Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-28 @ 6:35 AM
Study NCT ID:
NCT01602835
Status:
TERMINATED
Last Update Posted:
2014-02-11
First Post:
2012-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Urine Sample Collection for Alport Nephropathy Biomarker Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009394', 'term': 'Nephritis, Hereditary'}, {'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-10', 'studyFirstSubmitDate': '2012-05-17', 'studyFirstSubmitQcDate': '2012-05-18', 'lastUpdatePostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Alport syndrome', 'proteinuria', 'glomerular disease', 'hereditary nephropathy', 'nephropathy'], 'conditions': ['Alport Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a prospective cross-sectional, observational, single-center study of Alport patients, in which a single, first morning voided urine collection will be acquired and used to validate assays of urine biomarkers that reflect changes in glomerular protein filtration barrier function.\n\nThe purpose of this study is to identify biomarkers indicative of changes in glomerular filtration function that occur during the course of proteinuric renal diseases such as Alport nephropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with Alport syndrome identified by the Alport Syndrome Treatments and Outcome Registry (ASTOR)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Alport syndrome diagnosis (clinical and/or histopathologic and/or genetic diagnosis, per subject's physician and/or genotyping)\n* Physically able to provide a single first-morning urine sample of at least 30 mL\n\nExclusion criteria:\n\n* Diagnosis of chronic kidney disease\n* Receiving chronic phosphate-lowering therapy or erythropoietin therapy\n* Ongoing chronic hemodialysis therapy and/or renal transplant recipient\n* Nephrotic-range proteinuria: spot urine protein-to-creatinine ratio ≥ 3 on at least 2 of the last 3 clinical assessments Other protocol-defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT01602835', 'briefTitle': 'Human Urine Sample Collection for Alport Nephropathy Biomarker Studies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Human Urine Sample Collection for Alport Nephropathy Biomarker Studies', 'orgStudyIdInfo': {'id': 'CPLATFRM2201'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}