[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656486":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":11,"studyPopulation":11,"armGroups":40,"interventions":48,"overallOfficials":59,"centralContacts":11,"locations":11,"responsibleParty":63,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":11,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":11,"enrollmentInfo":77,"targetDuration":11,"studyType":80,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":88,"whyStopped":11,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":11},{"fullName":5,"class":6},"Duke University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Delayed Graft Function (DGF) severity, defined as time to freedom from dialysis",null,"through 90 days post-transplant",[14,18,21,24,27,31],{"measure":15,"description":16,"timeFrame":17},"Allograft biopsy rate","Number of allograft biopsies","first post transplant year",{"measure":19,"description":20,"timeFrame":17},"Health Care Resource Utilization (hospital length of stay)","Hospital length of stay",{"measure":22,"description":23,"timeFrame":17},"Health Care Resource Utilization (readmission rate)","Hospital readmission rate",{"measure":25,"description":26,"timeFrame":17},"Health Care Resource Utilization (days in intensive care unit)","Days in the intensive care unit",{"measure":28,"description":29,"timeFrame":30},"Dialysis utilization","number of dialysis sessions","90 days after transplant procedure",{"measure":32,"description":33,"timeFrame":30},"Health care related quality of life","Change in PROMIS measures",{"allocation":35,"interventionModel":36,"interventionModelDescription":11,"primaryPurpose":37,"observationalModel":11,"timePerspective":11,"maskingInfo":38},"NA","SINGLE_GROUP","HEALTH_SERVICES_RESEARCH",{"masking":39,"maskingDescription":11,"whoMasked":11},"NONE",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"TxAccess Intervention Arm","EXPERIMENTAL","Participants receive standard post-transplant care with deployment of the TxAccess platform and dd-cfDNA monitoring.",[46,47],"Device: TxAccess","Diagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA)",[49,54],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":11},"DEVICE","TxAccess","Software platform facilitating communication between transplant centers, nephrology practices, and dialysis facilities.",[42],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":11},"DIAGNOSTIC_TEST","Donor-Derived Cell-Free DNA (dd-cfDNA)","Blood testing to assess allograft injury and immunologic outcomes.",[42],[60],{"name":61,"affiliation":5,"role":62},"Lisa McElroy","PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[66],{"name":67,"class":68},"CareDx, Inc.","UNKNOWN","100656486","txaccess-and-dd-cfdna-for-improved-care-of-patients-with-delayed-graft-function-100656486",false,"NCT07825688","TxAccess and Dd-cfDNA for Improved Care of Patients With Delayed Graft Function","Study Population: Patients Inclusion criteria: Adult patients who experienced delayed graft function after a deceased donor kidney transplant in the last 2 calendar years\n\nExclusion criteria: Patients younger than 18 years old at the time of transplant; patients who experienced graft loss prior to discharge from their index hospitalization patients who receive outpatient dialysis at a center that does not utilize TxAccess (intervention period)\n\nStudy Population: Clinicians Inclusion criteria: adult clinicians who participate in care of kidney transplant recipients, including surgeons, nephrologists, pharmacists, social workers, nurse coordinators, advanced practice providers, nurses, case managers and dialysis center clinicians and staff.\n\nExclusion criteria: clinicians and staff who are not employed at participating centers or do not have direct patient contact or experience with care coordination","ALL","18 Years",{"count":78,"type":79},450,"ESTIMATED","INTERVENTIONAL",[35],"This is a prospective multicenter nonrandomized pragmatic hybrid effectiveness-implementation study to test the effectiveness of TxAccess in improving time to renal recovery and immunologic outcomes in patients with delayed graft function (DGF) and to assess barriers and facilitators to implementation of TxAccess in the post-transplant care period. Research blood will be collected for donor-derived cell-free DNA testing, and patient questionnaires will be administered.",[84],"Delayed Graft Function",[86,84,87],"Kidney Transplant","Donor-Derived Cell-Free DNA","NOT_YET_RECRUITING","2026-09-12",{"date":91,"type":92},"2026-09-17","ACTUAL",{"date":94,"type":79},"2026-09-15",{"date":96,"type":79},"2029-06-30",{"name":5,"class":6}]