NCT05955924 Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
| NCT ID | NCT05955924 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Women's College Hospital |
| Condition | Non-melanoma Skin Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 396 participants |
| Start Date | 2023-08-28 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 396 participants in total. It began in 2023-08-28 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
An-Wen Chan
PRINCIPAL INVESTIGATOR
Women's College Hospital
Frequently Asked Questions
Who can join the NCT05955924 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-melanoma Skin Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05955924 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 396 participants.
Is NCT05955924 currently recruiting?
Yes, NCT05955924 is actively recruiting participants. Contact the research team at sprintr@wchospital.ca for enrollment information.
Where is the NCT05955924 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, Vancouver, Canada, Vancouver, Canada and 3 additional locations.
Who is sponsoring the NCT05955924 clinical trial?
NCT05955924 is sponsored by Women's College Hospital. The principal investigator is An-Wen Chan at Women's College Hospital. The trial plans to enroll 396 participants.
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