Date: Tuesday, May 5, 2015
Session Time: 5:30pm-6:30pm
Presentation Time: 5:30pm-6:30pm
Location: Exhibit Hall E
Aim: To compare switching off 3 different immunosuppressive (IS) regimen 4years after renal transplantation (Tx).
Methods: 802 patients (pts) were included in this prospective, open-label, randomized, controlled multi-center study with observational follow-up (FU) until Mo60 post Tx. After induction therapy with basiliximab all pts received cyclosporine A (CsA), enteric-coated mycophenolate sodium (EC-MPS) and steroids. 3Mo post Tx 499pts were randomized 1:1:1 to either i) continue standard CsA(100-180ng/ml)+EC-MPS(n=166) (STD) or convert ii) to a calcineurin inhibitor (CNI)-free regimen with everolimus (EVR)(5-10ng/ml)+EC-MPS(n=171) or iii) to a CNI-low regimen with EVR(3-8ng/ml) + reduced CsA(50-75ng/ml) (n=162). All pts continued on steroids.
Results: At 48 Mo post Tx 60 (36%) CNI-free, 43 (27%) CNI-low and 83 (51%) STD treated pts were still on their initial assigned treatment and available for Mo48 analysis. Among those pts who completed Mo48 FU visit non-switcher frequencies were 53% for CNI-free, 41% for CNI-low and 81% for STD treated pts. Drop-out frequency among FU ITT pop. from randomization to Mo48 was 17% for STD, 15% for CNI-free and 14% for CNI-low treated pts. Premature discontinuation due to AEs occurred in 5 (3%) of STD, 5 (3%) of CNI-free and 1 (1%) of CNI-low pts (safety-pop) from Mo12 to 48. Renal function (cGFR, Nankivell, LOCF) among those pts, who never switched off their assigned treatment GFR was significantly improved by +13.7ml/min/1.73m2 in favor of the CNI-free regimen at Mo48 (ITT;p<0.001).
Conclusions: Mo48 results from HERAKLES show that IS regimen using EVR with low-dose or without CNI-exposure reflect the opportunity for an individualized IS to minimize CNI-exposure. Drop-out rates over 4 years post Tx showed similar adherence rates between groups. Pts that never switched off the assigned CNI-free regimen reached a markedly improved GRF.
To cite this abstract in AMA style:Arns W, Budde K, Sommerer C, Witzke O, Guba M, Jacobi J, Vogt B, Reinke P, Hauser I, Stahl R, Rath T, Baeumer D, Porstner M, Zeier M, Lehner F, Kliem V. Month 48 Follow-Up Results of HERAKLES Trial on Three Different Treatment Regimen and Switching Off Behaviour in De Novo Renal Transplant Patients [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/month-48-follow-up-results-of-herakles-trial-on-three-different-treatment-regimen-and-switching-off-behaviour-in-de-novo-renal-transplant-patients/. Accessed May 5, 2021.
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