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

Recruiting Phase 2 Phase 3 Interventional Study
Membranous Nephropathy - PLA2R Induced
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Radboud University Medical Center · Other
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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…
Trial Locations
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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 s…
Contacts

Ruben Visch, M.D.

+31 (0)24 3092575

ruben.visch@radboudumc.nl

CONTACT

Anne-Els van de logt, M.D., PhD

+31611167560

anne-els.vandelogt@radboudumc.nl

CONTACT