Nephrotic Syndrome
Conditions
Keywords
podocytopathy, transplant
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).
Interventions
OTHERBiologic 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).
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Fondazione Regionale per la Ricerca Biomedica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Co-culture system capability to distinguish recurrent podocytopathies from healthy subjects | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Co-culture system reliability in case of podocytopathy remission | 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. |
Countries
Italy
Contacts
CONTACTManuel A Podesta', MD, PhD
CONTACTGiuseppe Castellano, MD, PhD
Outcome results
None listed