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

ClinicalTrials.gov ID

NCT07710157

Lead Sponsor

Medical University InnsbruckOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

48Estimated

Last Update Posted

Aug 17, 2026Actual

Start Date

Jul 13, 2026Actual

Primary Completion Date

Jun 30, 2028Estimated

Completion Date

Jun 30, 2029Estimated

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

Brief 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

• Minimal Change Disease (MCD)

• Obinutuzumab Injection
• Predniso(lo)ne

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Medical University InnsbruckOTHER

Collaborators

Henri Mondor University HospitalOTHER

Centre Hospitalier Universitaire de NiceOTHER

Medical University of GrazOTHER

WiGeV Klinik OttakringOTHER

Robert Bosch Medical CenterOTHER

vincent.audard@aphp.fr0033149812457

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