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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":172,"type":173},396,"ESTIMATED","INTERVENTIONAL",[176],"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.",[179,180,181,182],"Non-melanoma Skin Cancer","Carcinoma, Squamous Cell","Carcinoma, Basal Cell","Keratinocyte Carcinoma","2025-02-20",{"date":185,"type":186},"2025-02-21","ACTUAL",{"date":188,"type":186},"2023-08-28",{"date":190,"type":173},"2027-08",{"name":5,"class":6},7]