New drug aims to silence harmful antibodies in kidney disease
NCT ID NCT07163611
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called obinutuzumab in 20 adults with a high-risk form of membranous nephropathy, a kidney disease caused by antibodies attacking the kidneys. The goal is to see how quickly the drug lowers those harmful antibodies and whether it leads to remission. Participants receive two infusions initially, with possible extra doses after six months if needed, and are followed for a year.
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 point toward a more effective treatment for high-risk membranous nephropathy, potentially leading to disease remission and preserved kidney function.
- What could go wrong
- This is a small, early pilot study with only 20 participants, so results may not apply to everyone. The drug may cause side effects, and not all patients may achieve remission.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Apr 2028
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: * Age ≥ 18 years. * Diagnosis of PMN, confirmed by: 1. Kidney biopsy or 2. Positive serum PLA2Rab test either by IFT and/or ELISA) * Serum PLA2Rab titer \> 80 RU/ml * Proteinuria ≥ 3.5 g/24h despite supportive treatment for at least 6 months with a maximally tolerated and stable dose of ACE-i or ARB. * Serum albumin \< 30 g/l measured by BCP assay. * eGFR ≥ 30 ml/min/1.73m2. * Treatment with immunosuppression is warranted, as determined by the treating physician. Exclusion Criteria: * Secondary MN (e.g., hepatitis B or C infection, human immunodeficiency virus infection, active infection, systemic lupus erythematosus, sarcoidosis, IgG4-related, drug-induced, malignancy). * RTX within 12 months prior to inclusion. * CNI within 2 months prior to inclusion. * Treatment with other immunosuppressive drugs within 6 months prior to inclusion. * Proteinuria must not have decreased by \> 50% over 6 months whilst taking ACEi/ARB. * Life-threatening nephrotic syndrome resistant to treatment. * \> 20% increase in serum creatinine not otherwise explained during antiproteinuric supportive treatment. * Pregnancy or breastfeeding. Women of childbearing age and male patients with female partners of childbearing potential not willing to use contraception throughout the study and for at least 6 months after the last dose of obinutuzumab. * Suspected or known hypersensitivity, allergy, and/or immunogenic reaction history to monoclonal antibodies, corticosteroid, cyclophosphamide, any of their ingredients, and any other drugs from these same pharmacotherapeutic groups. * Known active infection of any kind or recent major episode of infection. * Any disorder or condition which might pose an unacceptable risk to patient's safety and well-being that might interfere with completion of the study. * Inability to understand or comply with the requirements of the study. * Incapable of recognizing the nature, significance, and scope of the clinical trial or giving consent even with a legal representative. * Use of an investigational agent.
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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
1 site. 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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Department of Nephrology, Radboud University Medical Center
RECRUITINGNijmegen, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody drug zuberitamab takes aim at kidney disease in phase 3 trial
- Kidney disease drug may train immune cells to calm themselves
- A new tool to predict kidney failure risk in membranous nephropathy?
- Can engineered immune cells tackle a tough kidney disease?
- Can a smarter antibody outsmart a kidney disease that resists standard treatment?
- Can engineered immune cells tame autoimmune kidney disease?