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Tacrolimus and Mycophenolic Acid Therapeutic Exposure Targets in Black and White Kidney Transplant Recipients

K. Tornatore1, K. Attwood1, S. Chang1, A. Gundroo2, B. Murray1

1Univeristy at Buffalo/SUNY, Buffalo, NY, 2Ohio State Medical Center, Columbus, OH

Meeting: 2022 American Transplant Congress

Abstract number: 534

Keywords: Area-under-curve (AUC), Immunosuppression, Kidney transplantation

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: 6:50pm-7:00pm

Location: Hynes Room 311

*Purpose: Tacrolimus and Mycophenolic Acid(MPA), the preferred immunosuppressive regimen for kidney transplant recipients(KTR), exhibit interpatient pharmacokinetic variability which may impact allograft survival in Black and White recipients. Racial investigations of tacrolimus and MPA troughs with corresponding area under concentration-time curves(AUC0-12hr) are limited. The relationship between tacrolimus and MPA troughs to corresponding therapeutic AUC0-12hr targets is investigated in 67 stable Black and White KTR.

*Methods: During an open-label, single center pharmacology study in 35 Black and 32 White stable KTR, 12-hour serial samples determined steady-state tacrolimus and MPA AUC0-12 and troughs(C-0hr). Data was analyzed using Mann-Whitney U and Fishers Exact tests by SAS V 9.4.

*Results: Table 1 summarizes the results by race. Although 98.5% of KTR achieved therapeutic tacrolimus troughs, 20.9% of patients had AUC0-12 less than target 100ng▪h/ml. 82.9% Black KTR achieved the target tacrolimus AUC0-12 compared to 68.8% of Whites(P=0.053). Suggested MPA trough range was exceeded in 32.5% of KRT with 56.7% of recipients achieving MPA AUC0-12hr greater than 60 mg●h/L. Less than 28% of all KTR achieved AUC0-12 targets for tacrolimus and MPA AUC0-12.

*Conclusions: Therapeutic AUC0-12 targets for tacrolimus and MPA are not consistently achieved in stable Black and White KTR during maintenance immunosuppression. Troughs do not consistently correlate with tacrolimus or MPA AUC0-12. Additional pharmacologic factors must be investigated.

Table Summary
†=Mean±SD Blacks [N=35] Whites[N=32] P-Value
Tacrolimus (TAC) Dose(mg)† 4.2±1.8 2.4±1.0 <0.001
TAC C-0hr(ng/ml)† 7.2±1.9 6.4±1.5 0.099
TAC AUC0-12hr † 135.2±33.1 114.6±28.0 0.009
TAC AUC0-12hr at target:100-190 mg▪hr/ml 29(82.9%) 22(68.9%) 0.053
MPA C-0hr mg/L 4.9±3.7 4.5±5.5 0.194
MPA AUC0-12hr †   72.1±31.4 65.4±30.3 0.376
MPA AUC0-12hr at target 30 to 60 mg●h/L 10(28.6%) 13(40.6%) 0.539

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To cite this abstract in AMA style:

Tornatore K, Attwood K, Chang S, Gundroo A, Murray B. Tacrolimus and Mycophenolic Acid Therapeutic Exposure Targets in Black and White Kidney Transplant Recipients [abstract]. Am J Transplant. 2022; 22 (suppl 3). https://atcmeetingabstracts.com/abstract/tacrolimus-and-mycophenolic-acid-therapeutic-exposure-targets-in-black-and-white-kidney-transplant-recipients/. Accessed May 11, 2025.

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