Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT06036758
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2023-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VIDAS® NEPHROCLEAR Diagnostic Accuracy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 477}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2023-09-07', 'studyFirstSubmitQcDate': '2023-09-07', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of developing persistent severe AKI', 'timeFrame': 'Within 48 hours of ICU admittance', 'description': 'The urine sample collected from ICU patients will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test, which is intended to be used in conjunction with clinical evaluation, in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI), as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Kidney Injury', 'Stage 2 Acute Kidney Injury', 'Stage 3 Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'This is a multi-center sample analysis study in which urine samples previously collected from persons with Stage 2 or Stage 3 Acute Kidney Injury (AKI), will be tested in order to validate the VIDAS® NEPHROCLEAR™ CCL14 Test', 'detailedDescription': 'The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in conjunction with clinical evaluation, in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI), as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment.\n\nThe VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or older.\n\nThe objective of this study is to evaluate the diagnostic accuracy of the VIDAS® NEPHROCLEAR™ CCL14 test when used on the VIDAS® 3 instrument. Sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), likelihood ratios (LR), and relative risk (RR), will be evaluated at the pre-determined cut-off values.\n\nPreviously collected urine samples from persons with Stage 2 to Stage 3 AKI will be tested in this study. The VIDAS® test results will be compared to the clinical AKI status established by independent adjudication by medical professionals, that are blinded to the VIDAS® test results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons with Stage 2 to Stage 3 AKI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females 21 years of age or older;\n* Receiving care in an intensive care unit;\n* Expected to remain in the ICU for at least 48 hours after enrollment;\n* Use of indwelling urinary catheter as standard care at the time of enrollment;\n* Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;\n* Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria;\n* Documented informed consent provided by patient or legally authorized representative (LAR).\n\nExclusion Criteria:\n\n* Prior kidney transplantation;\n* Comfort-measures-only status;\n* Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;\n* Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic); (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.)\n* Special populations, pregnant women, prisoners or institutionalized individuals;'}, 'identificationModule': {'nctId': 'NCT06036758', 'briefTitle': 'VIDAS® NEPHROCLEAR Diagnostic Accuracy Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioMérieux'}, 'officialTitle': 'VIDAS® NEPHROCLEAR CCL14 Diagnostic Accuracy Study', 'orgStudyIdInfo': {'id': 'B3166-CTPR02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Persons with Stage 2 to Stage 3 AKI', 'description': 'Persons with Stage 2 to Stage 3 AKI who are in the ICU.', 'interventionNames': ['Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test']}], 'interventions': [{'name': 'VIDAS® NEPHROCLEAR™ CCL14 Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Urine samples previously collected from persons with stage 2/stage 3 AKI will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test', 'armGroupLabels': ['Persons with Stage 2 to Stage 3 AKI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20052', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioMérieux', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}