Multitarget Strategy for Primary Podocytopathies

Not Applicable

Not yet recruiting

• Conditions: Nephrotic Syndrome

• Registration Number: NCT06718894
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2032-01
• Study Completion: 2032-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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	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.
Co-culture system reliability in case of podocytopathy remission	Baseline, 16 weeks and in case of remission/recurrence	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.

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy