Multitarget approach for primary podocytopathies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: manuel.podesta@policlinico.mi.it
• Phone: 0039 0255034568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.