Renal function at two years in liver transplant patients receiving everolimus: results of a randomized, multicenter study.

Published

Journal Article

In a 24-month prospective, randomized, multicenter, open-label study, de novo liver transplant patients were randomized at 30 days to everolimus (EVR) + Reduced tacrolimus (TAC; n = 245), TAC Control (n = 243) or TAC Elimination (n = 231). Randomization to TAC Elimination was stopped prematurely due to a significantly higher rate of treated biopsy-proven acute rejection (tBPAR). The incidence of the primary efficacy endpoint, composite efficacy failure rate of tBPAR, graft loss or death postrandomization was similar with EVR + Reduced TAC (10.3%) or TAC Control (12.5%) at month 24 (difference -2.2%, 97.5% confidence interval [CI] -8.8%, 4.4%). BPAR was less frequent in the EVR + Reduced TAC group (6.1% vs. 13.3% in TAC Control, p = 0.010). Adjusted change in estimated glomerular filtration rate (eGFR) from randomization to month 24 was superior with EVR + Reduced TAC versus TAC Control: difference 6.7 mL/min/1.73 m(2) (97.5% CI 1.9, 11.4 mL/min/1.73 m(2), p = 0.002). Among patients who remained on treatment, mean (SD) eGFR at month 24 was 77.6 (26.5) mL/min/1.73 m(2) in the EVR + Reduced TAC group and 66.1 (19.3) mL/min/1.73 m(2) in the TAC Control group (p < 0.001). Study medication was discontinued due to adverse events in 28.6% of EVR + Reduced TAC and 18.2% of TAC Control patients. Early introduction of everolimus with reduced-exposure tacrolimus at 1 month after liver transplantation provided a significant and clinically relevant benefit for renal function at 2 years posttransplant.

Full Text

Duke Authors

Cited Authors

  • Saliba, F; De Simone, P; Nevens, F; De Carlis, L; Metselaar, HJ; Beckebaum, S; Jonas, S; Sudan, D; Fischer, L; Duvoux, C; Chavin, KD; Koneru, B; Huang, MA; Chapman, WC; Foltys, D; Dong, G; Lopez, PM; Fung, J; Junge, G; H2304 Study Group,

Published Date

  • July 2013

Published In

Volume / Issue

  • 13 / 7

Start / End Page

  • 1734 - 1745

PubMed ID

  • 23714399

Pubmed Central ID

  • 23714399

Electronic International Standard Serial Number (EISSN)

  • 1600-6143

Digital Object Identifier (DOI)

  • 10.1111/ajt.12280

Language

  • eng

Conference Location

  • United States