Tacrolimus dosing in liver transplant recipients using phenotypic personalized medicine: A phase 2 randomized clinical trial

Jeffrey Khong, Megan Lee, Curtis Warren, Un Bi Kim, Sergio Duarte, Kenneth A. Andreoni, Sunaina Shrestha, Mark W. Johnson, Narendra R. Battula, Danielle M. McKimmy, Thiago Beduschi, Ji-Hyun Lee, Derek M. Li, Chih-Ming Ho and Ali Zarrinpar ()
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Jeffrey Khong: University of California
Megan Lee: University of California
Curtis Warren: University of Florida
Un Bi Kim: University of Florida
Sergio Duarte: University of Florida
Kenneth A. Andreoni: Thomas Jefferson University
Sunaina Shrestha: University of Florida
Mark W. Johnson: University of Florida
Narendra R. Battula: University of Oklahoma
Danielle M. McKimmy: University of Florida
Thiago Beduschi: University of Florida
Ji-Hyun Lee: University of Florida
Derek M. Li: University of Florida
Chih-Ming Ho: University of California
Ali Zarrinpar: University of Florida

Nature Communications, 2025, vol. 16, issue 1, 1-10

Abstract: Abstract Tacrolimus is the most commonly used immunosuppression drug after solid organ transplantation; however, its dosing is challenging due to substantial inter-individual variability, often resulting in blood levels that deviate from the target therapeutic range. We explored whether a dynamically customized, phenotypic-outcome-guided drug dosing method could improve maintenance of drug trough levels within pre-determined target ranges, focusing on tacrolimus immediately after liver transplantation. This single-center, partially blinded, completed clinical trial involved 62 adults undergoing liver transplantation, block randomized into parallel groups: standard-of-care (SOC) clinician-determined or Phenotypic Personalized Medicine (PPM)-guided tacrolimus dosing. The primary outcome was percentage of post-transplant days with large (>2 ng/mL) deviations from the target range. At trial completion, analysis found statistically significant improvement in the PPM group (n = 27): 24.2% of days showing large deviations compared to 38.4% in the SOC group (n = 29) (difference −14.2%, 95% CI: −26.7 to −1.5 %, P = 0.029) with no increase in adverse events. These results demonstrate that PPM-guided tacrolimus dosing more effectively maintains drug levels within the target range compared to SOC, suggesting a promising approach to improving drug dosing. The trial was registered at ClinicalTrials.gov with the identifier NCT03527238.

Date: 2025
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DOI: 10.1038/s41467-025-59739-6

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