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

• Status: Recruiting
• Trial end date: 2027-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Women's College Hospital
• Collaborators: Canadian Institutes of Health Research (CIHR); NOW Foods; University Health Network, Toronto
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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