[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457876":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":28,"locations":38,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":25,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Alberta","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Envarsus","ACTIVE_COMPARATOR","Envarsus tablet Dose 0.11 - 0.13 mg\u002FKg\u002Fday Frequency: once per day",[13],"Drug: Envarsus Oral Product",{"label":15,"type":6,"description":16,"interventionNames":17},"Prograf (SOC)","Prograf tablet Dose 0.10 - 0.15mg\u002FKg daily Frequency: 2 doses per day (dose above split in half for each dose)",[18],"Drug: Prograf (SOC)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Envarsus Oral Product","as described in arm\u002Fgroup description",[9],null,{"type":21,"name":15,"description":15,"armGroupLabels":27,"otherNames":25},[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Rahima A Bhanji, MD","CONTACT","780-492-2235","rbhanji@ualberta.ca",{"name":35,"role":31,"phone":36,"phoneExt":25,"email":37},"Nadia Shular, RN","587-588-7231","nadiashular@ualberta.ca",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Univerity of Alberta","RECRUITING","Edmonton","Alberta","T6G 2R3","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-113.46871,53.55014,{"lat":51,"lon":50},[54,56],{"name":55,"role":31,"phone":32,"phoneExt":25,"email":33},"Rahima Bhanji, MD",{"name":55,"role":57,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100457876","phase-4-extended-release-tacrolimus-following-liver-transplantation-100457876",false,"NCT05242315","Extended-Release Tacrolimus Following Liver Transplantation","Feasibility, Efficacy And Safety Of De Novo Extended-Release Tacrolimus Following Liver Transplantation","Inclusion Criteria:\n\n\\- Adult individuals transplanted at the University of Alberta\n\nExclusion Criteria:\n\n* Individuals with congenital long QT syndrome\n* Patients with elevated bilirubin \\> 100 umol\u002FL post-LT (at day 3)\n* Patients with chronic kidney disease (eGFR \\\u003C 45 ml per minute per 1.73 m2)\n* Patients with acute kidney injury requiring discontinuation of calcineurin inhibitors.\n* Patients who have hepatocellular carcinoma, require a re-transplant, or receive multi-visceral transplant","ALL","18 Years",{"count":70,"type":71},94,"ESTIMATED","INTERVENTIONAL",[74],"PHASE4","Medications used after transplant to prevent rejection are associated with many side effects. Tacrolimus side effects include kidney dysfunction; tremor, headaches, difficulty sleeping, change in sensation (legs), seizure, or confusion; high blood pressure; anemia, or low blood cell counts; diabetes; abnormal cholesterol and weight gain. The investigators want to use a new, approved, formulation of the standard medication (Envarsus) as they believe it may be associated with reduced side effects. The investigators would like to assess how safe it is to use this medication and how well it works in comparison to currently used formulations. The investigators will study if there are less side effects and will study clinical outcomes (including how well the liver does and if there is need for hospitalizations after transplant).\n\nThe investigators hope that this information will improve the care provided to and outcomes in patients following liver transplant.",[77,78,79,80,81],"Liver Transplant; Complications","Renal Insufficiency","Immunosuppressant Adverse Reaction","Metabolic Syndrome","Cardiovascular Diseases","2025-08-19",{"date":84,"type":85},"2025-08-21","ACTUAL",{"date":87,"type":85},"2022-05-15",{"date":89,"type":71},"2034-02-15",{"name":5,"class":6},1]