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- Title
Efficacy and safety of conversion from cyclosporine to everolimus in living-donor kidney transplant recipients: an analysis from the ZEUS study.
- Authors
Lehner, Frank; Budde, Klemens; Zeier, Martin; Wüthrich, Rudolf P.; Reinke, Petra; Eisenberger, Ute; Mühlfeld, Anja; Arns, Wolfgang; Stahl, Rolf; Heller, Katharina; Witzke, Oliver; Wolters, Heiner H.; Suwelack, Barbara; Klehr, Hans Ulrich; Stangl, Manfred; Hauser, Ingeborg A.; Nadalin, Silvio; Porstner, Martina; May, Christoph; Paulus, Eva-Maria
- Abstract
Conversion of living-donor kidney transplant patients from calcineurin inhibitor therapy to an mTOR inhibitor is poorly documented. In the prospective, multicentre ZEUS study, 300 kidney transplant recipients without prior rejection (Banff grade >1) and serum creatinine ≤265 μmol/l were randomized to continue cyclosporine or convert to everolimus at 4.5 months post-transplant. In a post hoc analysis of 80 living-donor recipients, adjusted estimated GFR (Nankivell) at month 12 (the primary endpoint) was 74.3 (95% CI [70.7, 77.9]) ml/min/1.73 m2 with everolimus versus 63.8 (95% CI [60.0, 67.7]) ml/min/1.73 m2) with cyclosporine, a difference of 10.5 ml/min/1.73 m2 in favour of everolimus ( P < 0.001). From randomization to month 12, adjusted estimated GFR increased by a mean of 9.8 (95% CI [6.2, 13.4]) ml/min/1.73 m2 with everolimus versus −0.7 (95% CI [−4.6, 3.1]) ml/min/1.73 m2) ( P < 0.001) with cyclosporine. There were six biopsy-proven acute rejection episodes in everolimus-treated patients (five Banff grade I) and one episode in cyclosporine-treated patients (Banff grade 1). Overall safety profile was similar between groups. Discontinuation due to adverse events occurred in three everolimus patients (7.1%) and five cyclosporine patients (13.2%) between randomization and month 12. Initiation of everolimus with early elimination of calcineurin therapy is associated with a significant renal benefit at 12 months post-transplant that is observed in both living and deceased-donor recipients. (clinicaltrials.gov NCT00154310)
- Subjects
CYCLOSPORINE; EVEROLIMUS; KIDNEY exchange; KIDNEY transplant patients; CALCINEURIN; GLOMERULAR filtration rate
- Publication
Transplant International, 2014, Vol 27, Issue 11, p1192
- ISSN
0934-0874
- Publication type
Article
- DOI
10.1111/tri.12411