Clinical Trial

Effect of B-cell Depleting Therapies on PLA2R-specific B Cells in Patients With Membranous Nephropathy

Study acronym: DEEPER
Completed
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Summary
This is a non-pharmacological interventional monocentric study to primarily assess the levels of circulating phospholipase A2 receptor (PLA2R)-specific B cells in patients with PLA2R-mediated MN enrolled in the ORION and MONET studies, before and at the different time points after therapy. It will also compare the phenotype of circulating PLA2R-specific B cell subsets over time in patients who achieved long-term remission, who experience MN relapses or did not respond to Obinutuzumab or Felzartamab therapies, and evaluate changes in lymphocyte subpopulations, including T cells and NK cells, possibly involved in the autoimmune process and in the response to B-cell depleting therapy.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-05-20; most recent amendment 2026-03-19.
Status change: Active, Not Recruiting → Completed 2026-03-19
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-08-27
Trial Details
NCT Number NCT06994468
Lead Sponsor Mario Negri Institute for Pharmacological Research
Conditions Membranous Nephropathy
Enrollment 48 participants
Start Date 2025-09-22
Primary Completion 2025-12-02 (estimated)
Study Completion 2025-12-02 (estimated)
Updated on ClinicalTrials.gov 2026-03-20