Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04791358
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2021-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Decision Impact Trial of KidneyIntelX
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'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': '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': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-11', 'studyFirstSubmitDate': '2021-03-04', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '12 Months', 'description': 'Proportion (target: 20% increase from prior measurements) of visits in which each participant achieves target blood pressure of \\<140/90 mmHg (as per the NKF CKD management guidelines).'}, {'measure': 'HbA1c', 'timeFrame': '12 Months', 'description': 'Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c.'}, {'measure': 'ACEi/ARB', 'timeFrame': '12 Months', 'description': 'Proportion (target: 20% increase) of patients recently treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.'}, {'measure': 'SGLT2/ GLP1', 'timeFrame': '12 Months', 'description': 'Proportion (target: 20% increase) of patients recently treated with SGLT2 inhibitors or GLP1 agonists.'}, {'measure': 'Urine albumin to creatinine ratio', 'timeFrame': '12 Months', 'description': 'In those with baseline albuminuria, proportion (target: 20%) of patients achieving a 30% decrease in their urine albumin to creatinine ratio from averaged pre-enrollment values to average post-enrollment values through 1 year.'}, {'measure': 'Referrals', 'timeFrame': '12 Months', 'description': 'Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The current trial is designed to evaluate how the results of KidneyIntelX test impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.'}, '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* 23 years of age or older.\n* Clinical history of confirmed type 2 diabetes.\n* Evidence of DKD Stages 1-3:\n* Baseline eGFR of 30-60 ml/min/1.73m2 (confirmed 3 months apart with at least one value within 1 year prior to enrollment)\n* Individuals with eGFR ≥60 ml/min/1.73m2 and albuminuria (UACR ≥30mg/g)\n* All patients will have a HbA1c, eGFR, urine albumin and urine creatinine, eGFR, available from within 12 months of enrollment (to be obtained if not clinically available prior).\n* The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.\n\nExclusion Criteria:\n\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 who are currently on Enbrel.'}, 'identificationModule': {'nctId': 'NCT04791358', 'briefTitle': 'Decision Impact Trial of KidneyIntelX', 'organization': {'class': 'INDUSTRY', 'fullName': 'Renalytix AI, Inc.'}, 'officialTitle': 'A Prospective Decision Impact Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'RAI 20-1001'}}, '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 and kidney failure 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': '12159', 'city': 'Slingerlands', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Delmar Family Medicine', 'geoPoint': {'lat': 42.62925, 'lon': -73.86457}}], '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'}, 'responsibleParty': {'type': 'SPONSOR'}}}}