NCT07710157

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
35mo left

Started Jul 2026

Typical duration for phase_2

Geographic Reach
3 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Jun 2029

First Submitted

Initial submission to the registry

July 13, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 13, 2026

Last Update Submit

July 20, 2026

Conditions

Minimal Change Disease (MCD)

Outcome Measures

Primary Outcomes (2)

  • Non-inferiority of obinutuzumab to SoC predniso(lo)ne taper: Proportions of patients achieving remission (complete or partial) of MCD at 8 weeks

    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

    From enrollment to the end of treatment at 52 weeks

Study Arms (2)

Obinutuzumab

EXPERIMENTAL
Drug: Obinutuzumab Injection

Glucocorticoids

ACTIVE COMPARATOR
Drug: Predniso(lo)ne

Interventions

Predniso(lo)neDRUG

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

Glucocorticoids
Obinutuzumab InjectionDRUG

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

Obinutuzumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Division of Nephrology, Department of Internal Medicine, Medical University of Graz

Graz, 8036, Austria

NOT YET 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

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

Hamburg, Germany

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Nephrosis, Lipoid

Interventions

obinutuzumab

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Andreas Kronbichler, M.D. Ph.D.

CONTACT

004351250425855andreas.kronbichler@i-med.ac.at

Philipp Gauckler, M.D.

CONTACT

philipp.gauckler@i-med.ac.at

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2026

First Posted

July 17, 2026

Study Start

July 13, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

July 21, 2026

Record last verified: 2026-07

Locations

FR(2)DE(1)AU(3)