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].
Aims
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).
Interventions
Patients were randomized to receive TACâ€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).
Participants
Adult obese de novo renal transplant recipients (n=20).
Outcomes
The primary outcome was of this study was measured as the difference in TACâ€ER exposure (AUC0â€24) in obese patients who received an initial TACâ€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.
Follow-up
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 TACâ€ER exposure (AUC0â€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.
Data analysis
Strict intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT02444143