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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| The Kidney Foundation of Canada | OTHER |
| NOW Foods | OTHER |
| Natural Life Nutrition |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotinamide | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide | Drug | Oral nicotinamide (500 mg) twice daily for at least 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (pertaining to patient recruitment) | Proportion of patients who consent to data linkage to provincial administrative databases | 1 year |
| Feasibility (pertaining to appropriateness of eligibility criteria) | Reasons for exclusion of screened patients | 1 year |
| Feasibility (pertaining to adherence to intervention) | Proportion of capsules returned, reasons for non-adherence | 1 year |
| Feasibility (pertaining to adherence to follow-up assessments) | Proportion of missed assessments and incomplete questionnaire data variables, proportion of patients who withdraw from the trial, patient perception of trial participation | 1 year |
| Feasibility (pertaining to data linkage) | Proportion of patients who consent to data linkage to provincial administrative databases | 1 year |
| Preliminary pooled keratinocyte carcinoma event rate | Pooled keratinocyte carcinoma event rate to be used for sample size re-estimation in the pivotal trial. | 1 year |
| Drug interactions | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of recruiting for neurocognitive substudy | Proportion of enrolled participants who consent to participate in the neurocognitive substudy | 1 year |
| Baseline prevalence of cognitive impairment (substudy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| An-Wen Chan, MD DPhil | Women's College Hospital | Principal Investigator |
| Joseph Kim, MD PhD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital, University Health Network | Toronto | Ontario | M5G 2N2 | Canada |
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.
2 years after completion of the pivotal trial that follows this pilot trial
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| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| UNKNOWN |
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| Placebo oral capsule | Drug | Matching placebo taken twice daily for at least 52 weeks |
|
| 1 week |
| Drug interactions | 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. | 2 weeks |
| Serious adverse events | Descriptive tabulation (preliminary safety) | 1 year |
Montreal Cognitive Assessment (MoCA) score <26, scored out of 30.
| 1 year |
| Pooled standard deviation of MoCA test scores (substudy) | Montreal Cognitive Assessment (MoCA), raw scores are scored out of 30, with a higher score representing better cognitive function | 1 year |
| Pooled standard deviation of Hopkins Verbal Learning Test - Revised scores (substudy) | Hopkins Verbal Learning Test - Revised, a memory test scored out of 60, with a higher score representing better memory | 1 year |
| Pooled standard deviation of Trail Making A and B test scores (substudy) | 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 | 1 year |
| Pooled standard deviation of Controlled Oral Word Association test scores (substudy) | 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. | 1 year |
| Pooled standard deviation of Animal Naming Task scores (substudy) | 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 | 1 year |
| Pooled standard deviation of cognitive test scores (substudy) | 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 | 1 year |
| Pooled standard deviation of serum phosphate levels (substudy) | 1 year |
| D018307 |
| Neoplasms, Squamous Cell |
| D018295 | Neoplasms, Basal Cell |
| D006573 |
| Heterocyclic Compounds, 1-Ring |