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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Adv+Ther
2016 ; 33
(4
): 610-25
Nephropedia Template TP
gab.com Text
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English Wikipedia
Once-Monthly Continuous Erythropoietin Receptor Activator (C E R A ) in Patients
with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III
Trials
#MMPMID26965694
Locatelli F
; Choukroun G
; Truman M
; Wiggenhauser A
; Fliser D
Adv Ther
2016[Apr]; 33
(4
): 610-25
PMID26965694
show ga
INTRODUCTION: Erythropoiesis-stimulating agents and iron are commonly used in
patients with chronic kidney disease with the aim of correcting anemia and
maintaining stable hemoglobin levels. We analyzed pooled data from 13 studies
with similar designs included in the Umbrella Continuous Erythropoietin Receptor
Activator (C.E.R.A.) program to investigate the effects of continuous
erythropoiesis receptor activator in clinically relevant subgroups of patients
with chronic kidney disease and to determine whether the efficacy and safety
outcomes demonstrated in the overall chronic kidney disease population are
maintained in specific subgroups. METHODS: Data from 13 Phase III trials set up
with similar design were retrospectively pooled for this analysis. Patients with
chronic kidney disease who had previously been receiving epoetin or darbepoetin
were switched to continuous erythropoiesis receptor activator once-monthly after
a 4- to 8-week screening period. Patients entered a 16-week continuous
erythropoiesis receptor activator dose-titration period followed by an 8-week
evaluation period. In total, 2060 patients were included in the analysis.
Subgroups were defined based on: hemoglobin target range [lower
(10.0-12.0 g/dL)/upper (10.5-13.0 g/dL)], gender (female/male), age (<65/?65),
baseline N-terminal pro-B-type natriuretic peptide levels (<5000/?5000),
cardiovascular risk factors (diabetes/cardiac/vascular/none). RESULTS: Across all
subgroups analyzed, switching from shorter-acting erythropoiesis-stimulating
agents to continuous erythropoiesis receptor activator once-monthly maintained
stable hemoglobin concentrations in a high proportion of patients (78%), with
only moderate hemoglobin fluctuations and a low number of dose changes. The
safety profile across subgroups was as expected based on pre-existing risk
factors; observed increases in adverse events were attributable to underlying
risk factors rather than study drug. CONCLUSIONS: This retrospective analysis of
13 trials showed that continuous erythropoiesis receptor activator once-monthly
maintained stable hemoglobin levels across a number of clinically relevant
patient subgroups, including those with higher inherent cardiovascular risk. The
safety profile was consistent with that previously established in the chronic
kidney disease population. CLINICALTRIALS. GOV IDENTIFIERS:
NCT00413894/NCT00545571/NCT00517413/NCT00560404/NCT00882713/NCT00550680/NCT00576303/NCT00660023/NCT00717821/NCT00642850/NCT00605293/NCT00661505/NCT00699348.
FUNDING: F. Hoffmann-La Roche Ltd, Basel, Switzerland.