[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446143":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":41,"locations":51,"responsibleParty":71,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":11,"enrollmentInfo":86,"targetDuration":11,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LCPT","EXPERIMENTAL",null,[13],"Drug: Tacrolimus Extended Release Oral Tablet",{"label":15,"type":16,"description":11,"interventionNames":17},"IR-TAC","ACTIVE_COMPARATOR",[18],"Drug: Tacrolimus, Immediate Release, Oral",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Tacrolimus, Immediate Release, Oral","Twice Daily Tacrolimus",[15],[26,27],"Tacrolimus, Sandoz","Prograf",{"type":21,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Tacrolimus Extended Release Oral Tablet","Once Daily Tacrolimus",[9],[33],"Envarsus",[35,38],{"name":36,"affiliation":5,"role":37},"Trana Hussaini, Pharm D","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":40},"Jo-Ann Ford, RN","STUDY_CHAIR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":11,"email":46},"Trana Hussaini","CONTACT","6043284930","trana.hussaini@vch.ca",{"name":48,"role":44,"phone":49,"phoneExt":11,"email":50},"Eric Yoshida, MD","604-872-9858","eric.yoshida@vch.ca",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Vancouver General Hospital","RECRUITING","Vancouver","British Columbia","V5Z 1M9","Canada","CA",{"type":61,"coordinates":62},"Point",[63,64],-123.11934,49.24966,{"lat":64,"lon":63},[67,68],{"name":43,"role":44,"phone":45,"phoneExt":11,"email":46},{"name":69,"role":44,"phone":11,"phoneExt":11,"email":70},"Jo-Ann Ford","jo-ann.ford@vch.ca",{"type":37,"investigatorFullName":43,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Clinical Assistant Professor",[74],{"name":75,"class":6},"Paladin Labs Inc.","100446143","phase-4-tacrolimus-associated-tremors-in-liver-transplantation-immediate-release-versus-extended-release-formulations-100446143",false,"NCT05089604","Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations","Tacrolimus Associated Tremors in Liver Transplant Recipients: a Randomized Open Label Trial Comparing De Novo Extended-release Once Daily (LCP-TAC) and Twice Daily Immediate-release (IR-TAC) Tacrolimus Formulations","LCP-TAC","Inclusion Criteria:\n\n1. Adults aged 18 years or older\n2. Recipients of a first-time liver transplant\n3. eGFR more than 30 ml\u002Fmin on the day of tacrolimus initiation\n4. All patients who are eligible to initiate Tacrolimus within 7 days post-liver transplant\n5. Informed consent\n\nExclusion Criteria:\n\n1. Recipients of prior organ transplant\n2. Need for hemodialysis either prior or following liver transplantation\n3. Recipients of living donor liver or split deceased donor liver allografts\n4. Recipients of combined liver\u002Fkidney transplants\n5. Recipients receiving liver allografts from donors with HCV viremia (detected through nucleic acid testing or other means)\n6. Patients with a history of tremor prior to transplantation including essential tremors, Parkinson's or Parkinsonian syndromes\n7. Patients receiving concomitant medications known to induce tremors such as dopamine blocking agents\n8. Baseline TSH, T3, T4 indicating hyperthyroidism","ALL","18 Years",{"count":87,"type":88},124,"ESTIMATED","INTERVENTIONAL",[91],"PHASE4","This is a randomized open label study in de novo liver transplant recipients that aims to compare the risk of tacrolimus induced tremors with once daily extended-release formulation, Envarsus, versus the twice daily immediate-release formulation. Both formulations of tacrolimus are currently approved for the prevention of rejection in liver transplant patients.",[94,95,96,97,98],"Liver Transplantation","Immunosuppression","Neurotoxicity","Tremor","Tacrolimus",[100,98,95,97,33,82,96],"Liver Transplant","2023-12-27",{"date":103,"type":104},"2024-01-02","ACTUAL",{"date":106,"type":104},"2023-01-09",{"date":108,"type":88},"2026-12-31",{"name":5,"class":6},1]