Tests nicotinamide to prevent skin cancer in organ transplant recipients
Tests nicotinamide, a vitamin B3 form, to prevent skin cancer in transplant patients.
Plain-language title generated from the registry record
Registry title: Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
Key facts
- Where
- Calgary, Edmonton, Ottawa, Toronto, and Vancouver, CanadaSee the 7 sites
- Phase
- Phase 3
Where in Canada
- University Of CalgaryCalgary, CanadaNot yet recruiting
- University of AlbertaEdmonton, CanadaTaking people
- The Ottawa HospitalOttawa, CanadaTaking people
- Toronto General HospitalToronto, CanadaTaking people
- Women's College HospitalToronto, CanadaTaking people
- St. Paul's HospitalVancouver, CanadaTaking people
- Vancouver General HospitalVancouver, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Women's College Hospital
- Trial code
- NCT05955924
- Record updated
- 13 October 2026
- Original description
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.Read full original descriptionShow less
Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: a Multicentre, Pragmatic Randomized Trial
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.
Nicotinamide 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.
Inclusion: Age ≥ 18 years old; Kidney, liver, heart, or lung transplant at least two years ago; History of at least one prior histologically-confirmed keratinocyte carcinoma or squamous cell carcinoma in situ; Currently immunosuppressed with a calcineurin inhibitor-based regimen (cyclosporine or tacrolimus); Able to attend follow-up visits.
Exclusion: Untreated localized skin cancer at baseline (patient can enrol after skin cancer treatment); Severe kidney disease (estimated glomerular filtration rate <20 mL/min/1.73 m2); Solid organ or hematologic malignancy, invasive melanoma, Merkel cell carcinoma, or metastatic skin cancer within the past five years; Allergy to nicotinamide or any ingredient of the vitamin or placebo capsules; Active liver disease (high AST >3 times or bilirubin >1.5 times); Use of nicotinamide or niacin (≥250 mg daily) within past 12 weeks; Biopsy-confirmed acute rejection episode within the past 12 weeks; Pregnancy or lactation; Need for ongoing carbamazepine or primidone.