Could a targeted antibody outdo steroids for a rare kidney disease?
NCT ID NCT07710157
First seen Jul 17, 2026 · Last updated Aug 18, 2026 · Updated 5 times
Summary
This phase IIa trial investigates whether obinutuzumab, a monoclonal antibody, can effectively treat adults with newly diagnosed minimal change disease, a kidney condition causing protein leakage and swelling. Participants receive either two doses of obinutuzumab or standard glucocorticoid therapy, with the goal of inducing remission and preventing relapses over 52 weeks. The study compares the two treatments for safety and effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- obinutuzumab, a monoclonal antibody drug
- What this could lead to
- If successful, this could offer a new treatment option for adults with minimal change disease, potentially reducing relapses compared to standard steroids.
- What could go wrong
- This is an early-phase trial with only 48 participants, so results may not be conclusive. Obinutuzumab may cause side effects like infusion reactions or infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Understands and agrees to comply with the study procedures and provides informed consent 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. Histologically confirmed MCD (latest before randomization to Arm A or B) 5. Only applies to women of childbearing potential (WOCBP): 1. Has a high sensitivity negative urine/serum pregnancy test at screening 2. Agrees to follow contraceptive 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: 1. 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) 2. Family history of MCD or in a first degree relative unless previously shown to be steroid-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 Hepatitis B, C or Human Immunodeficiency Virus (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 (NYHA 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 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 10. Pregnant or breast-feeding women 11. Live vaccine administration in the four weeks prior to screening and during the study duration of 52 weeks 12. Previous/known hypersensitivity to predniso(lo)ne or obinutuzumab or to any of the excipients to be in accordance with the SmPC of Gazyvaro 13. Co-enrolment in another clinical trial of an investigational medicinal product 14. Any other reason which, in the opinion of the Principal Investigator (PI), renders the patient unsuitable for the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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6. Medizinische Abteilung mit Nephrologie & Dialyse, Klinik Ottakring
NOT_YET_RECRUITINGVienna, 1160, Austria
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Department of Internal Medicine IV, Nephrology and Hypertension
RECRUITINGInnsbruck, 6020, Austria
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Division of Nephrology, Department of Internal Medicine, Medical University of Graz
RECRUITINGGraz, 8036, Austria
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Hôpital Henri-Mondor
NOT_YET_RECRUITINGParis, 94000, France
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Laboratory of Immunology, Nice University Hospital (CHU de Nice), Côte d'Azur University
NOT_YET_RECRUITINGNice, 06003, France
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Robert Bosch Krankenhaus, Department of General Internal Medicine and Nephrology
NOT_YET_RECRUITINGStuttgart, Germany
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