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Tacrolimus Exposure Estimation in Stable Kidney Transplant Recipients Using Maximum A Posteriori Bayesian Approach

T. Nguyen1, N. M. Smith1, K. Attwood2, B. Murray3, K. Tornatore-Morse1

1University at Buffalo School of Pharmacy and Pharmaceutical Sciences, Buffalo, NY, 2School of Public Health
University at Buffalo, Buffalo, NY, 3Erie County Medical Center
School of Medicine/UB, Buffalo, NY

Meeting: 2022 American Transplant Congress

Abstract number: 527

Keywords: Immunosuppression, Kidney transplantation, Pharmacokinetics

Topic: Clinical Science » Pharmacy » 29 - Non-Organ Specific: Pharmacokinetics / Pharmacogenomics / Drug interactions

Session Information

Session Name: Non-Organ Specific: Pharmacokinetics / Pharmacogenomics / Drug interactions

Session Type: Rapid Fire Oral Abstract

Date: Tuesday, June 7, 2022

Session Time: 5:30pm-7:00pm

 Presentation Time: 5:40pm-5:50pm

Location: Hynes Room 311

*Purpose: Tacrolimus exhibits interpatient pharmacokinetic variability that impacts clinical responses and requires routine trough therapeutic drug monitoring. Tacrolimus troughs do not consistently predict area under concentration-time curves 0 to 12 hours(AUC0-12hr) which quantitates therapeutic exposure. To investigate this issue, tacrolimus AUC0-12hr determined by Non-Compartmental Analysis(NCA) was compared to Robust(9-timed samples) and Sparse (2-timed samples) AUC0-12hr estimates using Maximum a Posteriori-Bayesian (MAP) Approach in 67 stable KTR.

*Methods: During an open-label single center pharmacology study, 12-hour serial samples were collected to determine steady-state tacrolimus AUC0-12hr using standard NCA. Robust (9-timed samples) and Sparse (trough and 8-hour samples) generated AUC0-12hr estimates by MAP Approach using the Advanced Dosing Solutions Program (ADAPT v5) . AUC0-12hr comparisons were made by paired T-tests with intraclass correlation coefficient(ICC) providing level of agreement between AUC0-12hr estimates using SAS V9.4. Bland Altman plots compared AUC0-12hr data.

*Results: 35 Black and 32 White stable KTR(e-GFR=57.1±15.7ml/min/1.73m2) received tacrolimus dose of 3.4±1.7 mg/study with troughs=6.8 ±1.7 ng/ml. The group NCA-AUC0-12hr was 123.8±33.7 ng∙hr/ml compared to MAP estimates for Robust-AUC0-12hr =130.2±32.8 ng∙hr/ml and Sparse-AUC0-12hr of 126.5±33.0 ng∙hr/ml. Summary Table compares tacrolimus AUC0-12hr with the ICC supporting correlations for MAP- Robust and Sparse estimates to measured NCA for AUC0-12hr.

*Conclusions: Use of MAP estimation from sparse sampling and trough monitoring post-transplant provides an approach to quantitate tacrolimus AUC0-12hr .

Table Summary

AUC0-12hr    Comparisons

Mean Difference (Standard Deviation) P-value ICC
Robust vs NCA  6.43(13.2) 0.001 0.90
Sparse vs NCA 2.71(22.1) 0.320 0.78
Robust vs Sparse   3.73(11.6) 0.011 0.93

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To cite this abstract in AMA style:

Nguyen T, Smith NM, Attwood K, Murray B, Tornatore-Morse K. Tacrolimus Exposure Estimation in Stable Kidney Transplant Recipients Using Maximum A Posteriori Bayesian Approach [abstract]. Am J Transplant. 2022; 22 (suppl 3). https://atcmeetingabstracts.com/abstract/tacrolimus-exposure-estimation-in-stable-kidney-transplant-recipients-using-maximum-a-posteriori-bayesian-approach/. Accessed May 28, 2025.

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