Actively Recruiting
Autoreactive B Cells in Membranous Nephropathy
Led by Mario Negri Institute for Pharmacological Research · Updated on 2026-03-20
86
Participants Needed
1
Research Sites
370 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Autoreactive B Cells in Membranous Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults over 18 years old
- Patients with biopsy-proven idiopathic membranous nephropathy who are candidates for or have received B-cell depleting treatment
- Mental ability to understand and give valid consent
- Written informed consent according to the Declaration of Helsinki
- Healthy volunteers over 18 years old without significant illness
- Healthy volunteers not taking regular medications
- Healthy volunteers with negative urine analysis
- Written informed consent for healthy volunteers according to the Declaration of Helsinki
You will not qualify if you...
- Possibility of secondary causes of membranous nephropathy such as systemic lupus erythematosus, active hepatitis B, malignancy, or certain drugs
- Legal incapacity, intellectual disability, dementia, uncooperative attitude, or inability to give informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centro di Ricerche Cliniche per le Malattie Rare " Aldo e Cele Daccò"
Ranica, BG, Italy, 24020
Actively Recruiting
Research Team
M
Manuel Podestà, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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