[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512705":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":45,"responsibleParty":154,"collaborators":156,"id":163,"slug":164,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":165,"sex":171,"minAge":172,"maxAge":30,"enrollmentInfo":173,"targetDuration":30,"studyType":176,"phases":177,"briefSummary":179,"conditions":180,"keywords":30,"overallStatus":68,"whyStopped":30,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"fullName":5,"class":6},"Women's College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nicotinamide","EXPERIMENTAL","Intervention Drug : Nicotinamide",[13],"Drug: Nicotinamide",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Intervention: Placebo Oral Capsule",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Oral nicotinamide (500 mg) twice daily",[9],[26],"niacinamide",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Matching placebo capsule twice daily",[15],null,[32,35],{"name":33,"affiliation":5,"role":34},"An-Wen Chan","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Sang Joseph Kim","University Health Network, Toronto",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Stephanie Jewell, BSc. Hons","CONTACT","416 351-3732","2706","sprintr@wchospital.ca",[46,66,85,101,115,131,145],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University of Calgary","NOT_YET_RECRUITING","Calgary","Alberta","T2N 1N4","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-114.08529,51.05011,{"lat":58,"lon":57},[61,64],{"name":62,"role":41,"phone":30,"phoneExt":30,"email":63},"Coralea Bignell","coralea.bignell@albertahealthservices.ca",{"name":65,"role":34,"phone":30,"phoneExt":30,"email":30},"Ngam Lam",{"facility":67,"status":68,"city":69,"state":50,"zip":70,"country":52,"countryCode":53,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"University of Alberta","RECRUITING","Edmonton","T6G 2R3",{"type":55,"coordinates":72},[73,74],-113.46871,53.55014,{"lat":74,"lon":73},[77,80,82],{"name":78,"role":41,"phone":30,"phoneExt":30,"email":79},"Kelly Kim","kkim6@ualberta.ca",{"name":81,"role":34,"phone":30,"phoneExt":30,"email":30},"Sita Gourishankar",{"name":83,"role":84,"phone":30,"phoneExt":30,"email":30},"Jaggi Rao","SUB_INVESTIGATOR",{"facility":86,"status":68,"city":87,"state":88,"zip":89,"country":52,"countryCode":53,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Vancouver General Hospital","Vancouver","British Columbia","V5Z 1M9",{"type":55,"coordinates":91},[92,93],-123.11934,49.24966,{"lat":93,"lon":92},[96,99],{"name":97,"role":41,"phone":30,"phoneExt":30,"email":98},"Natalie Ng","natalie.ng@ubc.ca",{"name":100,"role":34,"phone":30,"phoneExt":30,"email":30},"Sunil Kalia",{"facility":102,"status":68,"city":87,"state":88,"zip":103,"country":52,"countryCode":53,"cosmosGeoPoint":104,"geoPoint":106,"contacts":107},"St. Paul's Hospital","V6Z 1Y6",{"type":55,"coordinates":105},[92,93],{"lat":93,"lon":92},[108,111,113],{"name":109,"role":41,"phone":30,"phoneExt":30,"email":110},"Anushka Sood","asood1@providencehealth.bc.ca",{"name":112,"role":34,"phone":30,"phoneExt":30,"email":30},"John Gill",{"name":114,"role":84,"phone":30,"phoneExt":30,"email":30},"Sheila Au",{"facility":116,"status":68,"city":117,"state":118,"zip":119,"country":52,"countryCode":53,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"The Ottawa Hospital","Ottawa","Ontario","K1Y 4E9",{"type":55,"coordinates":121},[122,123],-75.69812,45.41117,{"lat":123,"lon":122},[126,129],{"name":127,"role":41,"phone":30,"phoneExt":30,"email":128},"Christine Lennox","clennox@ohri.ca",{"name":130,"role":34,"phone":30,"phoneExt":30,"email":30},"Jennifer Beecker",{"facility":132,"status":68,"city":133,"state":118,"zip":134,"country":52,"countryCode":53,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Toronto General Hospital","Toronto","M5G 2C4",{"type":55,"coordinates":136},[137,138],-79.39864,43.70643,{"lat":138,"lon":137},[141,144],{"name":142,"role":41,"phone":30,"phoneExt":30,"email":143},"Marsida Stafa","SPRINTR@wchospital.ca",{"name":33,"role":34,"phone":30,"phoneExt":30,"email":30},{"facility":5,"status":68,"city":133,"state":118,"zip":146,"country":52,"countryCode":53,"cosmosGeoPoint":147,"geoPoint":149,"contacts":150},"M5S 1B2",{"type":55,"coordinates":148},[137,138],{"lat":138,"lon":137},[151,153],{"name":152,"role":41,"phone":30,"phoneExt":30,"email":143},"Stephanie Jewell",{"name":33,"role":34,"phone":30,"phoneExt":30,"email":30},{"type":155,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[157,160,161],{"name":158,"class":159},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":37,"class":6},{"name":162,"class":6},"NOW Foods","100512705","phase-3-nicotinamide-chemoprevention-for-keratinocyte-carcinoma-in-solid-organ-transplant-recipients---pivotal-trial-100512705",false,"NCT05955924","Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial","Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: a Multicentre, Pragmatic Randomized Trial","SPRINTR","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Kidney, liver, heart, or lung transplant at least two years ago\n* History of at least one prior histologically-confirmed keratinocyte carcinoma or squamous cell carcinoma in situ\n* Currently immunosuppressed with a calcineurin inhibitor-based regimen (cyclosporine or tacrolimus)\n* Able to attend follow-up visits\n\nExclusion Criteria:\n\n* Use of nicotinamide or niacin (≥250 mg daily) within past 12 weeks\n* Untreated localized skin cancer at baseline (patient can enrol after skin cancer treatment)\n* Biopsy-confirmed acute rejection episode within the past 12 weeks\n* Active liver disease (high AST \\>3 times or bilirubin \\>1.5 times)\n* Severe kidney disease (estimated glomerular filtration rate \\\u003C20 mL\u002Fmin\u002F1.73 m2)\n* Solid organ or hematologic malignancy, invasive melanoma, Merkel cell carcinoma, or metastatic skin cancer within the past five years\n* Pregnancy or lactation\n* Need for ongoing carbamazepine or primidone\n* Allergy to nicotinamide or any ingredient of the vitamin or placebo capsules","ALL","18 Years",{"count":174,"type":175},396,"ESTIMATED","INTERVENTIONAL",[178],"PHASE3","As patients live longer after receiving an organ transplant, there is a need to reduce the long-term side effects of the drugs used to prevent organ rejection. In particular, long-term use of these drugs increases the risk of skin cancer. Skin cancer is now a leading cause of illness and disfigurement after kidney, liver, heart, and lung transplantation. Given the increased risk and burden of skin cancer in transplant recipients, prevention is critical.\n\nNicotinamide is a form of Vitamin B3 that has been shown to protect against skin cancer in the general population. However, it is unclear whether nicotinamide is effective among immune-suppressed transplant recipients. Investigators will conduct a clinical trial involving multiple transplant centres in Canada to evaluate whether oral nicotinamide (500 mg twice daily) is effective and safe for preventing skin cancer. Investigators will recruit 396 high-risk adult kidney, liver, heart, and lung transplant patients who have previously had at least one skin cancer. Patients will receive nicotinamide or sham tablets for up to 4 years. The results will inform efforts to improve the long-term health of transplant recipients.",[181,182,183,184],"Non-melanoma Skin Cancer","Carcinoma, Squamous Cell","Carcinoma, Basal Cell","Keratinocyte Carcinoma","2025-02-20",{"date":187,"type":188},"2025-02-21","ACTUAL",{"date":190,"type":188},"2023-08-28",{"date":192,"type":175},"2027-08",{"name":5,"class":6},7]