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Research into the effect of Obinutuzumab on the level of PLA2R antibodies in patients with membranous nephropathy.
EU CTIS ID: 2025-521139-35-01
What this study is testing
To calculate the disappearance rate (half-life) of anti-PLA2R antibodies. Serum PLA2R antibodies will be measured at baseline, 1, 2, 4, 8, 12, 24 37 and 52 weeks after obinutuzumab infusions.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years.
- Diagnosis of primary membranous nephropathy, confirmed by: a) kidney biopsy or b) positive serum anti-PLA2R antibody test (either by IFT and/or ELISA).
- Serum anti-PLA2R antibody titer > 80 RU/ml.
- Proteinuria ≥ 3.5 g/24h despite supportive treatment for at least 6 months with maximally tolerated and stable dose of ACE-inhibitor or ARB.
- Serum albumin < 30 g/l measured by Bromocresol Purple (BCP) assay.
- eGFR ≥ 30 ml/min/1.73m2.
You likely can't join if
- Secondary membranous nephropathy (e.g., hepatitis B or C infection, human immunodeficiency virus infection, active infection, systemic lupus erythematosus, sarcoidosis, IgG4-related, drug-induced, malignancy).
- 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.
- Inability to understand or comply with the requirements of the study.
- Known active infection 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.
- Incapable of recognizing the nature, significance, and scope of the clinical trial or giving consent even with a legal representative.
See the full eligibility criteria
- Age ≥ 18 years.
- Diagnosis of primary membranous nephropathy, confirmed by: a) kidney biopsy or b) positive serum anti-PLA2R antibody test (either by IFT and/or ELISA).
- Serum anti-PLA2R antibody titer > 80 RU/ml.
- Proteinuria ≥ 3.5 g/24h despite supportive treatment for at least 6 months with maximally tolerated and stable dose of ACE-inhibitor or ARB.
- Serum albumin < 30 g/l measured by Bromocresol Purple (BCP) assay.
- eGFR ≥ 30 ml/min/1.73m2.
- Treatment with immunosuppression is warranted, as determined by the treating physician.
- Secondary membranous nephropathy (e.g., hepatitis B or C infection, human immunodeficiency virus infection, active infection, systemic lupus erythematosus, sarcoidosis, IgG4-related, drug-induced, malignancy).
- 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.
- Inability to understand or comply with the requirements of the study.
- Known active infection 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.
- 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.
- Rituximab within 12 months prior to inclusion.
- Calcineurin inhibitor 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 ACE-inhibitor/ARB.
- Life-threatening nephrotic syndrome resistant to treatment.
- > 20% increase in serum creatinine not otherwise explained.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.