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

Official title

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

Overview

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

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

Primary outcome measures

• Non-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]

Eligibility criteria

Inclusion criteria

• 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)
• Only applies to women of childbearing potential (WOCBP):

• Has a high sensitivity negative urine/serum pregnancy test at screening
• Agrees to follow contraceptive guidance until 18 months after 2nd obinutuzumab treatment (if randomized to Arm B)
• Only applies to trial sites in France: Patients affiliated with the French health care system

Exclusion criteria

• 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
• Treatment with Predniso(lo)ne within screening phase (before randomization)
• Evidence of current or past infection with Hepatitis B, C or Human Immunodeficiency Virus (HIV) (unless appropriate prophylaxis is given and no replicating virus is detected)
• Evidence of active severe infection requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to first dose of study drug
• Severe heart failure or severe, uncontrolled cardiac disease (NYHA class III or IV)
• Patient with a history of prior malignancy within 5 years before the first dose of study drug. Exceptions may apply for the following: malignancies with a negligible risk of metastasis or death such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer
• Pregnant or breast-feeding women
• Live vaccine administration in the four weeks prior to screening and during the study duration of 52 weeks
• Previous/known hypersensitivity to predniso(lo)ne or obinutuzumab or to any of the excipients to be in accordance with the SmPC of Gazyvaro
• Co-enrolment in another clinical trial of an investigational medicinal product
• Any other reason which, in the opinion of the Principal Investigator (PI), renders the patient unsuitable for the trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Austria · 3 centers

• Division of Nephrology, Department of Internal Medicine, Medical University of Graz — Graz
• Department of Internal Medicine IV, Nephrology and Hypertension — Innsbruck
• 6. Medizinische Abteilung mit Nephrologie & Dialyse, Klinik Ottakring — Vienna

France · 2 centers

• Laboratory of Immunology, Nice University Hospital (CHU de Nice), Côte d'Azur University — Nice
• Hôpital Henri-Mondor — Paris

Germany · 1 center

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

Identifiers

NCT: NCT07710157 · 7174124 · PIN7174124 · 2025-520641-69

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗