Multitarget approach for primary podocytopathies

Multitarget Strategy for Primary Podocytopathies

This project will test whether a lab cell culture can find a factor in the blood that causes proteinuria in people with primary podocytopathies and whether a combined therapy can block that factor in vitro.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sex: All
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (other)
• Locations: 2 sites (Milan and 1 other locations)
• Trial ID: NCT06718894 on ClinicalTrials.gov

What this trial studies

The trial uses a cell culture system to determine if patients' serum contains a circulating factor that injures podocytes and causes proteinuria. Samples from people with primary podocytopathies (FSGS or MCD) will be compared with samples from patients with other kidney diseases and healthy volunteers. The same cell system will be used to test the in vitro effectiveness of a combined therapeutic approach against any identified factor. Participants will provide blood and urine samples at regular visits for up to 36 months, and discarded plasmapheresis effluent will be collected if that procedure is performed.

Who should consider this trial

Good fit: Ideal participants are people diagnosed with primary podocytopathies (FSGS or MCD), including those with post-transplant recurrence, active native-kidney disease, or those undergoing plasmapheresis, alongside comparator groups with other renal diseases and healthy controls.

Not a fit: Patients in sustained clinical remission or whose kidney disease is clearly secondary to another cause and not driven by circulating factors may not receive direct benefit from participating.

Why it matters

Potential benefit: If successful, this work could produce a lab test to detect harmful circulating factors and guide treatments that prevent or reduce disease recurrence.

How similar studies have performed: Prior research supports the existence of circulating permeability factors and shows that plasmapheresis and some therapies can help certain patients, but clinically reliable cell-based assays to detect and guide therapy remain experimental.

Eligibility criteria

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

Where this trial is running

Milan and 1 other locations

• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (RECRUITING)
• Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (RECRUITING)

Study contacts

• Study coordinator: Manuel A Podesta', MD, PhD

Conditions: Nephrotic Syndrome, podocytopathy, transplant