Actively Recruiting
PLA2R Autoreactive B-Cell Subsets and Immune Cell Monitoring in Membranous Nephropathy Identification of Outcome Predictors and Novel Insights Into Disease Pathogenesis
Led by Mario Negri Institute for Pharmacological Research · Updated on 2026-03-20
86
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating membranous nephropathy (MN), a common cause of nephrotic syndrome in adults, focusing on the role of autoreactive B cells that produce antibodies against the PLA2R receptor. The study aims to understand why some patients respond to B-cell depleting treatments while others do not, by comparing circulating immune cells in responders, non-responders, and healthy controls. This observational study will help identify differences in immune cell behavior related to treatment outcomes. The study includes patients with biopsy-confirmed idiopathic MN who are either planned to receive or have already received B-cell depleting therapy, as well as healthy volunteers without significant illnesses. Researchers will analyze blood samples using biochemical and flow cytometry assays to measure the frequency and activity of various B-cell subsets and other immune cells over a 24-month period. This includes assessments at baseline and multiple follow-up points at 3, 6, 9, 12, and 24 months. Participants will provide blood specimens that will be tested to evaluate the presence and function of autoreactive B cells and other immune cell types. The study will track changes in these immune cells over time, correlating findings with treatment response. The research involves no interventional treatments but focuses on extensive immune monitoring to better understand MN disease mechanisms and predict outcomes. Participation duration varies, with multiple follow-up visits for sample collection and immune profiling.
CONDITIONS
Brief Title
Autoreactive B Cells in Membranous Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults older than 18 years
- Patients with biopsy-proven idiopathic membranous nephropathy who are candidates to receive or have received B-cell depleting treatment
- Healthy volunteers older than 18 years without significant illness
- Healthy volunteers not regularly taking any medication or drugs
- Ability to understand the study and provide written informed consent according to the Declaration of Helsinki
You will not qualify if you...
- Patients with possible secondary causes of membranous nephropathy such as systemic lupus erythematosus, active hepatitis B, malignancy, or use of certain drugs like gold salts and penicillamine
- Legal incapacity, intellectual disability, dementia, uncooperative behavior, or inability to understand study procedures and provide consent
- Healthy volunteers with legal incapacity, intellectual disability, dementia, uncooperative behavior, or inability to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants provide blood samples for biochemical and flow-cytometry analysis to assess circulating B-cell subsets and immune cells.
Visits at baseline and at 3, 6, 9, 12, and 24 months
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
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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