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

NCT06994468 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Flow-cytometry tetramer-based antigen-bait assay

For tetramer assembly, recombinant biotinylated PLA2R will be incubated with either streptavidin-PE (Agilent) or streptavidin-APC (Agilent) conjugates according to the NIH protocol (https://tetramer.yerkes.emory.edu/support/protocols#10). PBMCs will be thawed and resuspended in antibody cocktail medium containing 7.5ug APC- and PE- PLA2R tetramers. Multicolor flow cytometry will be used to identify B-cell subsets with standard technique and equipment (FACS FortessaX20, BD Biosciences and FlowJo software). PLA2R-specific B cells will be determined as Tetramer double (PE/APC) positive B cells that bind with proportional fluorescent intensities to each tetramer. Each sample will be incubated with only streptavidin-PE/APC conjugates to exclude B cells binding to the fluorochrome portion of the tetramers. T cell- and NK/NKT cell phenotyping will be assessed by FACS using ad-hoc antibody panels.

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Giuseppe Remuzzi, M.D. · Istituto Di Ricerche Farmacologiche Mario Negri

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-22
Primary Completion
2025-12-02
Completion
2025-12-02

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06994468 on ClinicalTrials.gov