Minimal Change Disease (MCD)Phase 2OBELIX-NSNCT07710157
A Trial to Assess the Efficacy and Safety of Obinutuzumab in Treating Adults With Minimal Change Disease (MCD)
A Phase 2 study testing Obinutuzumab Injection and Predniso(lo)ne in people with Minimal Change Disease (MCD), run by Medical University Innsbruck at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimal Change Disease (MCD)
- What is being tested?
- Obinutuzumab Injection and Predniso(lo)ne
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 13 Jul 2026to 30 Jun 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Philipp Gauckler, M.D. contact
6 sites in 3 countries
Austria3 sites, 3 recruiting
- Recruiting
Division of Nephrology, Department of Internal Medicine, Medical University of Graz
Graz, 8036
Max Schuller, M.D. Ph.D., 004331638512170, max.schuller@medunigraz.at
Kathrin Eller, M.D. Ph.D.
- Recruiting
Department of Internal Medicine IV, Nephrology and Hypertension
Innsbruck, 6020
Andreas Kronbichler, M.D. Ph.D., 004351250425855, andreas.kronbichler@i-med.ac.at
Philipp Gauckler, M.D., philipp.gauckler@i-med.ac.at
- Not yet recruiting
6. Medizinische Abteilung mit Nephrologie & Dialyse, Klinik Ottakring
Vienna, 1160
Sara Ksiazek, M.D., 00431491502610, sara.ksiazek@hotmail.com
Marcus Säemann, M.D.
France2 sites, 2 recruiting
- Not yet recruiting
Laboratory of Immunology, Nice University Hospital (CHU de Nice), Côte d'Azur University
Nice, 06003
Barbara Seitz-Polski, M.D. Ph.D., 0033492037917, seitz-polski.b@chu-nice.fr
Celine Fernandez, M.D., fernandez.c3@chu-nice.fr
- Not yet recruiting
Hôpital Henri-Mondor
Paris, 94000
Vincent Audard, M.D., 0033149812457, vincent.audard@aphp.fr
Germany1 site, 1 recruiting
- Not yet recruiting
Robert Bosch Krankenhaus, Department of General Internal Medicine and Nephrology
Stuttgart
Jörg Latus, M.D., +49 711 8101-3496, Joerg.Latus@rbk.de
Moritz Schanz, M.D.
About this study
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
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:
Read more
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
- Conditions
- Minimal Change Disease (MCD)
- Being tested
- Obinutuzumab Injection, Predniso(lo)ne
- Medical subject headings
- Nephrosis, Lipoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obinutuzumab InjectionDrug
Obinutuzumab (2-times, 1 g each) will be administered
Predniso(lo)neDrug
Predniso(lo)ne will be used as the active comparator, with a planned withdrawal after 6 months
| Study group | Role | What they receive |
|---|---|---|
| Obinutuzumab | Experimental | Not described Receives: Drug: Obinutuzumab Injection |
| Glucocorticoids | Active comparator | Not described Receives: Drug: Predniso(lo)ne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of obinutuzumab to SoC predniso(lo)ne taper: Proportions of patients achieving remission (complete or partial) of MCD at 8 weeks
Measured: 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
Measured: From enrollment to the end of treatment at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start13 Jul 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Change Disease (MCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Henri Mondor University Hospital, Centre Hospitalier Universitaire de Nice, Medical University of Graz, WiGeV Klinik Ottakring, Robert Bosch Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710157
- Sponsor's protocol ID
- 7174124
- Other IDs
- PIN7174124, 2025-520641-69, 2025
- Acronym
- OBELIX-NS
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No