Status:
COMPLETED
Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients
Lead Sponsor:
Rhode Island Hospital
Conditions:
Actinic Keratoses
Eligibility:
All Genders
Phase:
EARLY_PHASE1
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 14 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04843553
Start Date
October 14 2016
End Date
December 18 2020
Last Update
April 22 2021
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