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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03769285
Registration number
NCT03769285
Ethics application status
Date submitted
4/12/2018
Date registered
7/12/2018
Date last updated
6/04/2023
Titles & IDs
Public title
Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial
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Scientific title
Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: A Pilot, Placebo-controlled, Randomized Trial
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Secondary ID [1]
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SPRINTR-Pilot
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Universal Trial Number (UTN)
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Trial acronym
SPRINTR-Pilot
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-melanoma Skin Cancer
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Carcinoma, Squamous Cell
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Carcinoma, Basal Cell
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Nicotinamide
Treatment: Drugs - Placebo oral capsule
Experimental: Nicotinamide -
Placebo comparator: Placebo -
Treatment: Drugs: Nicotinamide
Oral nicotinamide (500 mg) twice daily for at least 52 weeks
Treatment: Drugs: Placebo oral capsule
Matching placebo taken twice daily for at least 52 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Feasibility (pertaining to patient recruitment)
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Assessment method [1]
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Proportion of patients who consent to data linkage to provincial administrative databases
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Timepoint [1]
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1 year
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Primary outcome [2]
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Feasibility (pertaining to appropriateness of eligibility criteria)
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Assessment method [2]
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Reasons for exclusion of screened patients
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Timepoint [2]
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1 year
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Primary outcome [3]
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Feasibility (pertaining to adherence to intervention)
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Assessment method [3]
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Proportion of capsules returned, reasons for non-adherence
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Timepoint [3]
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1 year
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Primary outcome [4]
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Feasibility (pertaining to adherence to follow-up assessments)
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Assessment method [4]
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Proportion of missed assessments and incomplete questionnaire data variables, proportion of patients who withdraw from the trial, patient perception of trial participation
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Timepoint [4]
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1 year
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Primary outcome [5]
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Feasibility (pertaining to data linkage)
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Assessment method [5]
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Proportion of patients who consent to data linkage to provincial administrative databases
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Timepoint [5]
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1 year
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Primary outcome [6]
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Preliminary pooled keratinocyte carcinoma event rate
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Assessment method [6]
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Pooled keratinocyte carcinoma event rate to be used for sample size re-estimation in the pivotal trial.
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Timepoint [6]
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1 year
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Primary outcome [7]
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Drug interactions
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Assessment method [7]
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Proportion of patients with a clinically relevant increase in cyclosporine or tacrolimus blood concentration at 1 week. An increased level will be classified as clinically relevant if the transplant physician reduces the immunosuppressant dose in response to the increased drug level.
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Timepoint [7]
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1 week
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Primary outcome [8]
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Drug interactions
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Assessment method [8]
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Proportion of patients with a clinically relevant increase in cyclosporine or tacrolimus blood concentration at 2 weeks. This measurement will be dropped if all cases of clinically relevant drug interactions manifest at 1 week in the first 20 enrolled participants.
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Timepoint [8]
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2 weeks
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Primary outcome [9]
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Serious adverse events
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Assessment method [9]
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Descriptive tabulation (preliminary safety)
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Timepoint [9]
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1 year
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Secondary outcome [1]
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Feasibility of recruiting for neurocognitive substudy
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Assessment method [1]
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Proportion of enrolled participants who consent to participate in the neurocognitive substudy
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Timepoint [1]
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1 year
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Secondary outcome [2]
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Baseline prevalence of cognitive impairment (substudy)
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Assessment method [2]
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Montreal Cognitive Assessment (MoCA) score \<26, scored out of 30.
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Timepoint [2]
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1 year
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Secondary outcome [3]
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Pooled standard deviation of MoCA test scores (substudy)
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Assessment method [3]
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Montreal Cognitive Assessment (MoCA), raw scores are scored out of 30, with a higher score representing better cognitive function
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Timepoint [3]
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1 year
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Secondary outcome [4]
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Pooled standard deviation of Hopkins Verbal Learning Test - Revised scores (substudy)
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Assessment method [4]
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Hopkins Verbal Learning Test - Revised, a memory test scored out of 60, with a higher score representing better memory
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Timepoint [4]
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1 year
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Secondary outcome [5]
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Pooled standard deviation of Trail Making A and B test scores (substudy)
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Assessment method [5]
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Trail Making A and B, a visual attention test. This records the time (in seconds) to completion, with a faster time representing better cognitive function
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Timepoint [5]
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1 year
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Secondary outcome [6]
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Pooled standard deviation of Controlled Oral Word Association test scores (substudy)
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Assessment method [6]
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Controlled Oral Word Association, a verbal fluency test, measures the production of words belonging to the same letter. This records total number of words produced, with a higher number representing better verbal fluency.
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Timepoint [6]
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1 year
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Secondary outcome [7]
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Pooled standard deviation of Animal Naming Task scores (substudy)
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Assessment method [7]
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Animal Naming Task, a verbal fluency task, measures the total number of animals named in one minute, with a higher number representing better verbal fluency
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Timepoint [7]
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1 year
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Secondary outcome [8]
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Pooled standard deviation of cognitive test scores (substudy)
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Assessment method [8]
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Wechsler Adult Intelligence Scale - Revised, Digit Span subtest, a number sequencing memory test, measures the number of correctly repeated sequences with maximum score of 48. The higher score represents better cognitive function
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Timepoint [8]
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1 year
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Secondary outcome [9]
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Pooled standard deviation of serum phosphate levels (substudy)
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Assessment method [9]
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Timepoint [9]
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1 year
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Eligibility
Key inclusion criteria
1. Age = 18 years old
2. Kidney, liver, heart, or lung transplant at least two years ago
3. History of at least one prior histologically-confirmed keratinocyte carcinoma or squamous cell carcinoma in situ
4. Currently immunosuppressed with a calcineurin inhibitor-based regimen (cyclosporine or tacrolimus)
5. Able to attend follow-up visits
6. Able to speak and understand English (only for cognitive substudy)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Use of mTOR inhibitor (sirolimus, everolimus) within the past 12 weeks
2. Biopsy-confirmed acute rejection episode within the past 12 weeks
3. Active liver disease (elevated AST or ALT >3 times normal)
4. Severe renal failure (estimated glomerular filtration rate <20 mL/min/1.73 m2)
5. Current carbamazepine or primidone use
6. Pregnancy and lactation
7. Gorlin syndrome or other genetic skin cancer syndrome
8. Solid organ or hematologic malignancy, invasive Stage II melanoma, Merkel cell carcinoma, or metastatic skin cancer within the past five years, or invasive Stage I melanoma within the past two years
9. Untreated localized skin cancer (invasive squamous cell carcinoma, basal cell carcinoma, or keratoacanthoma) at baseline (the patient can enrol after skin cancer treatment)
10. Use of nicotinamide or niacin (250 mg or more daily) within the past 12 weeks
11. Use of field therapy for actinic keratoses within the past 12 weeks
12. Initiation of systemic chemoprevention within the past 12 weeks
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/12/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2023
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Actual
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Sample size
Target
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Accrual to date
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Final
120
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Funding & Sponsors
Primary sponsor type
Other
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Name
Women's College Hospital
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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The Kidney Foundation of Canada
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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NOW Foods
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Natural Life Nutrition
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
A common long-term side effect of anti-rejection (immunosuppressant) medications is skin cancer. This pilot clinical trial evaluates the feasibility of conducting a larger pivotal trial to examine the efficacy and safety of nicotinamide for prevention of keratinocyte carcinoma in solid organ transplant recipients. This pilot trial will transition into the pivotal trial if all feasibility targets are met.
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Trial website
https://clinicaltrials.gov/study/NCT03769285
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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An-Wen Chan, MD DPhil
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Address
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Women's College Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
If feasibility thresholds are met, this pilot trial will proceed to a larger pivotal trial. The study protocol for the pivotal trial will be published prior to completion of data collection. Beyond 2 years after completion of the pivotal trial, the cleaned, anonymized, participant-level dataset and statistical code will made available for sharing with external researchers upon approval of a study proposal describing the intended data usage.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Analytic code
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When will data be available (start and end dates)?
2 years after completion of the pivotal trial that follows this pilot trial
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03769285
Download to PDF