Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• Use of nicotinamide or niacin (≥250 mg daily) within past 12 weeks
• Untreated localized skin cancer at baseline (patient can enrol after skin cancer treatment)
• Biopsy-confirmed acute rejection episode within the past 12 weeks
• Active liver disease (high AST >3 times or bilirubin >1.5 times)
• 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
• Pregnancy or lactation
• Need for ongoing carbamazepine or primidone
• Allergy to nicotinamide or any ingredient of the vitamin or placebo capsules

Where this trial is running

• University of Calgary, Calgary, Alberta, Canada
• University of Alberta, Edmonton, Alberta, Canada
• Vancouver General Hospital, Vancouver, British Columbia, Canada
• St. Paul's Hospital, Vancouver, British Columbia, Canada
• The Ottawa Hospital, Ottawa, Ontario, Canada
• Toronto General Hospital, Toronto, Ontario, Canada
• Women's College Hospital, Toronto, Ontario, Canada

Who to contact

Stephanie Jewell, BSc. Hons · 416 351-3732 · sprintr@wchospital.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05955924.