Transplant Trial Watch

Increasing Time in Therapeutic Range of Tacrolimus in the First Year Predicts Better Outcomes in Living-Donor Kidney Transplantation.

Song, T. et al.

Frontiers in Immunology [record in progress].

The primary objective of this study was to examine the effects of time in therapeutic range (TTR) of tacrolimus on long term outcomes among living-related renal transplant recipients.

Participants were randomized in a 2:1 ratio to either the development or the validation cohort.

1241 renal transplant recipients were included.

The outcomes of interest were graft loss, patient death, acute rejection (AR) and infection.

Median 42 months [Interquartile Range (IQR): 26–59 months]

CET Conclusions
This single-centre retrospective study investigates the impact of time-in-therapeutic range (TTR) for tacrolimus on outcomes in renal transplant recipients. The study team randomly divided their set of 1,241 patients into study and validation cohorts and found that a TTR of less than 78% is associated with inferior graft and patient survival and higher rates of infection and acute rejection. They report that TTR outperforms other measures including mean tacrolimus level and intrapatient variability (IPV). These data are interesting, and point to TTR as a potentially useful surrogate marker in clinical trials targeting improved adherence or stability in RTR. Whether it is useful as a prospective monitoring tool to identify at-risk recipients needs further investigation, and these findings would need to be validated in other cohorts with different mixes of deceased and living donor transplants and different tacrolimus target ranges.

Trial registration

Funding source
Non-industry funded