Tacrolimus dosing in liver transplant recipients using phenotypic personalized medicine: A phase 2 randomized clinical trial.
Khong, J., et al.Nature communications 2025; 16(1): 4558.
Aims
The aim of this study was to assess a personalised phenotypic-outcome-guided tacrolimus dosing method immediately following liver transplantation.
Interventions
Participants were randomised to either the Phenotypic Personalized Medicine (PPM) group or the standard-of-care group.
Participants
62 adults undergoing liver transplantation
Outcomes
The primary endpoint was percentage of posttransplant days with greater than 2 ng/mL deviations from the target range, and the incidence of biopsy-proven graft rejection episodes and neurotoxicity.
Follow-up
1 year
CET Conclusions
This single-centre recipient-blinded RCT investigated the role of personalised tacrolimus dosing in the immediate post-transplant period in liver transplant recipients. 62 adult liver recipients were randomised to standard clinician-led dosing, or phenotypic personalized medicine (PPM) dosing based upon calculated response to previous doses. The investigators found that patients undergoing PPM dosing had significantly fewer days with large deviations from the target range. Post-hoc analysis also showed a shorter time to AST recovery associated with shorter hospital stay in the PPM group. The study is well designed, with blinding of recipients and use of a modified intent-to-treat analysis. Randomisation block sizes were fixed which might have affected allocation concealment. The significant clinical differences seen arose in post-hoc exploratory analyses, so should be interpreted with caution. Larger, multicentre studies would be needed to replicate these findings and assess their effect on clinical outcomes, as the current study is underpowered for these.
Data analysis
Modified intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT03527238