Multitarget Strategy for Primary Podocytopathies

NCT06718894 · tracked via the Priya Life Science Italy tracker

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Phase

Not applicable

Started

2025-06-19

Last updated

2026-03-27

Condition(s) studied

Nephrotic Syndrome

Investigational drug(s) / intervention(s)

Biologic fluid sampling

Biologic fluid sampling: The only interventions in addition to standard clinical practice will be blood sampling, the collection of morning spot urine and the collection of the discarded effluent of the plasmapheresis procedure (when performed according to clinical indication).

Study summary

The goal of this clinical trial is to verify whether a cell culture system can be used to evaluate the presence of a factor capable of causing proteinuria in the serum of patients with primary podocytopathies. This system will also be used to evaluate the in vitro efficacy of a combined therapy for the treatment of this disorder.

Researchers will compare samples from patients with primary podocytopathies with those obtained from healthy subjects and patients with other renal disorders.

Participants will be asked to visit the clinic at regular intervals for up to 36 months, and to provide blood and urine samples (and a sample of the discarded plasmapheresis effluent in case the procedure is performed).

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * Signature of informed consent for study participation * One of the following conditions: 1. Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) showing clinical and/or histological evidence of post-transplant recurrence. 2. Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) without clinical and/or histological evidence of post-transplant recurrence. 3. Patients with primary podocytopathies in their native kidneys in an active clinical phase of the disease. 4. Patients with podocytopathies presenting clinical features compatible with a secondary form due to another condition. 5. Patients with glomerulonephritis other than primary podocytopathies (e.g., IgA nephropathy, systemic lupus erythematosus, membranous nephropathy). 6. Patients with no history of renal diseases Exclusion Criteria: * Subjects affected by primary podocytopathies or other glomerulonephritides in clinical remission or with ESRD (eGFR \< 15 ml/min) and/or on renal replacement therapy * Individuals unable to understand and consent to the study procedures * Any clinical condition that, according to the investigator's judgment, could compromise patient safety during study participation

Primary outcome measure(s)

Co-culture system capability to distinguish recurrent podocytopathies from healthy subjects — Baseline
The difference in the increase of albumin permeability in the endothelium-podocyte co-culture system after exposure to serum from patients with recurrent podocytopathies and healthy subjects will be compared.

Trial sites (2)

Facility	City	Region	Status
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan	Italy	Recruiting
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06718894 on ClinicalTrials.gov ↗ ← All trials in Italy