CompletedNot Applicable

Immunophenotyping Profiling in Patients With Primary Nephrotic Syndrome

Greece40 participantsStarted 2023-06-01

Plain-language summary

Immunophenotyping profiling of patients with primary MN, primary FSGS and MCD. Evaluation of these immune cell subsets as possible biomarkers to track response to treatment or disease relapse.

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

. Patients with nephrotic syndrome and a biopsy-confirmed diagnosis of membranous nephropathy, primary focal segmental glomerulosclerosis, or minimal change disease.
. Patients with membranous nephropathy and positive serum anti-PLA2R antibodies, in the absence of histological confirmation by renal biopsy.
. Patients with a previously confirmed diagnosis of primary nephrotic syndrome who present with disease relapse requiring re-induction therapy.

Exclusion criteria

. Patients with nephrotic syndrome in whom membranous nephropathy, primary FSGS, or MCD has not been confirmed by renal biopsy (and who do not meet Inclusion Criterion 2).
. Patients with secondary causes of nephrotic syndrome (malignancy, autoimmune disease, drug-induced, etc.).
. Patients with active malignancy.
. Patients with severe heart failure (NYHA class IV) or hepatic failure.
. Patients with active infection or inflammation.
. Patients receiving, or who received within the preceding 6 months, immunomodulatory agents for an unrelated condition.

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

Partial Remission

Timeframe: 12 months

Complete Remission

Timeframe: 12 months

Relapse

Timeframe: 24 months

Trial details

NCT IDNCT07702981

SponsorUniversity Hospital, Ioannina

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-01

View on ClinicalTrials.gov More Membranous Nephropathy trials