Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06718894

Multitarget Strategy for Primary Podocytopathies

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Nephrotic Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: Baseline, 16 weeks and in case of remission/recurrence

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

    Time frame: 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.

  3. Co-culture system reliability in case of podocytopathy remission

    Time frame: 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.

Other outcomes

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

    Time frame: Baseline, 16 weeks and in case of remission/recurrence

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

    Time frame: Baseline, 16 weeks and in case of remission/recurrence

  3. Podocytopathy-specific in vitro activation of immune subsets

    Time frame: Baseline, 16 weeks and in case of remission/recurrence

  4. Podocytopathy-specific transcriptomic signatures of different immune cell subsets

    Time frame: Baseline, 16 weeks and in case of remission/recurrence

  5. Podocytopathy-specific genomic differences in variants and SNPs associated with increased risk of disease

    Time frame: Baseline

  6. Podocytopathy-specific proteomic and transcriptomic profile in kidney tissue

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Castellano, MD, PhD

CONTACT

[email protected]

Manuel A Podesta', MD, PhD

CONTACT

[email protected]

0039 0255034568

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Collaborators

  • Fondazione Regionale per la Ricerca Biomedica

Registry information

Acronym: PODO-TARGET

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Dec 5, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.