Date: Tuesday, May 5, 2015
Session Time: 5:30pm-6:30pm
Presentation Time: 5:30pm-6:30pm
Location: Exhibit Hall E
Background: To study renal function and patient outcome after 5 years in living donation subgroup of kidney de novo transplant recipients after conversion to an everolimus (EVR) based regimen and withdrawal of calcineurin inhibitor therapy.
Methods: Post hoc subgroup analysis from the prospective, open-label, controlled, multi-center study ZEUS. 300 renal transplant (Tx) patients were randomized at month (Mo) 4.5 post Tx to either receive EVR plus enteric coated-mycophenolate sodium (EC-MPS ) or cyclosporine (CsA) plus EC-MPS regimen, among them 80 living donor (LD) recipients (EVR group n=42; CsA group n=38). Observational follow-up (FU) on pts safety and efficacy was done until Mo60 post Tx.
Results: Adjusted eGFR (Nankivell) in living donation subpopulation at Mo60 was 67.0 (95% CI [62.2;71.9]) mL/min/1.73m2 in EVR vs 60.5 (95% CI [55.2;65.7]) mL/min/1.73m2 in CsA pts, resulting in a difference of +6.6mL/min/1.73m2 in favor of EVR pts (p<0.01). Unadjusted mean eGFR at Mo60 was 69.5 ml/min for EVR vs 60.6 ml/min for CsA (p=0.03). BPARs during FU after Mo12 occurred in 4 pts of the EVR and 3 of the CsA group, all BANFF grade IA except one BANFF grade IIA among EVR pts. From randomization to Mo60 one death occurred in CsA living donor recipients, two in the EVR living donation subgroup; one graft loss occurred in the EVR, none in the CsA group. Overall safety profile was similar between both treatment groups.
Conclusions: The presented analysis shows that EVR-based regimen with early elimination of CNI therapy in living donor kidney transplant recipients is associated with a significant benefit on renal function maintained for 60Mo post Tx without compromising safety and efficacy.
To cite this abstract in AMA style:Lehner F, Budde K, Wuethrich R, Reinke P, Arns W, Muehlfeld A, Eisenberger U, Stahl R, Heller K, Witzke O, Suwelack B, Wolters H, Hauser I, Porstner M, Sommerer C. Post Hoc Subgroup Analysis of ZEUS: Outcome on Renal Function, Efficacy and Safety in Living-Donor Kidney Transplant Recipients After Conversion from a Calcineurin Inhibitor to an Everolimus Based Regimen: 5 Year Follow-Up Data [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/post-hoc-subgroup-analysis-of-zeus-outcome-on-renal-function-efficacy-and-safety-in-living-donor-kidney-transplant-recipients-after-conversion-from-a-calcineurin-inhibitor-to-an-everolimus-based-reg/. Accessed March 28, 2020.
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