[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573877":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":49,"responsibleParty":68,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":47,"enrollmentInfo":84,"targetDuration":47,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":52,"whyStopped":47,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Envarsus XR conversion","EXPERIMENTAL","Patients who are randomized to this group will receive extended-release tacrolimus (Envarsus XR) at 80 percent of their total daily dose of IR tacrolimus (Prograf) before the switch. Tacrolimus trough level will be obtained 3-4 weeks after the conversion to ensure appropriate dosage.",[13],"Drug: Conversion to extended-release tacrolimus",{"label":15,"type":16,"description":17,"interventionNames":18},"Prograf maintenance","ACTIVE_COMPARATOR","Patients in the IR tacrolimus (Prograf) maintenance group will continue with their current dose of IR tacrolimus (Prograf) before enrollment unless the drug trough levels deviate from the therapeutic range.",[19],"Drug: Maintenance of immediate-release tacrolimus",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Conversion to extended-release tacrolimus","Conversion from immediate-release tacrolimus (Prograf) to extended-release tacrolimus (Envarsus XR) as a part of the maintenance immunosuppressive treatment",[9],[27],"Envarsus XR",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Maintenance of immediate-release tacrolimus","Continuing immediate-release tacrolimus (Prograf) as a part of the maintenance immunosuppressive treatment",[15],[33],"Prograf",[35],{"name":36,"affiliation":5,"role":37},"Leonardo V. Riella, MD, PhD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","6177240345","40345","lriella@mgh.harvard.edu",{"name":45,"role":40,"phone":46,"phoneExt":47,"email":48},"Amelia Stocking","617-724-1976",null,"astocking@mgh.harvard.edu",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"MGH Kidney Transplant Clinic","RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-71.05977,42.35843,{"lat":62,"lon":61},[65],{"name":66,"role":40,"phone":67,"phoneExt":47,"email":43},"Riella, M.D., Ph.D.","877-644-2860",{"type":37,"investigatorFullName":36,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Medical Director of Kidney Transplantation",[71],{"name":72,"class":73},"Veloxis Pharmaceuticals","INDUSTRY","100573877","phase-4-neurocognitive-function-changes-with-extended-release-tacrolimus-among-older-kidney-transplant-recipients-100573877",false,"NCT06751992","Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients","Neurocognitive Function Changes With Once-Daily Extended-Release Tacrolimus (Envarsus XR) Conversion Compared to Twice-Daily Immediate Release Tacrolimus Maintenance Among Older Kidney Transplant Recipients","Neuro-KTR","Inclusion Criteria:\n\n* Able to give informed consent for participation in the study\n* Patients who have regular outpatient follow-up at the Massachusetts General Hospital (MGH) transplant center\n* ≥1 year since the latest kidney transplantation\n* On IR tacrolimus as maintenance therapy\n* At a stable therapeutic tacrolimus level (5-10 ng\u002Fml) over the last ≥3 months\n* Stable kidney function \\[\\\u003C20% variability between the last two estimated glomerular filtration rate (eGFR)\\]\n* Utilizing English or Spanish as the primary language\n\nExclusion Criteria:\n\n* Dual organ transplantation\n* Rejection within the last three months\n* History of moderate to severe dementia (defined by Dementia Severity Rating Scale ≥19)\n* History of Parkinson's disease\n* Decompensated liver disease\n* Active cancer\n* Uncontrolled depression or anxiety\n* Blindness\n* Deafness\n* Intellectual disabilities\n* Pregnancy\n* eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m2 at the time of enrollment\n* Total bilirubin \\>3.0 mg\u002FdL","ALL","65 Years",{"count":85,"type":86},92,"ESTIMATED","INTERVENTIONAL",[89],"PHASE4","The objective of this randomized controlled study is to assess the neurocognitive outcomes between individuals using immediate-release (IR) tacrolimus (Prograf®) and those who were converted to extended-release tacrolimus (Envarsus XR) among older kidney transplant recipients (KTRs).",[92,93],"Kidney Transplant Recipients","Old Age",[95,96,97,98,99],"Neurocognitive function","Tacrolimus","Kidney transplant recipients","Tremor","Insomnia","2026-05-26",{"date":102,"type":103},"2026-05-28","ACTUAL",{"date":105,"type":103},"2026-03-17",{"date":107,"type":86},"2027-10-01",{"name":5,"class":6},1]