Efficacy and safety of once-daily LCP-Tacrolimus versus twice-daily immediate-release tacrolimus in adult Hispanic stable kidney transplant recipients: Sub-group analysis from a phase 3 trial

Arman Faravardeh, Sanjeev Akkina, Rafael Villicana, Giselle Guerra, Misbah A. Moten, Ulf Meier-Kriesche, Daniel R. Stevens, Samir J. Patel, Suphamai Bunnapradist

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The pharmacokinetics and metabolism of tacrolimus, an immunosuppressant commonly used to prevent transplant rejection, can differ in specific subpopulations. This analysis examined treatment outcomes and safety of immediate-release tacrolimus (IR-Tac) and LCP-tacrolimus (LCPT) in stable Hispanic kidney transplant recipients. Material/Methods: This was a post hoc analysis of clinical trial data from Hispanic adult stable kidney transplant recipients randomized to remain on IR-Tac or convert from IR-Tac to a reduced dose of LCPT (NCT00817206). Composite treatment failure was evaluated at 12 months. Estimated glomerular filtration rate and tacrolimus trough concentrations were evaluated over 12 months. Results: Fifty-five stable (LCPT n=26, IR-Tac n=29) kidney transplant recipients who self-identified as Hispanic or Latino were included in this analysis. Composite treatment failure occurred in 1 patient (4%) who converted to LCPT and 1 (3%) who remained on IR-Tac. The estimated glomerular filtration rate was stable over time and simi­lar in the 2 treatment groups (P=0.08). Tacrolimus trough levels for both groups were similar over time in the 2 treatment groups (P=0.98). Treatment-emergent adverse events were similar in patients who converted to LCPT and in those who remained on IR-Tac. Conclusions: Efficacy and safety were similar in Hispanic kidney transplant recipients who converted from IR-Tac to LCPT and in those remaining on IR-Tac.

Original languageEnglish (US)
Article numbere929535
JournalAnnals of Transplantation
Volume26
DOIs
StatePublished - 2021

Keywords

  • Glomerular Filtration Rate
  • Graft Rejection
  • Kidney Transplantation
  • Safety
  • Tacrolimus

ASJC Scopus subject areas

  • Transplantation

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