Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-28 @ 10:03 PM
Study NCT ID:
NCT04802395
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2021-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real World Evidence Clinical Utility Study of KidneyIntelX
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003928', 'term': 'Diabetic Nephropathies'}], '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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-11', 'studyFirstSubmitDate': '2021-03-12', 'studyFirstSubmitQcDate': '2021-03-12', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Referrals', 'timeFrame': '6 Months', 'description': 'Proportion (target: 20%) of patients referred to a dietician, diabetologist, or nephrologist.'}, {'measure': 'Statins and or ACEi/ARB', 'timeFrame': '6 Months', 'description': 'Proportion (target: 20% increase) of patients treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.'}, {'measure': 'HbA1c', 'timeFrame': '6 Months', 'description': 'Proportion (target: 20% increase) of patients to receive information and or advice on their individualized target of HbA1c.'}, {'measure': 'SGLT2/ GLP1', 'timeFrame': '6 Months', 'description': 'Proportion (target: 20% increase) of patients treated with SGLT2 inhibitors or GLP1 agonists.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Diseases', 'Diabetic Kidney Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '23 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Type 2 diabetes and existing chronic kidney disease stages 1-3.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.\n\nExclusion Criteria:\n\n* Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population.\n* Patients with eGFR \\<30 or ≥ 60 ml/min/1.73m2 without albuminuria.\n* Patients with ESRD or on renal recovery treatments at time of enrollment.\n* Patients who are pregnant at the time of enrollment.\n* Patients who are currently hospitalized.\n* Patients without minimum 6 month pre-baseline KidneyIntelX medical history.\n* Patients who are currently on Enbrel.'}, 'identificationModule': {'nctId': 'NCT04802395', 'briefTitle': 'Real World Evidence Clinical Utility Study of KidneyIntelX', 'organization': {'class': 'INDUSTRY', 'fullName': 'Renalytix AI, Inc.'}, 'officialTitle': 'Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'RAI 19-1004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'KidneyIntelX', 'type': 'DIAGNOSTIC_TEST', 'description': 'KidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function in patients with type 2 diabetes and existing CKD at stages 1-3 (eGFR of 30 to 59 ml/min/1.73m2, or eGFR ≥ 60 ml/min/1.73m2 and uACR ≥ 30 mg/g).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mount Sinai Health System', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Roger Tun', 'role': 'CONTACT', 'email': 'rtun@renalytix.com', 'phone': '646-397-3970', 'phoneExt': '106'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renalytix AI, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Mount Sinai Hospital, New York', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}