RecruitingNCT04095156

Autoreactive B Cells in Membranous Nephropathy

PLA2R Autoreactive B-Cell Subsets and Immune Cell Monitoring in Membranous Nephropathy: Identification of Outcome Predictors and Novel Insights Into Disease Pathogenesis


Sponsor

Mario Negri Institute for Pharmacological Research

Enrollment

86 participants

Start Date

Sep 25, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

Membranous nephropathy (MN) is the most frequent cause of nephrotic syndrome (NS) in adults. The majority of MN patients show detectable circulating antibodies against the M-type phospholipase A2 receptor (PLA2R). Infusion of anti-CD20 monoclonal antibodies results in a profound depletion of B-cells, which are thought to be responsible for anti-PLA2R production. B-cell depletion is followed by NS remission in 70% of cases. Limited evidence highlighted that differences in the B- and T-cell compartments may exist between responders and non-responders. Owing to the non-homogenous efficacy of anti-CD20 treatment, investigators hypothesize that in MN patients who experience NS remission after B-cell depleting therapy, autoreactive B-cells may be mostly circulating, whereas in patients who do not respond to the same treatment, autoreactive B-cells may chiefly reside into secondary lymphoid organs - and thus be more resistant to the drug action. Researchers will therefore extensively analyze the circulating immune repertoire of MN patients before and after the infusion of B-cell lineage depleting agents, assessing the presence of circulating PLA2R autoreactive B cells from appropriately stratified responder and non-responder patients. Patients and healthy controls will be enrolled in this study. Patients will be stratified according to gender, anti-PLA2R status, type of B-cell lineage depleting agent received and response to treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines the role of certain immune cells (autoreactive B cells) in membranous nephropathy — a kidney disease where the immune system mistakenly attacks the kidneys' filtering system. Researchers are studying patients who receive B cell-depleting therapy to better understand this disease. You may be eligible if (as a patient): - You are an adult (18+) with a kidney biopsy-proven diagnosis of idiopathic membranous nephropathy - You are scheduled to receive or have already received B cell-depleting treatment You may be eligible if (as a healthy volunteer): - You are 18 or older with no significant illness or regular medications You may NOT be eligible if: - Your membranous nephropathy has a known secondary cause (e.g., lupus, hepatitis B, cancer) - You have cognitive impairment or dementia that prevents giving informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTIn vitro assays.

Biochemical and flow-cytometry analysis of specimen collected.


Locations(1)

Centro di Ricerche Cliniche per le Malattie Rare " Aldo e Cele Daccò"

Ranica, BG, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04095156


Related Trials