Effects of the dose of erythropoiesis stimulating agents on cardiovascular events, quality of life, and health-related costs in hemodialysis patients: The clinical evaluation of the dose of erythropoietins (C.E. DOSE) trial protocol

Saglimbene, Valeria, Maione, Ausilia, Vecchio, Mariacristina, Nicolucci, Antonio, Pellegrini, Fabio, Navaneethan, Sankar D., Palmer, Suetonia, Craig, Jonathan C., Triolo, Giorgio, Procaccini, Deni A., Santoro, Antonio, Di Giulio, Salvatore, Bonifati, Carmen, Di Micco, Lucia, La Rosa, Sandra, Murgo, Angelo, Di Toro Mammarella, Rinaldo, Sambati, Marialucia, D'Ambrosio, Nicola, Greco, Virginia, Dagostino, Filippo, Giannoccaro, Giuliano, Flammini, Alessandro, Tedesco, Michela, Boccia, Eligio, Di Franco, Damiano, Malaguti, Moreno, Falco, Mariano, Montalto, Giuseppina, Amarù, Salvatore, Fici, Michele, Amoroso, Luigi, D'Alonzo, Daniela, Valentini, Miriam, Palumbo, Roberto, Vischini, Gisella, Gori, Elena, Vernaglione, Luigi, Casu, Domenica, Mandreoli, Marcora, Querques, Marialuisa, Hegbrant, Jorgen, Johnson. David W., Tognoni, Gianni and Strippoli, Giovanni F. M. (2010) Effects of the dose of erythropoiesis stimulating agents on cardiovascular events, quality of life, and health-related costs in hemodialysis patients: The clinical evaluation of the dose of erythropoietins (C.E. DOSE) trial protocol. Trials, 11 70-1-70-7. doi:10.1186/1745-6215-11-70

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Author Saglimbene, Valeria
Maione, Ausilia
Vecchio, Mariacristina
Nicolucci, Antonio
Pellegrini, Fabio
Navaneethan, Sankar D.
Palmer, Suetonia
Craig, Jonathan C.
Triolo, Giorgio
Procaccini, Deni A.
Santoro, Antonio
Di Giulio, Salvatore
Bonifati, Carmen
Di Micco, Lucia
La Rosa, Sandra
Murgo, Angelo
Di Toro Mammarella, Rinaldo
Sambati, Marialucia
D'Ambrosio, Nicola
Greco, Virginia
Dagostino, Filippo
Giannoccaro, Giuliano
Flammini, Alessandro
Tedesco, Michela
Boccia, Eligio
Di Franco, Damiano
Malaguti, Moreno
Falco, Mariano
Montalto, Giuseppina
Amarù, Salvatore
Fici, Michele
Amoroso, Luigi
D'Alonzo, Daniela
Valentini, Miriam
Palumbo, Roberto
Vischini, Gisella
Gori, Elena
Vernaglione, Luigi
Casu, Domenica
Mandreoli, Marcora
Querques, Marialuisa
Hegbrant, Jorgen
Johnson. David W.
Tognoni, Gianni
Strippoli, Giovanni F. M.
Title Effects of the dose of erythropoiesis stimulating agents on cardiovascular events, quality of life, and health-related costs in hemodialysis patients: The clinical evaluation of the dose of erythropoietins (C.E. DOSE) trial protocol
Journal name Trials   Check publisher's open access policy
ISSN 1745-6215
Publication date 2010-06-09
Sub-type Article (original research)
DOI 10.1186/1745-6215-11-70
Open Access Status DOI
Volume 11
Start page 70-1
End page 70-7
Total pages 7
Place of publication London, U.K.
Publisher BioMed Central
Collection year 2011
Language eng
Formatted abstract
Background:
Anemia is a risk factor for death, adverse cardiovascular outcomes and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESA) are commonly used to increase hemoglobin levels in this population. In observational studies, higher hemoglobin levels (around 11-13 g/dL) are associated with improved survival and quality of life compared to hemoglobin levels around 9-10 g/dL. A systematic review of randomized trials found that targeting higher hemoglobin levels with ESA causes an increased risk of adverse vascular outcomes. It is possible, but has never been formally tested in a randomized trial, that ESA dose rather than targeted hemoglobin concentration itself mediates the increased risk of adverse vascular outcomes. The Clinical Evaluation of the DOSe of Erythropoietins (C.E. DOSE) trial will assess the benefits and harms of a high versus a low fixed ESA dose for the management of anemia in patients with end stage
kidney disease.

Methods/Design:
This is a randomized, prospective open label blinded end-point (PROBE) trial due to enrol 2204 hemodialysis patients in Italy. Patients will be randomized 1:1 to 4000 IU/week versus 18000 IU/week of intravenous epoietin alfa or beta, or any other ESA in equivalent doses. The dose will be adjusted only if hemoglobin levels fall outside the 9.5-12.5 g/dL range. The primary outcome will be a composite of all-cause mortality, non fatal stroke, non fatal myocardial infarction and hospitalization for cardiovascular causes. Quality of life and costs will also be assessed.

Discussion:
The C.E.DOSE study will help inform the optimal therapeutic strategy for the management of anemia of hemodialysis patients, improving clinical outcomes, quality of life and costs, by ascertaining the potential benefits and harms of different fixed ESA doses.
© 2010 Clinical Evaluation of the DOse of Erythropoietins Study Group (C.E. DOSE) and Strippoli; licensee BioMed Central Ltd.
Keyword Chornic kidney-disease
Hematocrit values
Epotin-alpha
Mortality
Anemia
SF-36
Q-Index Code CX
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Article number 70.

Document type: Journal Article
Sub-type: Article (original research)
Collections: Non HERDC
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Citation counts: TR Web of Science Citation Count  Cited 11 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 14 times in Scopus Article | Citations
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Created: Wed, 23 Mar 2011, 08:33:38 EST by Debbie Banks on behalf of School of Medicine