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2018 ; 19
(1
): 154
Nephropedia Template TP
gab.com Text
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English Wikipedia
Histological findings to five years after early conversion of kidney transplant
patients from cyclosporine to everolimus: an analysis from the randomized ZEUS
study
#MMPMID29954336
Eisenberger U
; Budde K
; Lehner F
; Sommerer C
; Reinke P
; Witzke O
; Wüthrich RP
; Stahl R
; Heller K
; Suwelack B
; Mühlfeld A
; Hauser IA
; Nadalin S
; Porstner M
; Arns W
BMC Nephrol
2018[Jun]; 19
(1
): 154
PMID29954336
show ga
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION:
ClinicalTrials.gov NCT00154310 . Date of registration: September 12, 2005.