Session Date & Time: None. Available on demand.
*Purpose: Bodyweight-based tacrolimus dosing followed by therapeutic drug monitoring is standard clinical care after renal transplantation. However, after transplantation, a meagre 38% of patients is on target at first steady state and it can take up to three weeks to reach the target tacrolimus pre-dose concentration (C0). Tacrolimus under- and overexposure is associated with an increased risk of rejection and drug-related toxicity, respectively. To minimize sub- and supra-therapeutic tacrolimus exposure in the immediate post-transplant phase, a previously-developed dosing algorithm to predict an individual’s tacrolimus starting dose was tested prospectively.
*Methods: In this single-arm, prospective, therapeutic intervention trial, 60 de novo kidney transplant recipients received a tacrolimus starting dose based on a dosing algorithm instead of a standard, bodyweight-based dose. The algorithm included cytochrome P450 (CYP) 3A4 and 3A5 genotype, body surface area and age as covariates. The target tacrolimus C0, measured for the first time at day 3, was 7.5-12.5 ng/mL.
*Results: Between 23 February 2019 and 07 July 2020, 60 patients were included. One patient was excluded because of a protocol violation. On day three post-transplantation, 34 out of 59 patients (58%; 90%-CI 47% to 68%) had a tacrolimus C0 within the therapeutic range. Markedly sub-therapeutic (<5.0 ng/mL) and supra-therapeutic (>20 ng/mL) tacrolimus concentrations were observed in 7% and 3% of the patients, respectively. Biopsy-proven acute rejection occurred in three patients (5%).
*Conclusions: Algorithm-based tacrolimus dosing leads to the achievement of the tacrolimus target C0 in as many as 58% of the patients on day three after kidney transplantation.
To cite this abstract in AMA style:Francke MI, Andrews LM, Le HL, Wetering Jvande, Groningen MCClahsen-van, Gelder Tvan, Schaik RHvan, Holt Bvander, Winter BCde, Hesselink DA. Avoiding Tacrolimus Under- and Overexposure with a Dosing Algorithm for Renal Transplant Recipients: A Single Arm Prospective Intervention Trial [abstract]. Am J Transplant. 2021; 21 (suppl 3). https://atcmeetingabstracts.com/abstract/avoiding-tacrolimus-under-and-overexposure-with-a-dosing-algorithm-for-renal-transplant-recipients-a-single-arm-prospective-intervention-trial/. Accessed June 19, 2021.
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