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Oral Nicotinamide for Actinic Keratosis Prevention in Kidney Transplant Recipients: A Pilot Double-Blind, Randomized,
Helen Zhang1, Elisabeth A George-Washburn2, Kimberly B Hashemi3
1The Warren Alpert Medical School of Brown University, Providence, RI.
Background:
Oral nicotinamide (NAM) has shown promise in preventing actinic keratoses (AKs) in trials based outside of the United States. We assessed the efficacy of oral NAM supplementation in kidney transplant recipients with a history of keratinocyte carcinoma.
Material And Methods:
Patients enrolled in a 2-week run-in phase, during which NAM 1000 mg was taken twice daily. After a washout period, patients who tolerated the run-in phase were randomized to NAM 500 mg twice daily or placebo. At baseline, 4, 8, and 12 months, dermatologists conducted full-body skin exams to document area-specific AKs. Routine lab work was collected to ensure the stability of renal allograft function.
Results:
The dosage was reduced from 1000 to 500 mg due to gastrointestinal symptoms in the run-in phase. Patients were randomized to NAM (n = 10) or placebo (n = 11). At 12 months, mean AK count was 30.8 (95% CI -11.7-73.4) for NAM and 26.6 (95% CI 10.8-42.5) for placebo. The difference in percent AK count change at 12 months compared with baseline was 259.8% (95% CI -385.9 to 905.5) for NAM and 72.4% (95% CI -118.6 to 263.5) for placebo. The between-group difference in percent AK change was not significant (P = .38). There was no attrition in the placebo group and 40% attrition in the NAM arm.
Discussion:
Nicotinamide did not decrease AK development among kidney transplant recipients. Limitations include drug tolerability, small sample size, and single-center trial nature.
Insights
Oral nicotinamide (NAM) did not prevent actinic keratoses (AKs) in kidney transplant recipients. Gastrointestinal side effects and high attrition limited the study
Area of Science:
- Dermatology
- Nephrology
- Pharmacology
Background:
- Actinic keratoses (AKs) are common in kidney transplant recipients.
- Oral nicotinamide (NAM) has shown potential in preventing AKs in other populations.
- This study investigated NAM efficacy in kidney transplant recipients with a history of keratinocyte carcinoma.
Purpose of the Study:
- To assess the efficacy of oral NAM supplementation in preventing AKs in kidney transplant recipients.
- To evaluate the safety and tolerability of oral NAM in this patient group.
Main Methods:
- A 2-week run-in phase with 1000 mg NAM twice daily, followed by randomization to 500 mg NAM twice daily or placebo.
- Full-body skin exams were conducted at baseline and at 4, 8, and 12 months.
- Renal allograft function was monitored via routine lab work.
Main Results:
- The dosage was reduced to 500 mg due to gastrointestinal symptoms.
- Mean AK count at 12 months was 30.8 for NAM (n=10) and 26.6 for placebo (n=11).
- No significant difference in AK count change was observed between groups (P=.38), with 40% attrition in the NAM arm.
Conclusions:
- Oral NAM supplementation did not decrease AK development in kidney transplant recipients.
- Drug tolerability, small sample size, and single-center design were noted limitations.
- Further research may be needed to explore NAM's role in this population.
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