💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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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