[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597609":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":17,"locations":26,"responsibleParty":180,"collaborators":7,"id":182,"slug":183,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":7,"eligibilityCriteria":188,"healthyVolunteers":184,"sex":189,"minAge":190,"maxAge":7,"enrollmentInfo":191,"targetDuration":7,"studyType":194,"phases":7,"briefSummary":195,"conditions":196,"keywords":7,"overallStatus":43,"whyStopped":7,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},{"fullName":5,"class":6},"Insight Molecular Diagnostics","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","donor-derived cell-free DNA test","A donor-derived cell-free DNA (dd-cfDNA) test used to measure the concentration of total cell-free DNA and the fractional abundance of the dd-cfDNA.",[14],{"name":15,"affiliation":5,"role":16},"Ekkehard Schuetz, MD, PhD","STUDY_CHAIR",[18,23],{"name":19,"role":20,"phone":21,"phoneExt":7,"email":22},"Robert Rogers, M.S.","CONTACT","14436258427","rrogers@imdxinc.com",{"name":15,"role":20,"phone":24,"phoneExt":7,"email":25},"615-927-1528","eschuetz@imdxinc.com",[27,41,60,79,96,106,123,142,159,171],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":7},"University of Southern California Keck School of Medicine","ACTIVE_NOT_RECRUITING","Los Angeles","California","90033","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-118.24368,34.05223,{"lat":39,"lon":38},{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":33,"countryCode":34,"cosmosGeoPoint":47,"geoPoint":51,"contacts":52},"Mayo Clinic in 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McAllister","214-820-1710","Ashley.McAllister@BSWHealth.org",{"facility":143,"status":43,"city":144,"state":145,"zip":146,"country":33,"countryCode":34,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Intermountain Health","Murray","Utah","84107",{"type":36,"coordinates":148},[149,150],-111.88799,40.66689,{"lat":150,"lon":149},[153,157],{"name":154,"role":20,"phone":155,"phoneExt":7,"email":156},"Shannon Sell","801-507-8390","Shannon.sell@imail.org",{"name":158,"role":59,"phone":7,"phoneExt":7,"email":7},"Sanjiv Anand, MD",{"facility":160,"status":29,"city":161,"state":162,"zip":163,"country":164,"countryCode":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":7},"Institute of Immunology - Transplantation Immunology","Heidelberg","Baden-Wurttemberg","69120","Germany","DE",{"type":36,"coordinates":167},[168,169],8.69079,49.40768,{"lat":169,"lon":168},{"facility":172,"status":29,"city":173,"state":7,"zip":174,"country":164,"countryCode":165,"cosmosGeoPoint":175,"geoPoint":179,"contacts":7},"Charite Universitatsmedizin","Berlin","10117",{"type":36,"coordinates":176},[177,178],13.41053,52.52437,{"lat":178,"lon":177},{"type":181,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100597609","validation-of-donor-derived-cell-free-dna-dd-cfdna-for-kidney-transplant-monitoring-100597609",false,"NCT07060716","Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring","GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring","Inclusion Criteria:\n\n1. Subject is 18 years of age or older\n2. At least 12 calendar days have elapsed since the subject received a kidney transplant.\n3. Subject has provided legally effective informed consent\n4. Subject agrees to comply with all study procedures\n\nExclusion Criteria:\n\n1. Kidney donor is an identical twin of the subject.\n2. The subject has another previously transplanted organ in situ.\n3. Subject has received a hematopoietic stem cell transplant.\n4. Subject has received a bone marrow graft.\n5. Subject has self-reported as pregnant.\n6. In the opinion of the investigator, the subject's participation in the study would pose a risk to data integrity or to the subject's safety and welfare.\n\nSample Inclusion Criteria:\n\n1\\. A graft biopsy is obtained within ±1 week of blood draw.\n\n* If blood draw is obtained after biopsy, blood draw should be taken at least 2 days after an uncomplicated biopsy procedure.\n\nSample Exclusion Criteria:\n\n1. Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw.\n2. Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw\n3. Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw.\n4. Sample collected from a subject that provided another sample for the study within the past 7 days.","ALL","18 Years",{"count":192,"type":193},125,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.\n\nResearchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.",[197,198],"Kidney Transplant Rejection","Cell-free DNA","2025-11-18",{"date":201,"type":202},"2025-11-19","ACTUAL",{"date":204,"type":202},"2025-09-08",{"date":206,"type":193},"2025-12",{"name":5,"class":6},10]