Obinutuzumab vs steroids for adults with minimal change disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial compares obinutuzumab to glucocorticoids in adults with first-episode nephrotic syndrome due to de novo minimal change disease. Participants receive two doses of obinutuzumab or standard prednisone-based therapy and are followed for 52 weeks with regular clinic visits; additional follow-up occurs if relapse happens. The trial aims to determine non-inferiority in initial remission and potential superiority in relapse-free survival, while monitoring safety and baseline phenotyping of the disease. Study sites are in France and Austria, involving multiple nephrology centers. Primary questions focus on efficacy, safety, and deeper characterization of patient subtypes within MCD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Understands and agrees to comply with the study procedures and provides informed consent as documented by signature
2. Male or female patients aged 18 years or older at the time of consent
3. 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
4. Histologically confirmed MCD (latest before randomization to Arm A or B)
5. Only applies to women of childbearing potential (WOCBP):

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

Exclusion Criteria:

1. 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)
2. Family history of MCD or in a first degree relative unless previously shown to be steroid-responsive
3. 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
4. Previous cyclophosphamide within 6 months preceding baseline of the trial
5. Treatment with Predniso(lo)ne within screening phase (before randomization)
6. 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)
7. Evidence of active severe infection requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to first dose of study drug
8. Severe heart failure or severe, uncontrolled cardiac disease (NYHA class III or IV)
9. 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
10. Pregnant or breast-feeding women
11. Live vaccine administration in the four weeks prior to screening and during the study duration of 52 weeks
12. Previous/known hypersensitivity to predniso(lo)ne or obinutuzumab or to any of the excipients to be in accordance with the SmPC of Gazyvaro
13. Co-enrolment in another clinical trial of an investigational medicinal product
14. Any other reason which, in the opinion of the Principal Investigator (PI), renders the patient unsuitable for the trial.

Where it's running

• Division of Nephrology, Department of Internal Medicine, Medical University of Graz
  Graz, Austria Recruiting
• Department of Internal Medicine IV, Nephrology and Hypertension
  Innsbruck, Austria Recruiting
• 6. Medizinische Abteilung mit Nephrologie & Dialyse, Klinik Ottakring
  Vienna, Austria Not yet recruiting
• Laboratory of Immunology, Nice University Hospital (CHU de Nice), Côte d'Azur University
  Nice, France Not yet recruiting
• Hôpital Henri-Mondor
  Paris, France Not yet recruiting
• Robert Bosch Krankenhaus, Department of General Internal Medicine and Nephrology
  Stuttgart, Germany Not yet recruiting

Study contacts

• Study coordinator: Andreas Kronbichler, M.D. Ph.D.
• Email: andreas.kronbichler@i-med.ac.at
• Phone: 004351250425855

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.