Obinutuzumab Induced Decreases of PLA2R Antibodies in Membranous Nephropathy: a Pilot Study
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
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
Qualifiers
Age ≥ 18 years.
Kidney biopsy or
Positive serum PLA2Rab test either by IFT and/or ELISA)
Serum PLA2Rab titer > 80 RU/ml
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Obinutuzumab administration
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Radboud University Medical Center
Lead sponsor
Hoffmann-La Roche
Collaborator
Source ClinicalTrials.gov