Transplant Trial Watch

A randomized, open-label pharmacokinetic trial of tacrolimus extended-release dosing in obese de novo kidney transplant recipients.

Jasiak-Panek, N. M., Wenzler, E. et al. (2019).

Clinical Transplantation; [record in progress].

This study aimed to assess the pharmacokinetics of tacrolimus extended-release (TAC-ER) in obese renal transplant recipients after dosing based on ideal body weight (IBW) to total body weight (TBW).

Patients were randomized to receive TAC‐ER at a dose of 0.15 mg/kg daily in the morning based on either ideal body weight (n=10) or adjusted body weight (n=10).

Adult obese de novo renal transplant recipients (n=20).

The primary outcome was of this study was measured as the difference in TAC‐ER exposure (AUC0‐24) in obese patients who received an initial TAC‐ER dose of 0.15 mg/kg using aBW versus IBW. The secondary endpoint was the difference in the time to reach a therapeutic trough level in aBW group compared with IBW.

14 days

CET Conclusions
The pilot, open-label, randomised controlled trial compared plasma pharmacokinetics of tacrolimus extended release (TAC-ER) in obese (body mass index of ≥30 kg/m2) de novo adult kidney transplant recipients after dosing based on either adjusted body weight versus ideal body weight. The method of generating the randomisation sequence and whether allocation was concealed was not described. The pharmacokinetic assessments were conducted on three separate days (days 1, 7 and 14). As this was a pilot study no sample size calculation was conducted. A total sample size of 20 participants was considered sufficient to generate descriptive data. The two groups were balanced for the baseline characteristics except for age with the ideal body weight group being on average 12 years older. There was no statistically significant difference in the primary outcome TAC‐ER exposure (AUC0‐24) between groups on any of the three days. The safety did also not reveal any differences between groups. These pilot data need to be confirmed in a adequately powered study.

Jadad score

Data analysis
Strict intention-to-treat analysis

Allocation concealment

Trial registration - NCT02444143

Funding source
Industry funded