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

RecruitingPhase 3Ages 18 Years - anyAllWomen's College Hospital
NCT05955924 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 re

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📋 Eligibility rules (as published)
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
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What it tests

  • Nicotinamide
  • Placebo
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Where

7 sites
University of Calgary
Calgary, Canada
University of Alberta
Edmonton, Canada
Vancouver General Hospital
Vancouver, Canada
St. Paul's Hospital
Vancouver, Canada
The Ottawa Hospital
Ottawa, Canada
Toronto General Hospital
Toronto, Canada
Women's College Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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