Clinical trial NCT06718894: Multitarget Strategy for Primary Podocytopathies
Official title: Multitarget Strategy for Primary Podocytopathies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nephrotic Syndrome
Keywords: podocytopathy
transplant
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: Fondazione Regionale per la Ricerca Biomedica
First posted: 2024-12-05
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


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

Primary outcomes:
measure: Co-culture system capability to distinguish recurrent podocytopathies from healthy subjects
timeFrame: Baseline
Secondary outcomes:
measure: In-vitro efficacy of SGLT2-inhibitors and uPAR/FPR-inhibitors on primary podocytopathies
timeFrame: Baseline, 16 weeks and in case of remission/recurrence
measure: Co-culture system capability to distinguish recurrent podocytopathies from other glomerular disorders
timeFrame: Baseline
measure: Co-culture system reliability in case of podocytopathy remission
timeFrame: Baseline, 16 weeks and in case of remission/recurrence
Other outcomes:
measure: Podocytopathy-specific proteomic and metabolomic profile in serum/plasma and urine
timeFrame: Baseline, 16 weeks and in case of remission/recurrence
measure: Podocytopathy-specific proteomic and metabolomic profile of endothelial cells and podocytes exposed to serum from patients with podocytopathies
timeFrame: Baseline, 16 weeks and in case of remission/recurrence
measure: Podocytopathy-specific in vitro activation of immune subsets
timeFrame: Baseline, 16 weeks and in case of remission/recurrence
measure: Podocytopathy-specific transcriptomic signatures of different immune cell subsets
timeFrame: Baseline, 16 weeks and in case of remission/recurrence
measure: Podocytopathy-specific genomic differences in variants and SNPs associated with increased risk of disease
timeFrame: Baseline
measure: Podocytopathy-specific proteomic and transcriptomic profile in kidney tissue
timeFrame: Baseline
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
References: