ATHENA - Patient and Allograft Outcome Differences after Kidney Transplantation - Germany vs. France

ATHENA – Patient and Allograft Outcome Differences after Kidney Transplantation – Germany vs. France

F. Thaiss¹, C. Sommerer¹, B. Suwelack¹, D. Dragun¹, I. A. Hauser¹, O. Witzke¹, C. Hugo¹, P. Schenker¹, N. Kamar², P. Merville², I. Kroeger³, M. Junge³, B. Nashan¹

¹Athena, Study Group, Germany, ²Athena, Study Group, France, ³Novartis Pharma GmbH, Nürnberg, Germany

Meeting: 2020 American Transplant Congress

Abstract number: 333

Keywords: Immunosuppression, Infection, Kidney transplantation, Rejection

Session Information

Session Name: Immunosuppressive Drug Minimization

Session Type: Oral Abstract Session

Date: Saturday, May 30, 2020

Session Time: 3:15pm-4:45pm

Presentation Time: 4:27pm-4:39pm

Location: Virtual

*Purpose: In the ATHENA trial [NCT01843348], efficacy and safety of everolimus in combination with tacrolimus [EVR+TAC] or cyclosporine A [EVR+CyA] vs. TAC and mycophenolic acid [TAC+MPA] were evaluated in de novo kidney transplant [KTx] recipients.

*Methods: During this 12-months [M] open-label, prospective, randomized, controlled trial, 612 patients [pts] were enrolled from 12 French [FRA] and 15 German [GER] sites. Patients were randomized at a 1:1:1 ratio to either [EVR+CyA] (C₀: 3-8 ng/mL M1-12 and C₀: 75-125 ng/mL M1-3; 50-100 ng/mL M3-12, respectively), [EVR+TAC] (C₀: 3-8 ng/mL M1-12 and C₀: 4-8 ng/mL M1-3; 3-5 ng/mL M3-12, respectively), or to the control arm [TAC+MPA] (C₀: 4-8 ng/mL M1-3; 3-5 ng/mL M3-12 and 1440-2000 mg/d M1-12); all with steroids. Here, we report efficacy and safety data at M12 analyzed by country (Germany vs. France) for N=199, N=208, and N=205 pts receiving EVR+CyA, EVR+TAC, and TAC+MPA, respectively.

*Results: Country-dependent outcome differed from the overall intent-to-treat (ITT) study results in the two country cohorts GER/FRA. Occurrence of treated BPAR excluding BANFF IA was 16.7/7.3%, 10.3/6.5%, and 5.3/13.2% in EVR+CyA, EVR+TAC, and MPA+TAC arms in the GER/FRA cohorts, respectively. Regarding CMV infections, one of the key secondary endpoints, significantly less occurrences were detected overall in the EVR-based regimens (in 2.5% of EVR+CyA, 6.2% of EVR+TAC, vs. 20.6% of MPA+TAC treated pts; ITT; p<0.01). However, also here the analysis revealed country-dependent differences with CMV infections in 2.8/1.8%, 8.1/1.6%, and 22.5/15.1% in the GER/FRA cohorts for treatment with EVR+CyA, EVR+TAC, and MPA+TAC, respectively.

*Conclusions: The as to date largest randomized European KTx study ATHENA confirmed overall good efficacy across all three treatment arms. Interestingly, country-wise analyses revealed differences regarding treatment attitudes and outcomes in KTx populations of the two neighboring European countries France and Germany, which will be presented with potential reasons for these observations discussed in detail.

To cite this abstract in AMA style:

Thaiss F, Sommerer C, Suwelack B, Dragun D, Hauser IA, Witzke O, Hugo C, Schenker P, Kamar N, Merville P, Kroeger I, Junge M, Nashan B. ATHENA – Patient and Allograft Outcome Differences after Kidney Transplantation – Germany vs. France [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/athena-patient-and-allograft-outcome-differences-after-kidney-transplantation-germany-vs-france/. Accessed November 22, 2024.

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