Unit dosing of darbepoetin alfa for thetreatment of anemia in patients with end-stage renal disease being switched from recombinant human erythropoietin: Results of a phase IIIb, 27-week, multicenter, open-label study in Greek patients

Darbepoetin alfa (DA) is a unique long-acting treatment for anaemia in patients with chronic renal failure (CRF). This study assessed the mean dose of DA to achieve and maintain haemoglobin (Hb) levels between 11 g/dl and 13 g/dl in CRF children aged 11 years to 18 years. This observational, prospective study was conducted in 39 patients treated with DA. Twenty-nine patients were switched from recombinant human erythropoietin (r-HuEPO), and ten patients were naive to r-HuEPO. Naive patients received initial doses of 0.45 μg/kg of DA. Switched patients received a dose adjusted to the prior dose of r-HuEPO (200 IU r-HuEPO:1 μg DA). Among the switched patients, 79.3% received dialysis. No naive patients underwent dialysis. Overall, 74% of patients showed increased Hb level, with a mean value of 11.6±1.6 g/dl, using a mean DA dose of 0.63±0.48 μg/kg per week, and 66.7% patients reached the Pediatr Nephrol (2007) target Hb level. Hb increased in naive patients from 9.5 (95% CI: 7.7, 11.4) to 11.7 (95% CI: 10.9, 12.6) g/dl and in switched patients from 11.1 (95% CI: 10.6, 11.5) to 11.5 (95% CI: 10.8, 12.2) g/dl). Higher doses of DA were needed in the "switched" than in the "naive" patients to maintain Hb levels over 11 g/dl, respectively 0.73 (95% CI: 0.54, 0.92) and 0.34 (95% CI: 0.16, 0.52) μg/kg per week. Our results indicate the doses of DA necessary to treat CRF patients aged 11 years to 18 years. DA was an effective treatment to stabilise CRF patients at extended dosing intervals.

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Darbepoetin, effective treatment of anaemia in paediatric patients with chronic renal failure

André

Deschênes

Boudailliez

et al. 2007

Pediatr Nephrol

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Traitement par la darbepoetin alfa de l'anémie liée à l'insuffisance rénale chronique chez les patients dialysés : résultats d'une étude multicentrique française

Kessler

Hannedouche

Fitte

et al. 2006

Néphrologie & Thérapeutique

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Unit dosing of darbepoetin alfa for thetreatment of anemia in patients with end-stage renal disease being switched from recombinant human erythropoietin: Results of a phase IIIb, 27-week, multicenter, open-label study in Greek patients

Abstract: Darbepoetin alfa effectively maintained Hb concentrations within the target range without an increase in dose, even at a reduced dosing frequency. Overall, darbepoetin alfa was well tolerated.

Cited by 2 publications

References 18 publications

Darbepoetin, effective treatment of anaemia in paediatric patients with chronic renal failure

Darbepoetin, effective treatment of anaemia in paediatric patients with chronic renal failure

Traitement par la darbepoetin alfa de l'anémie liée à l'insuffisance rénale chronique chez les patients dialysés : résultats d'une étude multicentrique française

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