Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial.

Carrera, Fernando;Lok, Charmaine E;de Francisco, Angel;Locatelli, Francesco;Goffin, Eric;et.al.
(2010) Nephrology, Dialysis, Transplantation — Vol. 25, n° 12, p. 4009-4017 (2010)

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Authors
  • Carrera, Fernando
    Author
  • Lok, Charmaine E
    Author
  • de Francisco, Angel
    Author
  • Locatelli, Francesco
    Author
  • Goffin, EricUCLouvain
    Collaborator
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Abstract
BACKGROUND: Several studies with erythropoiesis-stimulating agents claim that maintenance therapy of renal anaemia may be possible at extended dosing intervals; however, few studies were randomized, results varied, and comparisons between agents were absent. We report results of a multi-national, randomized, prospective trial comparing haemoglobin maintenance with methoxy polyethylene glycol-epoetin beta and darbepoetin alfa administered once monthly. METHODS: Haemodialysis patients (n = 490) on stable once-weekly intravenous darbepoetin alfa were randomized to methoxy polyethylene glycol-epoetin beta once monthly or darbepoetin alfa every 2 weeks for 26 weeks, with dose adjustment for individual haemoglobin target (11-13 g/dL; maximum decrease from baseline 1 g/dL). Subsequently, patients entered a second 26-week period of once-monthly methoxy polyethylene glycol-epoetin beta and darbepoetin alfa. The primary endpoint was the proportion of patients who maintained average haemoglobin ≥10.5 g/dL, with a decrease from baseline ≤1 g/dL, in Weeks 50-53; the secondary endpoint was dose change over time. The trial is registered at www.ClinicalTrials.gov, number NCT00394953. RESULTS: Baseline characteristics were similar between groups. One hundred and fifty-seven of 245 patients treated with methoxy polyethylene glycol-epoetin beta and 99 of 245 patients with darbepoetin alfa met the response definition (64.1% and 40.4%; P < 0.0001). Doses increased by 6.8% with methoxy polyethylene glycol-epoetin beta and 58.8% with darbepoetin alfa during once-monthly treatment. Death rates were equal between treatments (5.7%). Most common adverse events included hypertension, procedural hypotension, nasopharyngitis and muscle spasms, with no differences between groups. CONCLUSIONS: Methoxy polyethylene glycol-epoetin beta maintained target haemoglobin more successfully than darbepoetin alfa at once-monthly dosing intervals despite dose increases with darbepoetin alfa
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Carrera, F., Lok, C. E., de Francisco, A., Locatelli, F., Mann, J. F. E., Canaud, B., Kerr, P. G., Macdougall, I. C., Besarab, A., Villa, G., Kazes, I., Van Vlem, B., Jolly, S., Beyer, U., Dougherty, F. C., & PATRONUS Investigators. (2010). Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Nephrology, Dialysis, Transplantation, 25(12), 4009-4017. https://doi.org/10.1093/ndt/gfq305 (Original work published 2010)