Actinic KeratosesEarly Phase 1NICENCT04843553
Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients
A Early Phase 1 study testing Oral Nicotinamide in people with Actinic Keratoses, run by Rhode Island Hospital.
Trial summary
Skin cancers and pre-cancerous growths (called actinic keratoses, "AKs"), that aren't melanomas, develop in patients with a kidney transplant at excessive rates. When these pre-cancerous AKs, and "non-melanoma" skin cancers occur in kidney transplant patients, they tend to be aggressive, and require frequent medical… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Oral Nicotinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 14 Oct 2016to 18 Dec 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Kidney transplant ≥ 12-months ago
- ongoing, standard immunosuppression regimen
- current CKD
- EPI estimated (43)
- glomerular filtration rate (eGFR) ≥ 15 ml/min per 1.73 m2)
- Prior history of at least one NMSC
Who cannot join
- Kidney transplant <12-months ago, treatment for acute rejection <= 3-months ago, or current eGFR< 20
- Known history of active liver disease/ transaminitis [alanine aminotransferase, ALT > 1.5 X upper limit of normal]
- Serum phosphorus < 2.0 mg/dL or average ≤ 100 × 10(9)/mL platelets
- Internal malignancy, metastatic SCC, or invasive melanoma within the past 5-years
- Overwhelming numbers of current skin cancers or large areas of confluent skin cancer at baseline preventing accurate assessment and counting of new skin cancers
- Field treatment for AKs within the past 4-weeks, preventing accurate assessment of AKs
Show all 11Show fewer
- Patients begun on acitretin or other oral retinoids, or mTOR inhibitors within the past 6-months (If stably taking for more than six months, they may participate)
- Gorlin's syndrome or other genetic skin cancer syndrome
- Patients unavailable for follow-up for the duration of the study because of social/ geographical reasons, or general frailty
- Pregnancy or lactation (all women of childbearing will be required to use contraception throughout the study)
- Patients taking supplemental NAM within the past 4-weeks
About this study
Official title: Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients: A Pilot Study
Skin cancers and pre-cancerous growths (called actinic keratoses, "AKs"), that aren't melanomas, develop in patients with a kidney transplant at excessive rates. When these pre-cancerous AKs, and "non-melanoma" skin cancers occur in kidney transplant patients, they tend to be aggressive, and require frequent medical procedures, often surgery, for the removal of the skin cancers. If not removed adequately the pre-cancers can develop into skin cancers, and the skin cancers, if not removed, may spread, and even cause death. Reducing the occurrence and complications of these skin cancers and pre-cancers in kidney transplant patients with a safe, effective, well-tolerated treatment taken by mouth would be an important medical advance.
We are testing oral nicotinamide (NAM)-a B-vitamin compound-for that purpose. Approximately fifty kidney transplant patients who have had at least one non-melanoma skin cancer in the past, will be given randomized to receive NAM, 1 gram twice daily by mouth, or identical pills without NAM, and followed for 1 year to see if NAM treatment reduces the numbers of pre-cancerous AKs, and non-melanoma skin cancers they develop. Patients will be asked to come to the clinic for 3 follow up visits (every 4 months for up to 12 months). They will receive a full body skin exam by a dermatologist, have detailed counting of AKs and biopsies for any suspicious lesions as standard of care. Blood will also be drawn as well as a urine sample obtained at each visit for safety assessment and storage. We will also ask them to answer a series of questions about dietary patterns and intake of whole foods and supplements.
Read the detailed description
Non-melanoma cutaneous carcinomas [NMSCs], predominantly squamous cell carcinomas [SCCs], as well as basal cell carcinomas [BCCs], are the most common malignancies occurring in kidney transplant recipients [KTRs]. SCCs and BCCs, account for more than 90% of NMSCs in KTRs. New NMSCs in KTRs with a prior NMSC develop at 3-times the rate reported in non-KTRs with the same clinical history. The unique aggressiveness of SCCs in KTRs increases patient morbidity, due to the high rate of new lesions requiring treatment, frequently surgical excision. This non-fatal morbidity also results in significant medical costs. KTR SCCs have a greater potential for metastasis, and death. Reduction in the incidence and complications associated with SCCs, in particular, and more generally, overall NMSCs, as well as Actinic Keratoses, would mark a significant advance in the management of KTRs.
Specific Aims of this study are: To evaluate the effects of oral nicotinamide 2 grams/day, given in two divided doses, for 12-months, versus matched placebo, on the total number of actinic keratoses which develop in stable chronic kidney transplant recipients with a history of at least one non-melanoma skin cancer; To demonstrate our ability to create a system for diagnosing, capturing, and recording all new non-melanoma skin cancers which develop in stable chronic kidney transplant recipients with a history of at least one non-melanoma skin cancer while receiving oral nicotinamide 2 grams/day, given in two divided doses, for 12-months, versus matched placebo; To evaluate the effects of oral nicotinamide 2 grams/day, given in two divided doses, for 12-months, versus matched placebo, on sirtuin enzymatic activity in chronic kidney transplant recipients with a history of at least one non-melanoma skin cancer; To evaluate the safety and tolerability of oral nicotinamide 2 grams/day, given in two divided doses, for 12-months, versus matched placebo, in stable chronic kidney transplant recipients with a history of at least one non-melanoma skin cancer; To evaluate the effects of oral nicotinamide 2 grams/day, given in two divided doses, for 12-months, versus matched placebo, on serum phosphorus concentrations in stable chronic kidney transplant recipients with a history of at least one non-melanoma skin cancer.
- Conditions
- Actinic Keratoses
- Being tested
- Oral Nicotinamide
- Keywords
- Nicotinamide, AKs
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral NicotinamideDrug
Also called Vitamin B-3
| Study group | Role | What they receive |
|---|---|---|
| active | Active comparator | Participants receiving oral vitamin B-3 Receives: Drug: Oral Nicotinamide |
| placebo | Placebo comparator | Participants receiving oral inactive pill Receives: Drug: Oral Nicotinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of oral nicotinamide on AKs
To evaluate the effects of oral nicotinamide 1gram/day, given in two divided doses, for 9- 12-months, versus matched placebo, on the total number of actinic keratoses which develop in stable chronic kidney transplant recipients with a history of at least one non-melanoma skin cancer (keratinocyte carcinoma).
To evaluate the effects of oral nicotinamide 1gram/day, given in two divided doses, for 9- 12-months, versus matched placebo, on the total number of actinic keratoses which develop in stable chronic kidney transplant recipients with a history of at least one non-melanoma skin cancer (keratinocyte carcinoma).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start14 Oct 2016
- Primary completion8 Feb 2019
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reginald m Gohh, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843553
- Sponsor's protocol ID
- Rhode islandHospital
- Acronym
- NICE
- Status last verified
- Mar 2021
- First submitted
- 12 Apr 2021
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rogers HW, Weinstock MA, Feldman SR, Coldiron BM. Incidence Estimate of Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the U.S. Population, 2012. JAMA Dermatol. 2015 Oct;151(10):1081-6. doi: 10.1001/jamadermatol.2015.1187.
PubMed 25928283Hartevelt MM, Bavinck JN, Kootte AM, Vermeer BJ, Vandenbroucke JP. Incidence of skin cancer after renal transplantation in The Netherlands. Transplantation. 1990 Mar;49(3):506-9. doi: 10.1097/00007890-199003000-00006.
PubMed 2316011Webb MC, Compton F, Andrews PA, Koffman CG. Skin tumours posttransplantation: a retrospective analysis of 28 years' experience at a single centre. Transplant Proc. 1997 Feb-Mar;29(1-2):828-30. doi: 10.1016/s0041-1345(96)00152-2. No abstract available.
PubMed 9123544
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients: A Pilot Study
- ClinicalTrials.gov ID
- NCT04843553
- Acronym / sponsor ID
- NICE / Rhode islandHospital
- Conditions
- Actinic Keratoses
- Keywords
- Nicotinamide, AKs
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Skin cancers and pre-cancerous growths (called actinic keratoses, "AKs"), that aren't melanomas, develop in patients with a kidney transplant at excessive rates. When these pre-cancerous AKs, and "non-melanoma" skin cancers occur in kidney transplant patients, they tend to be aggressive, and require frequent medical procedures, often surgery, for the removal of the skin cancers. If not removed adequately the pre-cancers can develop into skin cancers, and the skin cancers, if not removed, may spread, and even cause death. Reducing the occurrence and complications of these skin cancers and pre-cancers in kidney transplant patients with a safe, effective, well-tolerated treatment taken by mouth would be an important medical advance.
We are testing oral nicotinamide (NAM)-a B-vitamin compound-for that purpose. Approximately fifty kidney transplant patients who have had at least one non-melanoma skin cancer in the past, will be given randomized to receive NAM, 1 gram twice daily by mouth, or identical pills without NAM, and followed for 1 year to see if NAM treatment reduces the numbers of pre-cancerous AKs, and non-melanoma skin cancers they develop. Patients will be asked to come to the clinic for 3 follow up visits (every 4 months for up to 12 months). They will receive a full body skin exam by a dermatologist, have detailed counting of AKs and biopsies for any suspicious lesions as standard of care. Blood will also be drawn as well as a urine sample obtained at each visit for safety assessment and storage. We will also ask them to answer a series of questions about dietary patterns and intake of whole foods and supplements.
Detailed description
Non-melanoma cutaneous carcinomas [NMSCs], predominantly squamous cell carcinomas [SCCs], as well as basal cell carcinomas [BCCs], are the most common malignancies occurring in kidney transplant recipients [KTRs]. SCCs and BCCs, account for more than 90% of NMSCs in KTRs. New NMSCs in KTRs with a prior NMSC develop at 3-times the rate reported in non-KTRs with the same clinical history. The unique aggressiveness of SCCs in KTRs increases patient morbidity, due to the high rate of new lesions requiring treatment, frequently surgical excision. This non-fatal morbidity also results in significant medical costs. KTR SCCs have a greater potential for metastasis, and death. Reduction in the incidence and complications associated with SCCs, in particular, and more generally, overall NMSCs, as well as Actinic Keratoses, would mark a significant advance in the management of KTRs.
Specific Aims of this study are: To evaluate the effects of oral nicotinamide 2 grams/day, given in two divided doses, for 12-months, versus matched placebo, on the total number of actinic keratoses which develop in stable chronic kidney transplant recipients with a history of at least one non-melanoma skin cancer; To demonstrate our ability to create a system for diagnosing, capturing, and recording all new non-melanoma skin cancers which develop in stable chronic kidney transplant recipients with a history of at least one non-melanoma skin cancer while receiving oral nicotinamide 2 grams/day, given in two divided doses, for 12-months, versus matched placebo; To evaluate the effects of oral nicotinamide 2 grams/day, given in two divided doses, for 12-months, versus matched placebo, on sirtuin enzymatic activity in chronic kidney transplant recipients with a history of at least one non-melanoma skin cancer; To evaluate the safety and tolerability of oral nicotinamide 2 grams/day, given in two divided doses, for 12-months, versus matched placebo, in stable chronic kidney transplant recipients with a history of at least one non-melanoma skin cancer; To evaluate the effects of oral nicotinamide 2 grams/day, given in two divided doses, for 12-months, versus matched placebo, on serum phosphorus concentrations in stable chronic kidney transplant recipients with a history of at least one non-melanoma skin cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active | Active comparator | Drug: Oral NicotinamideParticipants receiving oral vitamin B-3 |
| placebo | Placebo comparator | Drug: Oral NicotinamideParticipants receiving oral inactive pill |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Kidney transplant ≥ 12-months ago
- ongoing, standard immunosuppression regimen
- current CKD
- EPI estimated (43)
- glomerular filtration rate (eGFR) ≥ 15 ml/min per 1.73 m2)
Key exclusion criteria (11 listed)
- Kidney transplant <12-months ago, treatment for acute rejection <= 3-months ago, or current eGFR< 20
- Known history of active liver disease/ transaminitis [alanine aminotransferase, ALT > 1.5 X upper limit of normal]
- Serum phosphorus < 2.0 mg/dL or average ≤ 100 × 10(9)/mL platelets
- Internal malignancy, metastatic SCC, or invasive melanoma within the past 5-years
- Overwhelming numbers of current skin cancers or large areas of confluent skin cancer at baseline preventing accurate assessment and counting of new skin cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral NicotinamideAlso: Vitamin B-3 | Drug | active, placebo |
Primary outcome
Effects of oral nicotinamide on AKs
Time frame: 12 months
To evaluate the effects of oral nicotinamide 1gram/day, given in two divided doses, for 9- 12-months, versus matched placebo, on the total number of actinic keratoses which develop in stable chronic kidney transplant recipients with a history of at least one non-melanoma skin cancer (keratinocyte carcinoma). To evaluate the effects of oral nicotinamide 1gram/day, given in two divided doses, for 9- 12-months, versus matched placebo, on the total number of actinic keratoses which develop in stable chronic kidney transplant recipients with a history of at least one non-melanoma skin cancer (keratinocyte carcinoma).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Background: PubMed 25928283Rogers HW, Weinstock MA, Feldman SR, Coldiron BM. Incidence Estimate of Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the U.S. Population, 2012. JAMA Dermatol. 2015 Oct;151(10):1081-6. doi: 10.1001/jamadermatol.2015.1187.
- Background: PubMed 2316011Hartevelt MM, Bavinck JN, Kootte AM, Vermeer BJ, Vandenbroucke JP. Incidence of skin cancer after renal transplantation in The Netherlands. Transplantation. 1990 Mar;49(3):506-9. doi: 10.1097/00007890-199003000-00006.
- Background: PubMed 9123544Webb MC, Compton F, Andrews PA, Koffman CG. Skin tumours posttransplantation: a retrospective analysis of 28 years' experience at a single centre. Transplant Proc. 1997 Feb-Mar;29(1-2):828-30. doi: 10.1016/s0041-1345(96)00152-2. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reginald m Gohh principal investigator
Rhode Island Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oral Nicotinamide in people with Actinic Keratoses, run by Rhode Island Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of oral nicotinamide on AKs (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04843553, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.