Allograft Function after 12 Months with Everolimus Plus Either Tacrolimus or Cyclosporine Compared to a Standard Regimen of Tacrolimus with MPA in De Novo Renal Transplant Recipients: The ATHENA Study

B. Nashan,¹ C. Sommerer,¹ B. Suwelack,¹ D. Dragun,¹ O. Witzke,¹ C. Hugo,¹ N. Kamar,² P. Merville,² A. Hauser,¹ P. Schenker,¹ M. Junge,³ F. Thaiss.¹

¹Athena Study Group, Germany
²Athena Study Group, France
³Novartis, Pharma, Germany.

Meeting: 2018 American Transplant Congress

Abstract number: 38

Keywords: Kidney transplantation, Proteinuria, Renal function

Session Information

Session Name: Concurrent Session: Kidney Immunosuppression: mTORi Based Regimens

Session Type: Concurrent Session

Date: Sunday, June 3, 2018

Session Time: 2:30pm-4:00pm

Presentation Time: 3:30pm-3:42pm

Location: Room 6A

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 prospective, open-label, 12 months [M], randomized study with 15 German and 12 French sites, 612 patients [pts] were randomized 1:1:1 at time of Tx to a regimen of 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; all with steroids. 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 randomization to M12 allograft recovery was good in all 3 treatment groups with increase in GFR (Nankivell) as [Delta]eGFR M1-M12: for EVR+TAC group +6.6ml/min vs EVR+CyA group +9.6ml/min and for TAC+MPA group +7.6 ml/min (not significantly different). Analysis of deceased donor age categories [<35; 35-49; 50-64; >65 years] showed that donor age had significant impact on the outcome of renal function, regardless of treatment group (p<0.001). Incidence of graft loss was overall low: 4.8% (10 pts) in EVR+TAC vs 6.5% (13 pts) in EVR+CyA and 2.9% (6 pts) in TAC+MPA group – including 5 primary non-functioning grafts / cold ischemia lesions in each of the EVR-groups and 1 in TAC+MPA group. There was no difference in urinary protein excretion at M12 between groups; incidence of proteinuria in nephrotic range [>339mg/mmol] was 3.7% in TAC+MPA vs 1.3% in TAC+EVR vs 0.7% in CyA+EVR treated pts at M12.

Conclusion: ATHENA, the to date 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. Deceased donor age has been shown to have a significant impact on GFR, which is presented here for the first time in a large prospective randomized study.

CITATION INFORMATION: Nashan B., Sommerer C., Suwelack B., Dragun D., Witzke O., Hugo C., Kamar N., Merville P., Hauser A., Schenker P., Junge M., Thaiss F. Allograft Function after 12 Months with Everolimus Plus Either Tacrolimus or Cyclosporine Compared to a Standard Regimen of Tacrolimus with MPA in De Novo Renal Transplant Recipients: The ATHENA Study Am J Transplant. 2017;17 (suppl 3).

To cite this abstract in AMA style:

Nashan B, Sommerer C, Suwelack B, Dragun D, Witzke O, Hugo C, Kamar N, Merville P, Hauser A, Schenker P, Junge M, Thaiss F. Allograft Function after 12 Months with Everolimus Plus Either Tacrolimus or Cyclosporine Compared to a Standard Regimen of Tacrolimus with MPA in De Novo Renal Transplant Recipients: The ATHENA Study [abstract]. https://atcmeetingabstracts.com/abstract/allograft-function-after-12-months-with-everolimus-plus-either-tacrolimus-or-cyclosporine-compared-to-a-standard-regimen-of-tacrolimus-with-mpa-in-de-novo-renal-transplant-recipients-the-athena-study/. Accessed December 3, 2024.

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