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

NCT05955924 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2025-02-21

No results posted yet for this study

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.

Conditions

  • Non-melanoma Skin Cancer
  • Carcinoma, Squamous Cell
  • Carcinoma, Basal Cell
  • Keratinocyte Carcinoma

Interventions

DRUG

Nicotinamide

Oral nicotinamide (500 mg) twice daily

DRUG

Placebo

Matching placebo capsule twice daily

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University Health Network, Toronto

    collaborator OTHER

  • NOW Foods

    collaborator OTHER

  • Women's College Hospital

    lead OTHER

Principal Investigators

  • An-Wen Chan · Women's College Hospital

  • Sang Joseph Kim · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-28
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05955924 on ClinicalTrials.gov