Effect of B-cell Depleting Therapies on PLA2R-specific B Cells in Patients With Membranous Nephro… (NCT06994468) | Clinical Trial Compass
CompletedNot Applicable
Effect of B-cell Depleting Therapies on PLA2R-specific B Cells in Patients With Membranous Nephropathy
Italy48 participantsStarted 2025-09-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Patients
Inclusion Criteria:
* Patients enrolled in the ORION and MONET studies who have who provided written informed consent to store their samples collected during the follow-up at the Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò", Ranica (BG).
Exclusion Criteria:
* No written informed consent to store their samples collected during the follow-up at the Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò", Ranica (BG).
Volunteers
Inclusion criteria:
* Adult males and females.
* Written informed consent.
Exclusion criteria:
* History of renal diseases, autoimmune disorders, diabetes mellitus, current allergies.
* Subjects who have taken antibiotics, anti-inflammatory drugs, or antihistamines within the past 7 days.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Levels of circulating PLA2R-specific B cells
Timeframe: Levels measured at baseline and at 3, 6, 9, 12, 18, 24 months.
2
Levels of circulating PLA2R-specific B cells
Timeframe: Levels measured at baseline, 29, 141 days and at 6, 9, 12, 18, 24 months.
Trial details
NCT IDNCT06994468
SponsorMario Negri Institute for Pharmacological Research