Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
NCT ID: NCT05955924
Last Updated: 2025-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
396 participants
INTERVENTIONAL
2023-08-28
2027-08-31
Brief Summary
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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.
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Detailed Description
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Nicotinamide is a low-cost, commercially available, over-the-counter Vitamin B3 derivative that has been found to safely reduce the rate of keratinocyte carcinoma in immunocompetent patients with a history of skin cancer. It is unclear whether its efficacy and safety translate to the immunosuppressed transplant population.
Given this uncertainty, Investigators plan to build on our internal pilot study (N=120) to conduct the SPRINTR (Skin cancer PRevention with Nicotinamide in Transplant Recipients) pivotal trial to address these specific aims:
Primary question: Does oral nicotinamide (500 mg twice daily) reduce the rate of further keratinocyte carcinoma compared with placebo when used in addition to standard care for up to 208 weeks in high-risk solid organ transplant recipients?
Secondary questions:
1. What is the safety of nicotinamide when used in addition to standard care for up to 208 weeks in the transplant population?
2. What is the effect of nicotinamide on quality of life related to skin cancer?
Investigators will conduct a multicentre, pragmatic, parallel group, investigator- and patient-blinded, randomized trial with a superiority framework. This pivotal trial will evaluate the efficacy and safety of oral nicotinamide versus placebo to prevent further keratinocyte carcinoma in 396 high-risk solid organ transplant recipients. Data from our previous internal pilot study (N=120 participants) will be combined with data from the current pivotal trial (N=276 additional patients) in the final analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Nicotinamide
Intervention Drug : Nicotinamide
Nicotinamide
Oral nicotinamide (500 mg) twice daily
Placebo
Intervention: Placebo Oral Capsule
Placebo
Matching placebo capsule twice daily
Interventions
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Nicotinamide
Oral nicotinamide (500 mg) twice daily
Placebo
Matching placebo capsule twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
University Health Network, Toronto
OTHER
NOW Foods
OTHER
Women's College Hospital
OTHER
Responsible Party
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Principal Investigators
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An-Wen Chan
Role: PRINCIPAL_INVESTIGATOR
Women's College Hospital
Sang Joseph Kim
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SPRINTR-pivotal
Identifier Type: -
Identifier Source: org_study_id
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