NCT07163611 Obinutuzumab Induced Decreases of PLA2R Antibodies in Membranous Nephropathy: a Pilot Study
| NCT ID | NCT07163611 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Radboud University Medical Center |
| Condition | Membranous Nephropathy - PLA2R Induced |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-10-01 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Objective: To assess the disappearance rate (half-life) of anti-PLA2R antibodies in high-risk primary membranous nephropathy (pMN) patients treated with obinutuzumab (OBI), and to evaluate immunological and clinical remission, adverse events, and quality of life. Design: Open-label, single-center, prospective pilot intervention study conducted at Radboud University Medical Center. Population: 20 adult patients with high-risk PMN, defined by proteinuria ≥3.5 g/24h despite 6 months of supportive treatment with ACE inhibitors or ARBs. Intervention: OBI 1000 mg on days 1 and 15, with two additional infusions after 6 months if anti-PLA2R antibody levels remain positive and proteinuria exceeds 2 g/24h. Follow-up: Patients were monitored at baseline, and at weeks 1, 2, 4, 8, 12, 24, 37, and 52.
Eligibility Criteria
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.
Contact & Investigator
Anne-Els Van de Logt, M.D., PhD
PRINCIPAL INVESTIGATOR
Radboud University Medical Center
Frequently Asked Questions
Who can join the NCT07163611 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Membranous Nephropathy - PLA2R Induced. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07163611 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07163611 currently recruiting?
Yes, NCT07163611 is actively recruiting participants. Contact the research team at ruben.visch@radboudumc.nl for enrollment information.
Where is the NCT07163611 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT07163611 clinical trial?
NCT07163611 is sponsored by Radboud University Medical Center. The principal investigator is Anne-Els Van de Logt, M.D., PhD at Radboud University Medical Center. The trial plans to enroll 20 participants.