Darbepoetin alfa effectively treats anemia in patients with chronic kidney disease with de novo every-other-week administration

Robert D. Toto, Vincent Pichette, Jesus Navarro, Robert Brenner, Wendi Carroll, Wei Liu, Simon Roger

Research output: Contribution to journalArticle

60 Citations (Scopus)

Abstract

Aim: This multicenter, open-label study determined safety and efficacy of once-every-other-week administration of darbepoetin alfa for anemia of chronic kidney disease in erythropoietin-naive patients not on dialysis. Methods: Participants with hemoglobin levels <11.0 g/dl at baseline were administered darbepoetin alfa at an initial dosage of 0.75 μg/kg once every other week. The dose was titrated to achieve and maintain a hemoglobin response, defined as a hemoglobin range of between 11.0 and 13.0 g/dl for up to 24 weeks. The primary end point was the dose of darbepoetin alfa at initial hemoglobin response. Results: Six hundred and eight patients were enrolled, and 463 completed the study; 95% (95% confidence interval: 0.93, 0.97) of the patients who completed treatment achieved a hemoglobin response. The mean darbepoetin alfa dose at the time of response was 63.5 ± (SD) 16.9 μg, and the mean time to hemoglobin response was 5.7 ± (SD) 4.5 weeks. Oral iron therapy was administered to 60% and intravenous iron to 16% of the participants. Darbepoetin alfa was well tolerated, and adverse events were consistent with those expected in patients with chronic kidney disease. Conclusion: Darbepoetin alfa administered once every other week is effective and safe for achieving and maintaining target hemoglobin levels in anemic patients with chronic kidney disease.

Original languageEnglish (US)
Pages (from-to)453-460
Number of pages8
JournalAmerican Journal of Nephrology
Volume24
Issue number4
DOIs
StatePublished - 2004

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Chronic Renal Insufficiency
Anemia
Hemoglobins
Iron
Erythropoietin
Darbepoetin alfa
Dialysis
Confidence Intervals
Safety
Therapeutics

Keywords

  • Cardiovascular mortality
  • Clinical nephrology
  • Erythropoietin

ASJC Scopus subject areas

  • Nephrology

Cite this

Darbepoetin alfa effectively treats anemia in patients with chronic kidney disease with de novo every-other-week administration. / Toto, Robert D.; Pichette, Vincent; Navarro, Jesus; Brenner, Robert; Carroll, Wendi; Liu, Wei; Roger, Simon.

In: American Journal of Nephrology, Vol. 24, No. 4, 2004, p. 453-460.

Research output: Contribution to journalArticle

Toto, Robert D. ; Pichette, Vincent ; Navarro, Jesus ; Brenner, Robert ; Carroll, Wendi ; Liu, Wei ; Roger, Simon. / Darbepoetin alfa effectively treats anemia in patients with chronic kidney disease with de novo every-other-week administration. In: American Journal of Nephrology. 2004 ; Vol. 24, No. 4. pp. 453-460.
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N2 - Aim: This multicenter, open-label study determined safety and efficacy of once-every-other-week administration of darbepoetin alfa for anemia of chronic kidney disease in erythropoietin-naive patients not on dialysis. Methods: Participants with hemoglobin levels <11.0 g/dl at baseline were administered darbepoetin alfa at an initial dosage of 0.75 μg/kg once every other week. The dose was titrated to achieve and maintain a hemoglobin response, defined as a hemoglobin range of between 11.0 and 13.0 g/dl for up to 24 weeks. The primary end point was the dose of darbepoetin alfa at initial hemoglobin response. Results: Six hundred and eight patients were enrolled, and 463 completed the study; 95% (95% confidence interval: 0.93, 0.97) of the patients who completed treatment achieved a hemoglobin response. The mean darbepoetin alfa dose at the time of response was 63.5 ± (SD) 16.9 μg, and the mean time to hemoglobin response was 5.7 ± (SD) 4.5 weeks. Oral iron therapy was administered to 60% and intravenous iron to 16% of the participants. Darbepoetin alfa was well tolerated, and adverse events were consistent with those expected in patients with chronic kidney disease. Conclusion: Darbepoetin alfa administered once every other week is effective and safe for achieving and maintaining target hemoglobin levels in anemic patients with chronic kidney disease.

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