A Trial to Assess the Efficacy and Safety of Obinutuzumab in Treating Adults With Minimal Change … (NCT07710157) | Clinical Trial Compass
RecruitingPhase 2
A Trial to Assess the Efficacy and Safety of Obinutuzumab in Treating Adults With Minimal Change Disease (MCD)
Austria, France, Germany48 participantsStarted 2026-07-13
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Non-inferiority of obinutuzumab to SoC predniso(lo)ne taper: Proportions of patients achieving remission (complete or partial) of MCD at 8 weeks
Timeframe: 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
Timeframe: From enrollment to the end of treatment at 52 weeks
. Only applies to trial sites in France: Patients affiliated with the French health care system
Exclusion criteria
. 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)