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High Intra-Patient Variability in Tacrolimus Trough Blood Levels Increases the Risk of Death-Censored Graft Loss After Kidney Transplantation

E. Rodrigo,1 D. San Segundo,2 J. Ruiz,1 M. López-Hoyos,2 A. Benito,1 M. de Cos,3 Z. Albines,1 M. Serrano,1 M. Arias.1

1Nephrology, University Hospital Marqués de Valdecilla, Santander, Cantabria, Spain
2Immunology, University Hospital Marqués de Valdecilla, Santander, Cantabria, Spain
3Pharmacology, University Hospital Marqués de Valdecilla, Santander, Cantabria, Spain.

Meeting: 2015 American Transplant Congress

Abstract number: C65

Keywords: Graft survival, Immunosuppression, Kidney transplantation, Renal function

Session Information

Session Name: Poster Session C: Immunosuppression/Compliance

Session Type: Poster Session

Date: Monday, May 4, 2015

Session Time: 5:30pm-6:30pm

 Presentation Time: 5:30pm-6:30pm

Location: Exhibit Hall E

Kidney graft loss rates beyond the first year showed only small improvements over past decades. Advances in maintenance immunosuppressive therapy contributed to the improvements seen in short-term outcomes. A better management of immunosuppressive drugs can also lead to improve long-term outcome. Previous reports related a high variability in tacrolimus trough blood levels with a higher risk for death-censored graft loss (DCGL). Our aim was to analyze the relationship between the intra-patient variability of tacrolimus levels and DCGL and renal function at one-year after kidney transplantation.

The study cohort included 252 deceased-donor kidney transplants performed in our institution between 1997 and 2009, who have survived >1-yr posttransplantation and were on twice-daily tacrolimus-based immunosuppression. Sociodemographic and clinical data were collected from the institutional prospectively maintained database. Coefficient of variation (CV) was defined as the ratio of the standard deviation to the mean of tacrolimus concentration measurements for all outpatient visits within 3-12 months post-transplantation.

Mean follow-up was 6.0 ± 3.2 years. Mean CV was 28.2 ± 16.8%. Some 84 (33.3%) patients showed CV ≥ 30%. Kidney transplant recipients with CV ≥ 30% had significantly worse death-censored graft survival (5-years graft survival 92.9% vs. 75.9%, log-rank p = 0.003). CV ≥ 30% was an independent risk factor for DCGL (HR 2.13, 95%CI 1.16-3.91, p = 0.015) after adjusting by renal function, recipient age, acute rejection and peak panel reactive antibodies. Patients with CV ≥ 30% showed worse 1-year creatinine (1.71 ± 0.69 mg/dl vs. 1.49 ± 0.46 mg/dl, p = 0.008) than those with lower variability.

Kidney transplant recipients with high variability in tacrolimus blood levels from 3 to 12 months after transplantation have worse long-term outcome and 1-year renal function. First-year tacrolimus level variability is an independent risk factor for DCGL. CV can be easily calculated to measure immunosuppressive drug level variability and should be added to the current monitoring of kidney transplant recipients to estimate their risk and improve their outcome.

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To cite this abstract in AMA style:

Rodrigo E, Segundo DSan, Ruiz J, López-Hoyos M, Benito A, Cos Mde, Albines Z, Serrano M, Arias M. High Intra-Patient Variability in Tacrolimus Trough Blood Levels Increases the Risk of Death-Censored Graft Loss After Kidney Transplantation [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/high-intra-patient-variability-in-tacrolimus-trough-blood-levels-increases-the-risk-of-death-censored-graft-loss-after-kidney-transplantation/. Accessed June 6, 2025.

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