Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-28 @ 9:43 PM
Study NCT ID:
NCT06718894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-05
First Post:
2024-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multitarget Strategy for Primary Podocytopathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009404', 'term': 'Nephrotic Syndrome'}], 'ancestors': [{'id': 'D009401', 'term': 'Nephrosis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2032-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'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'}], 'primaryOutcomes': [{'measure': 'Co-culture system capability to distinguish recurrent podocytopathies from healthy subjects', 'timeFrame': 'Baseline', 'description': '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.'}], 'secondaryOutcomes': [{'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', 'description': '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': 'Co-culture system reliability in case of podocytopathy remission', 'timeFrame': 'Baseline, 16 weeks and in case of remission/recurrence', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['podocytopathy', 'transplant'], 'conditions': ['Nephrotic Syndrome']}, 'descriptionModule': {'briefSummary': '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.\n\nResearchers will compare samples from patients with primary podocytopathies with those obtained from healthy subjects and patients with other renal disorders.\n\nParticipants 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signature of informed consent for study participation\n* One of the following conditions:\n\n 1. Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) showing clinical and/or histological evidence of post-transplant recurrence.\n 2. Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) without clinical and/or histological evidence of post-transplant recurrence.\n 3. Patients with primary podocytopathies in their native kidneys in an active clinical phase of the disease.\n 4. Patients with podocytopathies presenting clinical features compatible with a secondary form due to another condition.\n 5. Patients with glomerulonephritis other than primary podocytopathies (e.g., IgA nephropathy, systemic lupus erythematosus, membranous nephropathy).\n 6. Patients with no history of renal diseases\n\nExclusion Criteria:\n\n* Subjects affected by primary podocytopathies or other glomerulonephritides in clinical remission or with ESRD (eGFR \\< 15 ml/min) and/or on renal replacement therapy\n* Individuals unable to understand and consent to the study procedures\n* Any clinical condition that, according to the investigator's judgment, could compromise patient safety during study participation"}, 'identificationModule': {'nctId': 'NCT06718894', 'acronym': 'PODO-TARGET', 'briefTitle': 'Multitarget Strategy for Primary Podocytopathies', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Multitarget Strategy for Primary Podocytopathies', 'orgStudyIdInfo': {'id': '5387'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Biologic fluid sampling', 'type': 'OTHER', 'description': '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).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': "Manuel A Podesta', MD, PhD", 'role': 'CONTACT', 'email': 'manuel.podesta@policlinico.mi.it', 'phone': '0039 0255034568'}, {'name': 'Giuseppe Castellano, MD, PhD', 'role': 'CONTACT', 'email': 'giuseppe.castellano@policlinico.mi.it'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione Regionale per la Ricerca Biomedica', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}