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Kidney Week

Abstract: SA-PO510

Everolimus [EVR]-Based versus Tacrolimus [TAC]-MPA Regimen in De Novo Kidney Transplant Recipients: 12 Months Safety and Efficacy Data from the Athena Study

Session Information

Category: Transplantation

  • 1702 Transplantation: Clinical and Translational

Authors

  • Dragun, Duska, University Hospital Charite, Campus Virchow, Berlin, Germany
  • Sommerer, Claudia, University Hospital of Heidelberg, HEIDELBERG, Germany
  • Hauser, Ingeborg Anni, University Clinic Frankfurt (UKF), Frankfurt Main, Germany
  • Suwelack, Barbara M., None, Muenster, Germany
  • Schenker, Peter, Ruhr-University Bochum, Bochum, Germany
  • Witzke, Oliver, University Duisburg-Essen, Essen, Germany
  • Hugo, Christian, University of Dresden, Dresden, Germany, Dresden, SN, Germany
  • Kamar, Nassim, Toulouse University Hospital, Toulouse, France
  • Merville, Pierre, PELLEGRIN HOSPITAL, Bordeaux, France
  • Junge, Martina, Novartis Pharma GmbH Germany, Nuremberg, Germany
  • Nashan, Björn, Bundesärztekammer , Hamburg, Germany
  • Thaiss, Friedrich, University Hospital, Hamburg, Germany

Group or Team Name

  • Athena Study Group
Background

The ATHENA study was set up to compare EVR combined with TAC or cyclosporine A [CyA] vs. mycophenolic acid [MPA] combined with TAC in de novo kidney transplant [KTx] recipients.

Methods

In this 12 months [M] prospective, open-label, multi-center study 612 patients [pts] were randomized 1:1:1 at time of Tx to either EVR (3-8ng/ml M1-M12) + TAC(4-8ng/ml M1-M3; 3-5ng/ml M3-M12), or EVR (3-8ng/ml M1-M12) + CyA (75-125ng/ml M1-M3; 50-100ng/ml M3-M12) or TAC(4-8ng/ml M1-M3; 3-5ng/ml M3-M12) + MPA, all with steroids. Here we report M12 efficacy and safety (208 EVR+TAC, 199 EVR+CyA, 205 TAC+MPA pts).

Results

M12 Kaplan Meier estimates for treated BPAR were 6.7% in EVR+TAC, 17.6% in EVR+CyA and 3.9% in TAC+MPA group, with most events graded BANFF IA (1.9%; 9%; 1.5%), few (1.5%, 2% vs 0.5%) BANFF IIB/III. 5 pts in EVR+TAC, 5 in EVR+CyA and 6 in TAC+MPA died. Few graft losses occured: 10 pts (4.8%) in EVR+TAC, 13 (6.5%) in EVR+CyA, 6 (2.9%) in TAC+MPA arm, including 5 primary non-functioning grafts in each EVR-group and 1 in TAC+MPA arm. Safety profiles were comparable, incidences of AEs/infections leading to study drug discontinuation or dose adjustment/interruption were 56.7% in EVR+TAC, 55.5% in EVR+CyA vs 61.3% in TAC+MPA arm. Main reasons for changes were infections (7.1%EVR+TAC, 4.5%EVR+CyA, 23.5%TAC control) and lympho-/leucopenia (3.3%, 3.5%, 13.2%). No differences in AEs on wound complications were seen (sum-incidences: 41.9% EVR+TAC, 38.9% EVR+CyA, 43.2% TAC+MPA).

Conclusion

ATHENA as largest European KTx study confirmed good efficacy and event rates within international standards for all 3 groups with no unexpected safety events for this pts population. There were no differences in reported AEs wound healing and less leucopenia with EVR-based regimens.

Funding

  • Commercial Support