Multitarget Strategy for Primary Podocytopathies

NCT06718894 | Recruiting

• 1 other identifier: 5387
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Nephrotic Syndrome

Keywords

podocytopathy; transplant

Outcome Measures

Primary Outcomes (1)

• Co-culture system capability to distinguish recurrent podocytopathies from healthy subjects

  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.

  Baseline

Secondary Outcomes (3)

• In-vitro efficacy of SGLT2-inhibitors and uPAR/FPR-inhibitors on primary podocytopathies

  Baseline, 16 weeks and in case of remission/recurrence

• Co-culture system capability to distinguish recurrent podocytopathies from other glomerular disorders

  Baseline

• Co-culture system reliability in case of podocytopathy remission

  Baseline, 16 weeks and in case of remission/recurrence

Other Outcomes (6)

• Podocytopathy-specific proteomic and metabolomic profile in serum/plasma and urine

  Baseline, 16 weeks and in case of remission/recurrence

• Podocytopathy-specific proteomic and metabolomic profile of endothelial cells and podocytes exposed to serum from patients with podocytopathies

  Baseline, 16 weeks and in case of remission/recurrence

• Podocytopathy-specific in vitro activation of immune subsets

  Baseline, 16 weeks and in case of remission/recurrence

Interventions

Biologic fluid sampling OTHER

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signature of informed consent for study participation
• One of the following conditions:
• Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) showing clinical and/or histological evidence of post-transplant recurrence.
• Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) without clinical and/or histological evidence of post-transplant recurrence.
• Patients with primary podocytopathies in their native kidneys in an active clinical phase of the disease.
• Patients with podocytopathies presenting clinical features compatible with a secondary form due to another condition.
• Patients with glomerulonephritis other than primary podocytopathies (e.g., IgA nephropathy, systemic lupus erythematosus, membranous nephropathy).
• Patients with no history of renal diseases

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Regionale per la Ricerca Biomedica: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (2)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

RECRUITING

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Manuel A Podesta', MD, PhD

CONTACT

0039 0255034568; manuel.podesta@policlinico.mi.it

Giuseppe Castellano, MD, PhD

CONTACT

giuseppe.castellano@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: June 19, 2025
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): November 1, 2032
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

IT (2)