Abstract: FR-OR078

Athena Study Outcomes on Allograft Function after 12 Months with Everolimus-Based versus Tacrolimus-MPA Regimen in De Novo Renal Transplant Recipients

Session Information

Category: Transplantation

  • 1702 Transplantation: Clinical and Translational

Authors

  • Thaiss, Friedrich, University Hospital, Hamburg, Germany
  • Merville, Pierre, PELLEGRIN HOSPITAL, Bordeaux, France
  • Junge, Martina, Novartis Pharma GmbH Germany, Nuremberg, Germany
  • Nashan, Björn, Bundesärztekammer , Hamburg, Germany
  • Suwelack, Barbara M., None, Muenster, Germany
  • Sommerer, Claudia, University Hospital of Heidelberg, HEIDELBERG, Germany
  • Dragun, Duska, University Hospital Charite, Campus Virchow, Berlin, Germany
  • Hauser, Ingeborg Anni, University Clinic Frankfurt (UKF), Frankfurt Main, 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

Group or Team Name

  • Athena Study Group
Background

The ATHENA study was designed to compare efficacy, safety and outcomes on renal function [GFR] of everolimus [EVR] combined with tacrolimus [TAC] or cyclosporine A [CyA] vs. a standard regimen of mycophenolic acid [MPA] +TAC in de novo kidney transplant [KTx] recipients.

Methods

In this 12 months [M], prospective, randomized study with 15 German and 12 French sites, 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 control TAC (4-8ng/ml M1-M3; 3-5ng/ml M3-M12) +MPA. Steroids were to be continued. Here we report M12 outcomes on allograft function from ITT full analysis set with 208 EVR+TAC vs 199 EVR+CyA vs 205 TAC+MPA pts.

Results

From rdz to M12 allograft recovery was good in all 3 treatment groups with increase in GFR (Nankivell) as ΔeGFR M1-M12: a) EVR+TAC +6.6ml/min, b) EVR+CyA +9.6ml/min, c) TAC+MPA +7.6 ml/min (not significantly different). Analysis of donor age categories [<35; 35-49; 50-64; >65 years] showed that donor age >65years had worst renal allograft outcomes, regardless of treatment. Urinary protein excretion at M12 was not different between groups with a category analysis showing only 3.7% of TAC+MPA vs 1.3% of TAC+EVR vs 0.7% of CyA+EVR pts had proteinuria in nephrotic range [>339mg/mmol] at M12.

Conclusion

ATHENA, the largest European KTx study, showed comparable improvement in renal allograft function between all treatment groups with no difference in measured urinary protein excretion after 12 Mo drug exposure. Strongest impact on post Tx GFR appears to be determined by donor age, which is shown here for the first time in a large prospective study.

Funding

  • Commercial Support