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.
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…
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