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- Title
Histological findings to five years after early conversion of kidney transplant patients from cyclosporine to everolimus: an analysis from the randomized ZEUS study.
- Authors
Eisenberger, Ute; Budde, Klemens; Lehner, Frank; Sommerer, Claudia; Reinke, Petra; Witzke, Oliver; Wüthrich, Rudolf P.; Stahl, Rolf; Heller, Katharina; Suwelack, Barbara; Mühlfeld, Anja; Hauser, Ingeborg A.; Nadalin, Silvio; Porstner, Martina; Arns, Wolfgang; on behalf of the ZEUS Study Investigators; ZEUS Study Investigators
- Abstract
<bold>Background: </bold>Conversion from calcineurin inhibitor (CNI) therapy to everolimus within 6 months after kidney transplantation improves long-term graft function but can increase the risk of mild biopsy-proven acute cellular rejection (BPAR). We performed a post-hoc analysis of histological data from a randomized trial in order to further analyze histologic information obtained from indication and protocol biopsies up to 5 years after transplantation.<bold>Methods: </bold>Biopsy samples obtained up to 5 years post-transplant were analyzed from the randomized ZEUS study, in which kidney transplant patients were randomized at month 4.5 to switch to everolimus (n = 154) or remain on cyclosporine (CsA)-based immunosuppression (n = 146). All patients received mycophenolate and steroids.<bold>Results: </bold>At least one investigator-initiated biopsy was undertaken in 53 patients in each group between randomization and year 5, with a mean (SD) of 2.6 (1.7) and 2.2 (1.4) biopsies per patient in the everolimus and CsA groups, respectively. In the everolimus and CsA groups, investigator-initiated biopsies showed (i) BPAR in 12.3 and 7.5% (p = 0.182) of patients, respectively, with episodes graded mild in 22/24 and 18/20 cases (ii) CsA toxicity lesions in 4.5 and 10.3% of patients (p = 0.076) (iii) antibody-mediated rejection in 0.6 and 2.7% of patients (p = 0.204), respectively.<bold>Conclusions: </bold>This analysis of histological findings in the ZEUS study to 5 years after kidney transplantation shows no increase in antibody-mediated rejection under everolimus-based therapy with a lower rate of CNI-related toxicity compared to a conventional CsA-based regimen, and confirms the preponderance of mild BPAR seen in the main study after the early switch to CsA-free everolimus therapy.<bold>Trial Registration: </bold>ClinicalTrials.gov NCT00154310 . Date of registration: September 12, 2005.
- Subjects
KIDNEY transplantation; CYCLOSPORINE; EVEROLIMUS; BIOPSY; CALCINEURIN
- Publication
BMC Nephrology, 2018, Vol 19, Issue 1, pN.PAG
- ISSN
1471-2369
- Publication type
journal article
- DOI
10.1186/s12882-018-0950-1