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Obinutuzumab Induced Decreases of PLA2R Antibodies in Membranous Nephropathy: a Pilot Study

RecruitingPhase 2, Phase 3

Sponsor: Radboud University Medical Center

Conditions: Membranous Nephropathy - PLA2R Induced

Interventions: Obinutuzumab administration

Countries: Netherlands

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Nijmegen, Netherlands