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Recruiting NCT06718894

Multitarget Strategy for Primary Podocytopathies

No phase Interventional Nephrotic Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biologic fluid sampling.
Who it may be relevant to
Registry conditions: Nephrotic Syndrome. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Other Biologic fluid sampling
    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 outcome measures

  • Co-culture system capability to distinguish recurrent podocytopathies from healthy subjects [Time frame: Baseline]
Secondary outcome measures (3)
  • In-vitro efficacy of SGLT2-inhibitors and uPAR/FPR-inhibitors on primary podocytopathies [Time frame: Baseline, 16 weeks and in case of remission/recurrence]
  • Co-culture system capability to distinguish recurrent podocytopathies from other glomerular disorders [Time frame: Baseline]
  • Co-culture system reliability in case of podocytopathy remission [Time frame: Baseline, 16 weeks and in case of remission/recurrence]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Italy · 2 centers
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan
  • Fondazione IRCCS Policlinico San Matteo — Pavia

Identifiers

NCT: NCT06718894 · 5387

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗