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

F. Lehner,¹ K. Budde,¹ R. Wuethrich,² P. Reinke,¹ W. Arns,¹ A. Muehlfeld,¹ U. Eisenberger,¹ R. Stahl,¹ K. Heller,¹ O. Witzke,¹ B. Suwelack,¹ H. Wolters,¹ I. Hauser,¹ M. Porstner,³ C. Sommerer.¹

¹ZEUS Study Group, Germany
²ZEUS Study Group, Switzerland
³Novartis, Pharma, Germany.

Meeting: 2015 American Transplant Congress

Abstract number: D149

Keywords: Immunosuppression, Kidney transplantation, Multicenter studies, Renal function

Session Information

Session Name: Poster Session D: Kidney Immunosuppression: Drug Minimization

Session Type: Poster Session

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 November 21, 2024.

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