Nicotinamide for Preventing Skin Cancer in Transplant Patients
Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
Recruiting
Phase 3
Interventional Study
Non-melanoma Skin Cancer
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Keratinocyte Carcinoma
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 396 (estimated)
- Sponsor
- Women's College Hospital · Other
Who this trial is looking for
This trial is looking for adults who have received an organ transplant and have had at least one skin cancer. Participants will take nicotinamide pills for up to 4 years to see if it helps prevent new skin cancers.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old
- I had a kidney, liver, heart, or lung transplant at least two years ago
- I have had at least one type of skin cancer confirmed by a doctor
- I am currently taking immunosuppressive medication
- I can come to follow-up visits
You may not be able to join if
- I have used nicotinamide or niacin in the past 12 weeks
- I have untreated skin cancer right now
- I had a kidney transplant rejection in the past 12 weeks
- I have serious liver disease
- I have severe kidney disease
- I have had certain cancers in the past five years
- I am pregnant or breastfeeding
- I am allergic to nicotinamide or the study capsules
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
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…
Trial Locations
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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 (cycl…
Contacts