Effetti della dose degli agenti stimolanti l'eritropoiesi su esiti cardio-cerebrovascolari, qualità di vita e costi in emodialisi

Translated title of the contribution: Effects of dose of erythropoiesis stimulating agents on cardiovascular outcomes, quality of life and costs of haemodialysis. the clinical evaluation of the DOSe of erythropoietins (C.E. DOSE) Trial

Valeria Saglimbene, Daniela D'Alonzo, Marinella Ruospo, Mariacristina Vecchio, Patrizia Natale, Letizia Gargano, Antonio Nicolucci, Fabio Pellegrini, Jonathan Craig, Giorgio Triolo, Deni Procaccini, Antonio Santoro, Salvatore Di Giulio, S La Rosa, Angelo Murgo, R Di Toro Mammarella, M Sambati, Nicola D'Ambrosio, V Greco, G GiannoccaroA Flammini, E Boccia, G Montalto, S Pagano, S Amaru, M Fici, G Barone Lumaga, E Mancini, M Veronesi, L Patregnani, M Querques, P Schiavone, S Chimienti, R Palumbo, D Di Franco, M Della Volpe, E Gori, Mario Salomone, A Iacono, M Moscoloni, A Treglia, D Casu, A Piras, A Di Silva, M Mandreoli, A Lopez, F Quarello, L Catizone, G Russo, S Forcellini, M Maccarone, G Catucci, B Di Paulo, A Stingone, B D'Angelo, C Guastoni, S Pasquali, C Minoretti, A Bellasi, G Boscutti, M Martone, S David, F Schito, L Urban, A Di Iorio, F Caruso, A Mazzoni, R Musacchio, D Andreoli, M Cossu, G Li Cavoli, M Cornacchiari, A Granata, A Clementi, R Giordano, W Barzaghi, Miriam Valentini, Jorgen Hegbrant, Gianni Tognoni, Giovanni Strippoli

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

METHODS: We present the protocol of the Clinical Evaluation of the Dose of Erythropoietins (C.E. DOSE) trial, which will assess the benefits and harms of a high versus a low ESA dose therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD). This is a randomized, prospective open label blinded end-point (PROBE) design trial due to enroll 900 haemodialysis patients. Patients will be randomized 1:1 to 4000 UI/week i. v. versus 18000 UI/week i. v. of epoetin alfa, beta or any other epoetin in equivalent doses. The primary outcome of the trial is a composite of cardiovascular events. In addition, quality of life and costs of these two strategies will be assessed. The study has been approved and funded by the Italian Agency of Drugs (Agenzia Italiana del Farmaco (AIFA)) within the 2006 funding plan for independent research on drugs (registered at www.clinicaltrials.gov (NCT00827021)).

BACKGROUND: Anaemia 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 the most used treatment option. In observational studies, higher haemoglobin (Hb) levels (around 11-13 g/dL) are associated with improved survival and quality of life compared to Hb levels around 9-10 g/dL. Randomized studies found that targeting higher Hb levels with ESA causes an increased risk of death, mainly due to adverse cardiovascular outcomes. It is possible that this is mediated by ESA dose rather than haemoglobin concentration, although this hypothesis has never been formally tested.

Translated title of the contributionEffects of dose of erythropoiesis stimulating agents on cardiovascular outcomes, quality of life and costs of haemodialysis. the clinical evaluation of the DOSe of erythropoietins (C.E. DOSE) Trial
Original languageItalian
Number of pages15
JournalGiornale Italiano di Nefrologia
Volume30
Issue number2
Publication statusPublished - 1 Mar 2013

Fingerprint Dive into the research topics of 'Effects of dose of erythropoiesis stimulating agents on cardiovascular outcomes, quality of life and costs of haemodialysis. the clinical evaluation of the DOSe of erythropoietins (C.E. DOSE) Trial'. Together they form a unique fingerprint.

  • Cite this

    Saglimbene, V., D'Alonzo, D., Ruospo, M., Vecchio, M., Natale, P., Gargano, L., Nicolucci, A., Pellegrini, F., Craig, J., Triolo, G., Procaccini, D., Santoro, A., Di Giulio, S., La Rosa, S., Murgo, A., Di Toro Mammarella, R., Sambati, M., D'Ambrosio, N., Greco, V., ... Strippoli, G. (2013). Effetti della dose degli agenti stimolanti l'eritropoiesi su esiti cardio-cerebrovascolari, qualità di vita e costi in emodialisi. Giornale Italiano di Nefrologia, 30(2). https://giornaleitalianodinefrologia.it/giornale/marzo-aprile-2013/