Tacrolimus exposure in the real world: An analysis from the Mycophenolic acid Observational REnal transplant study

Fuad S. Shihab, Ali Olyaei, Anne Wiland, Kevin Mccague, Douglas J. Norman

Research output: Contribution to journalArticle

6 Scopus citations

Abstract

Tacrolimus exposure and renal function data to 36 months post-transplant were analyzed from the prospective, observational Mycophenolic acid Observational REnal transplant (MORE) registry in which de novo kidney transplant patients were managed according to local practice. Tacrolimus trough (C0) concentration at month 12 was stratified as low (<6 ng/mL), moderate (6-8 ng/mL), or high (>8 ng/mL) in 724 patients. Estimated glomerular filtration rate (eGFR) was stratified as low (<60 mL/min/1.73 m2) or high (≥60 mL/min/1.73 m2). High tacrolimus C0 (>8 ng/mL) was observed in 47.7%, 34.1%, 26.8%, and 26.7% of patients at baseline and months 12, 24, and 36, respectively. Biopsy-proven acute rejection was similar to month 36 regardless of tacrolimus C0 category at month 12. Tacrolimus C0 >8 ng/mL vs. <6 ng/mL at month 12 was predictive of low eGFR at month 24 (p = 0.023) with a nonsignificant trend at month 36 (p = 0.085). Infections (p < 0.013) and BK virus infection (p < 0.001) were most frequent in the low tacrolimus C0 cohort. Neutropenia was most frequent in the high tacrolimus C0 category (p = 0.010). In conclusion, over a quarter of patients were exposed to high tacrolimus C0 to 36 months post-transplant. Tacrolimus exposure did not affect rejection risk, but tacrolimus C0 >8 ng/mL at month 12 was predictive of subsequent low eGFR compared to C0 <6 ng/mL.

Original languageEnglish (US)
Pages (from-to)768-775
Number of pages8
JournalClinical Transplantation
Volume28
Issue number7
DOIs
StatePublished - Jul 2014

Keywords

  • Clinical
  • Dose
  • Evolution
  • Exposure
  • Kidney transplantation
  • Mycophenolic acid Observational REnal transplant
  • Reduction
  • Tacrolimus

ASJC Scopus subject areas

  • Transplantation

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