trial
Parallel
Obinutuzumab Injection
DrugObinutuzumab (2-times, 1 g each) will be administered
Predniso(lo)ne
DrugPredniso(lo)ne will be used as the active comparator, with a planned withdrawal after 6 months
Non-inferiority of obinutuzumab to SoC predniso(lo)ne taper: Proportions of patients achieving remission (complete or partial) of MCD 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
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Medical University Innsbruck
Lead sponsor
Henri Mondor University Hospital
Collaborator
Centre Hospitalier Universitaire de Nice
Collaborator
Medical University of Graz
Collaborator
WiGeV Klinik Ottakring
Collaborator
Robert Bosch Medical Center
Collaborator
