Multitarget Strategy for Primary Podocytopathies

ConditionNephrotic Syndrome

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Signature of informed consent for study participation

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Biologic fluid sampling
Other intervention
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).

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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

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.

Time frame

Baseline

Secondary outcomes

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

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.

Time frame

Baseline, 16 weeks and in case of remission/recurrence

Other outcomes

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

Time frame

Baseline, 16 weeks and in case of remission/recurrence

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

Podocytopathy-specific in vitro activation of immune subsets

Time frame

Baseline, 16 weeks and in case of remission/recurrence

Podocytopathy-specific transcriptomic signatures of different immune cell subsets

Time frame

Baseline, 16 weeks and in case of remission/recurrence

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Lead sponsor

Fondazione Regionale per la Ricerca Biomedica

Collaborator

Source ClinicalTrials.gov

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