TY - JOUR T1 - Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. AU - Carrera,Fernando, AU - Lok,Charmaine E, AU - de Francisco,Angel, AU - Locatelli,Francesco, AU - Mann,Johannes F E, AU - Canaud,Bernard, AU - Kerr,Peter G, AU - Macdougall,Iain C, AU - Besarab,Anatole, AU - Villa,Giuseppe, AU - Kazes,Isabelle, AU - Van Vlem,Bruno, AU - Jolly,Shivinder, AU - Beyer,Ulrich, AU - Dougherty,Frank C, AU - ,, Y1 - 2010/06/03/ PY - 2010/6/5/entrez PY - 2010/6/5/pubmed PY - 2011/4/19/medline SP - 4009 EP - 17 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol Dial Transplant VL - 25 IS - 12 N2 - 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. SN - 1460-2385 UR - https://www.unboundmedicine.com/medline/citation/20522670/Maintenance_treatment_of_renal_anaemia_in_haemodialysis_patients_with_methoxy_polyethylene_glycol_epoetin_beta_versus_darbepoetin_alfa_administered_monthly:_a_randomized_comparative_trial_ L2 - https://academic.oup.com/ndt/article-lookup/doi/10.1093/ndt/gfq305 DB - PRIME DP - Unbound Medicine ER -