CompletedNot Applicable

In Vitro Immunomodulation in Membranous Nephropathy Relapses

France20 participantsStarted 2022-05-23

Plain-language summary

In order to propose the best therapeutic option to relapsed MN patients with strong activation of the Th17 pathway, the investigators propose to study in vitro the effect of different immunomodulators on the Th17/Treg balance, assessed by cytokine profile and lymphocyte phenotyping using flow cytometry.

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.

Inclusion criteria

. Age ≥ 18 years
. Patient with MN proven on renal biopsy or by the presence of anti-PLA2R1 or anti-THDS71 antibodies
. Relapsed MN, defined as proteinuria \> 3.5g/g after achieving remission (partial or complete, definitions according to KDIGO 2012 guidelines)
. At a distance from any immunosuppressive treatment (at least 6 months)
. Freely given informed consent signed by the patient after clear, fair and appropriate information
. Affiliated to a social security system

Exclusion criteria

. Pregnant or breastfeeding woman
. Patient under 18 years of age
. Persons of legal age

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

Cytokine ELISA profiles of the Th17 pathway (IL-17 level), the Treg pathway (IL-10 level), the Th1 pathway (IL-12p70, IFN-γ) and the Th2 pathway (IL-4 and IL-5)

Timeframe: 18 months

Trial details

NCT IDNCT05428605

SponsorCentre Hospitalier Universitaire de Nice

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-30

View on ClinicalTrials.gov More Extramembranous Glomerulopathy trials