NCT05955924RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 396 (estimated)
- First submitted
- 13 Jul 2023
- Start date
- 28 Aug 2023
- Primary completion date
- Aug 2027
- Lead sponsor
- Women's College Hospital
- Diseases
- Melanoma
- NCT number
- NCT05955924
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 396
- From 28 Aug 2023 to the primary completion date, Aug 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Active liver disease (high AST \>3 times or bilirubin \>1.5 times)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Not yet recruiting |
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Women's College Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| St. Paul's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.