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| Name | Class |
|---|---|
| Fondazione Regionale per la Ricerca Biomedica | OTHER |
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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| In-vitro efficacy of SGLT2-inhibitors and uPAR/FPR-inhibitors on primary podocytopathies | Baseline, 16 weeks and in case of remission/recurrence | |
| Co-culture system capability to distinguish recurrent podocytopathies from other glomerular disorders | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Podocytopathy-specific proteomic and metabolomic profile in serum/plasma and urine | 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 |
Inclusion Criteria:
Signature of informed consent for study participation
One of the following conditions:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel A Podesta', MD, PhD | Contact | 0039 0255034568 | manuel.podesta@policlinico.mi.it | |
| Giuseppe Castellano, MD, PhD | Contact | giuseppe.castellano@policlinico.mi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
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| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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. | Baseline, 16 weeks and in case of remission/recurrence |
| Baseline, 16 weeks and in case of remission/recurrence |
| Podocytopathy-specific in vitro activation of immune subsets | Baseline, 16 weeks and in case of remission/recurrence |
| Podocytopathy-specific transcriptomic signatures of different immune cell subsets | Baseline, 16 weeks and in case of remission/recurrence |
| Podocytopathy-specific genomic differences in variants and SNPs associated with increased risk of disease | Baseline |
| Podocytopathy-specific proteomic and transcriptomic profile in kidney tissue | Baseline |
| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | Italy |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |