Multitarget Strategy for Primary Podocytopathies (PODO-TARGET)

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).

Study Overview

• Status: Recruiting
• Conditions: Nephrotic Syndrome
• Intervention / Treatment: Other: Biologic fluid sampling

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel A Podesta', MD, PhD; Phone Number: 0039 0255034568; Email: manuel.podesta@policlinico.mi.it
• Study Contact Backup: Name: Giuseppe Castellano, MD, PhD; Email: giuseppe.castellano@policlinico.mi.it

Study Locations

• Italy
  • Milan, Italy, 20122
    • Recruiting
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    • Contact: Manuel A Podestà, MD, PhD; Phone Number: 00390255034552; Email: nefrologia@policlinico.mi.it
  • Pavia, Italy
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo
    • Contact: Teresa Rampino, MD; Phone Number: 00390382502591

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 patients with other glomerular disorders will be compared.	Baseline
Co-culture system reliability in case of podocytopathy remission	The difference in the increase of albumin permeability in the endothelium-podocyte co-culture system after exposure to serum from patients with active podocytopathies and podocytopathies in the remission phase will be compared.	Baseline, 16 weeks and in case of remission/recurrence

Other Outcome Measures

Outcome Measure	Time Frame
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
Podocytopathy-specific transcriptomic signatures of different immune cell subsets	Baseline, 16 weeks and in case of remission/recurrence
Podocytopathy-specific genomic differences in variants and SNPs associated with increased risk of disease	Baseline
Podocytopathy-specific proteomic and transcriptomic profile in kidney tissue	Baseline

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2025
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): November 1, 2032

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: transplant; podocytopathy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Nephrosis; Nephrotic Syndrome
• Other Study ID Numbers: 5387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No