Transplant Trial Watch

Assessment of Tacrolimus Intra-patient Variability in Stable Adherent Transplant Recipients: Establishing Baseline Values.

Leino, A. D., King, E. C. et al. (2018).

American Journal of Transplantation;19(5):1410-1420

To identify the intrapatient variability of tacrolimus in adherent transplant recipients.

Secondary, post-hoc analysis of 3 different formulations of tacrolimus, each for two 1‐week periods.

42 individuals with a kidney and 40 with a liver transplant were consented and randomised to a treatment sequence.

Outcomes were measured as tacrolimus adherence, tacrolimus trough levels (C0) and tacrolimus variability.

6 weeks.

CET Conclusions
This manuscript reports the post-hoc analysis of a randomized controlled trial comparing different tacrolimus formulations, investigating baseline tacrolimus intrapatient variability (IPV). The authors find a median IPV of 15.2% in this very adherent population, with no differences seen between formulation or transplant organ. They also demonstrate feasibility of home tacrolimus monitoring using dried blood spot technology. These data set a useful baseline for IPV in an adherent population. As adherence was over 99% in all groups, the effect of poor adherence on IPV could not be ascertained. It should be noted that IPV measurements were taken from daily samples over a 7-day dosing period, which is not typical of the longer-periods over which measurements would be taken in a real-world clinical setting.

Jadad score

Data analysis
Modified intention-to-treat analysis

Allocation concealment

Trial registration - NCT01889758

Funding source
Non-industry funded