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

NCT07710157 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-08-17

No results posted yet for this 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

Conditions

  • Minimal Change Disease (MCD)

Interventions

DRUG

Obinutuzumab Injection

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

DRUG

Predniso(lo)ne

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

Sponsors & Collaborators

  • Henri Mondor University Hospital

    collaborator OTHER

  • Centre Hospitalier Universitaire de Nice

    collaborator OTHER

  • Medical University of Graz

    collaborator OTHER

  • WiGeV Klinik Ottakring

    collaborator OTHER

  • Robert Bosch Medical Center

    collaborator OTHER

  • Medical University Innsbruck

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-13
Primary Completion
2028-06-30
Completion
2029-06-30

Countries

  • Austria
  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07710157 on ClinicalTrials.gov