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Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial.
Nephrol Dial Transplant. 2010 Dec; 25(12):4009-17.ND

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.

Authors+Show Affiliations

Eurodial, Dialysis Unit, Leiria, Portugal. fcarrera@mail.telepac.ptNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20522670

Citation

Carrera, Fernando, et al. "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 : Official Publication of the European Dialysis and Transplant Association - European Renal Association, vol. 25, no. 12, 2010, pp. 4009-17.
Carrera F, Lok CE, de Francisco A, et al. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Nephrol Dial Transplant. 2010;25(12):4009-17.
Carrera, F., Lok, C. E., de Francisco, A., Locatelli, F., Mann, J. F., Canaud, B., Kerr, P. G., Macdougall, I. C., Besarab, A., Villa, G., Kazes, I., Van Vlem, B., Jolly, S., Beyer, U., & Dougherty, F. C. (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 : Official Publication of the European Dialysis and Transplant Association - European Renal Association, 25(12), 4009-17. https://doi.org/10.1093/ndt/gfq305
Carrera F, et al. Maintenance Treatment of Renal Anaemia in Haemodialysis Patients With Methoxy Polyethylene Glycol-epoetin Beta Versus Darbepoetin Alfa Administered Monthly: a Randomized Comparative Trial. Nephrol Dial Transplant. 2010;25(12):4009-17. PubMed PMID: 20522670.
* Article titles in AMA citation format should be in sentence-case
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 -