[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100424092":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":20,"responsibleParty":34,"collaborators":36,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":7,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":7,"enrollmentInfo":49,"targetDuration":7,"studyType":52,"phases":7,"briefSummary":53,"conditions":54,"keywords":7,"overallStatus":23,"whyStopped":7,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},{"fullName":5,"class":6},"Renalytix AI, Inc.","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","KidneyIntelX","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\u002Fmin\u002F1.73m2, or eGFR ≥ 60 ml\u002Fmin\u002F1.73m2 and uACR ≥ 30 mg\u002Fg).",[14],{"name":15,"role":16,"phone":17,"phoneExt":18,"email":19},"Roger Tun","CONTACT","646-397-3970","106","rtun@renalytix.com",[21],{"facility":22,"status":23,"city":24,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":7},"Mount Sinai Health System","RECRUITING","New York","10029","United States","US",{"type":29,"coordinates":30},"Point",[31,32],-74.00597,40.71427,{"lat":32,"lon":31},{"type":35,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[37],{"name":38,"class":39},"Mount Sinai Hospital, New York","OTHER","100424092","real-world-evidence-clinical-utility-study-of-kidneyintelx-100424092",false,"NCT04802395","Real World Evidence Clinical Utility Study of KidneyIntelX","Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease","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 \\\u003C30 or ≥ 60 ml\u002Fmin\u002F1.73m2 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.","ALL","23 Years",{"count":50,"type":51},10000,"ESTIMATED","OBSERVATIONAL","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.",[55,56],"Chronic Kidney Diseases","Diabetic Kidney Disease","2024-04-11",{"date":59,"type":60},"2024-04-12","ACTUAL",{"date":62,"type":60},"2021-03-02",{"date":64,"type":51},"2026-12-01",{"name":5,"class":6},1]