Subtherapeutic Low Tacrolimus Trough Levels (≤3.5 Ng /ml) Are A Risk Factor For Acute Rejection And Creatinine Doubling.

J. Arreola Guerra¹, R. Reyes Acevedo², A. Chew Wong¹, F. Haro Alcalde¹, L. Zuñiga Macias¹, R. Delgadillo Castañeda², R. Villafan³

¹Internal Medicine and Nephrology, Centenario Hospital Miguel Hidalgo, Aguascalientes, Mexico, ²Transplantation, Centenario Hospital Miguel Hidalgo, Aguascalientes, Mexico, ³Universidad Autonoma de Aguascalientes, Aguascalientes, Mexico

Meeting: 2019 American Transplant Congress

Abstract number: C65

Keywords: FK506, Graft function, Immunosuppression, Kidney

Session Information

Session Name: Poster Session C: Kidney Complications: Late Graft Failure

Session Type: Poster Session

Date: Monday, June 3, 2019

Session Time: 6:00pm-7:00pm

Presentation Time: 6:00pm-7:00pm

Location: Hall C & D

*Purpose: Tacrolimus (TAC) is part of the immunosuppression scheme of more than 95% of patients after kidney transplantation in Mexico. Low TAC tacrolimus trough levels have been linked to acute rejection and long-term graft dysfunction. In Mexico, since 2005, several generic TAC were introduced, currently having 6 options. In addition to this, the policy of patient supply is based on availability, which causes each patient to change brands up to monthly. The factors and clinical impact related to low levels of TAC (<3.5 ng / ml) in our settings have not been studied.

*Methods: Retrospective cohort study of renal transplant recipients from January 2016 to October 2018.

*Results: 526 patients presented at least one pre-douse determination of TAC, which went to an outpatient clinic. The main cause of CKD was of unknown origin 71.4% (n = 376), followed by DM2 with 8.5% (n = 45) and glomerulonephritis 7.03% (n = 37).

*Conclusions: Low tacrolimus trough levels (<3.5 ng / ml), are related to changes of brands and greater variability of the trough levels. These trough levels are related to acute rejection and short-term creatinine duplication. The policy of TAC supply to patients in Mexico must be revised and avoid the change of brands.

Groups of pts with and w/o TAC < 3.5 ng/ml
Variable	TAC ≤ 3.5 ng/ml (n= 217)	No TAC ≤ 3.5 ng/ml (n=309)	P value
N of brands changes, m (S)	3.2 (3.1)	1.9 (2.3)	<0.001
TAC trough levels, m (S)	6.4 (4.9 – 7.7)	8 (6.4 – 9.3)	<0.001
Standard deviation, med (IQR)	3.06 (2.3 – 4.2)	2.7 (1.7 – 3.8)	0.003
Acute Rejection, n (%)	25 (11.5)	18 (5.8)	0.01
Antibody Med Rejection, n (%)	12 (5.53)	6 (1.94)	0.03
*Doubling creat, n (%)(N= 153/224)**	14 (9.1)*	5 (2.2)*	0.003
Delta Creatinine, m (S)	-0.15 (2.05)	0.55 (2.1)	0.02

To cite this abstract in AMA style:

Guerra JArreola, Acevedo RReyes, Wong AChew, Alcalde FHaro, Macias LZuñiga, Castañeda RDelgadillo, Villafan R. Subtherapeutic Low Tacrolimus Trough Levels (≤3.5 Ng /ml) Are A Risk Factor For Acute Rejection And Creatinine Doubling. [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/subtherapeutic-low-tacrolimus-trough-levels-%e2%89%a43-5-ng-ml-are-a-risk-factor-for-acute-rejection-and-creatinine-doubling/. Accessed May 18, 2025.

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