ClinicalTrials.gg
RecruitingNCT07710157OBELIX-NSUpdated Aug 17, 2026

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

A Phase 2 interventional study of Obinutuzumab Injection and Predniso(lo)ne in Minimal Change Disease (MCD), sponsored by Medical University Innsbruck. Recruiting at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Medical University Innsbruck · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Minimal Change Disease (MCD)

Browse trials for

03

In context

Nephrosis, Lipoid

75 studies on the registry are indexed under Nephrosis, Lipoid; 32 are open to participants now.

This study's planned enrollment of 48 is close to the median of 49 across 46 interventional studies indexed under Nephrosis, Lipoid.

Browse Nephrosis, Lipoid studies →

Lead sponsor

Medical University Innsbruck is the lead sponsor of 186 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Understands and agrees to comply with the study procedures and provides 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. confirmed MCD (latest before randomization to Arm A or B)
  5. Only applies to women of (WOCBP):

    1. Has a high sensitivity negative urine/serum pregnancy test at screening
    2. Agrees to follow 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

Exclusion Criteria:

  1. MCD due to secondary causes, including 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 -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 , C or (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 ( 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 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. administration in the four weeks prior to screening and during the study duration of 52 weeks
  12. Previous/known to predniso(lo)ne or obinutuzumab or to any of the to be in accordance with the SmPC of Gazyvaro
  13. Co-enrolment in another clinical trial of an medicinal product
  14. Any other reason which, in the opinion of the Principal Investigator (PI), renders the patient unsuitable for the trial.
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Obinutuzumab

    Drug: Obinutuzumab Injection

  • Active comparator
    Glucocorticoids

    Drug: Predniso(lo)ne

Interventions

  • Obinutuzumab (2-times, 1 g each) will be administered

  • Predniso(lo)ne will be used as the active comparator, with a planned withdrawal after 6 months

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Study locations

2 of 6 sites recruiting
  • Division of Nephrology, Department of Internal Medicine, Medical University of Graz
    Graz, 8036, Austria
    Recruiting
  • Department of Internal Medicine IV, Nephrology and Hypertension
    Innsbruck, 6020, Austria
    Recruiting
  • 6. Medizinische Abteilung mit Nephrologie & Dialyse, Klinik Ottakring
    Vienna, 1160, Austria
    Not yet recruiting
  • Laboratory of Immunology, Nice University Hospital (CHU de Nice), Côte d'Azur University
    Nice, 06003, France
    Not yet recruiting
  • Hôpital Henri-Mondor
    Paris, 94000, France
    Not yet recruiting
  • Robert Bosch Krankenhaus, Department of General Internal Medicine and Nephrology
    Stuttgart, Germany
    Not yet recruiting
    • Jörg Latus, M.D. · ContactJoerg.Latus@rbk.de · +49 711 8101-3496
    • Moritz Schanz, M.D. · Contact
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Jun 2028, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2026
First posted
Jul 17, 2026
StartActual
Jul 13, 2026
Primary completionEst.
Jun 30, 2028
CompletionEst.
Jun 30, 2029
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07710157
Collaborators
Henri Mondor University Hospital, Centre Hospitalier Universitaire de Nice, Medical University of Graz, WiGeV Klinik Ottakring, Robert Bosch Medical Center
Responsible party
Sponsor
First posted
Jul 17, 2026
Start date
Jul 13, 2026
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Aug 17, 2026

Study contacts

Andreas Kronbichler, M.D. Ph.D.
Contact
andreas.kronbichler@i-med.ac.at
004351250425855
Philipp Gauckler, M.D.
Contact
philipp.gauckler@i-med.ac.at

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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