JAMDA
Volume 8, Issue 2 , Pages 83-90, February 2007

Once-Monthly Darbepoetin alfa for Maintaining Hemoglobin Levels in Older Patients With Chronic Kidney Disease

  • Anil Agarwal, MD

      Affiliations

    • The Ohio State University Medical Center, Columbus, OH
    • A.A. and M.R.S. have received consultation fees and speaker honoraria from Amgen.
    • Corresponding Author InformationAddress correspondence to Anil Agarwal, MD, The Ohio State University Medical Center, N. 210 Means Hall, 1654 Upham Drive, Columbus, OH 43210.
    • ,
  • Marcia R. Silver, MD, FACP

      Affiliations

    • Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland, OH
    • A.A. and M.R.S. have received consultation fees and speaker honoraria from Amgen.
    • ,
  • Michael Walczyk, MD

      Affiliations

    • Northwest Renal Clinic, Portland, OR
    • ,
  • Wei Liu

      Affiliations

    • Amgen Inc, Thousand Oaks, CA.
    • ,
  • Paul Audhya, MD

      Affiliations

    • Amgen Inc, Thousand Oaks, CA.

published online 04 October 2006.

Objectives

To evaluate the efficacy of once-monthly darbepoetin alfa in maintaining hemoglobin (Hb) levels between 10 and 12 g/dL in older subjects receiving darbepoetin alfa every 2 weeks.

Design

A secondary analysis of a 29-week multicenter, open-label, single-arm study with an initial 2-week screening/baseline period, followed by a 20-week once-monthly darbepoetin alfa dose titration period and an 8-week evaluation period.

Setting

Twenty treatment centers in the United States.

Participants

Subjects with CKD who were not receiving dialysis and whose hemoglobin levels were ≥10 g/dL with darbepoetin alfa every 2 weeks.

Intervention

Darbepoetin alfa administered once monthly and titrated to maintain Hb level between 10 and 12 g/dL, inclusive.

Measurements

The proportion of subjects maintaining a mean Hb concentration of 10 to 12 g/dL, inclusive, while receiving once-monthly darbepoetin alfa during the evaluation period (weeks 21 to 29); the mean change in Hb levels and darbepoetin alfa doses between baseline and the evaluation period; and the treatment relationship, frequency, severity, and outcomes of all adverse events. Analyses were stratified by age (<65, ≥65, and ≥75 years).

Results

Seventy-nine percent of subjects aged ≥65 years and 80% of subjects aged ≥75 years maintained their Hb levels within the specified target range, compared with 80% of subjects aged <65 years who maintained their Hb levels within the specified target range. Hemoglobin levels and darbepoetin alfa doses did not change significantly from baseline to the evaluation period. Darbepoetin alfa administered once monthly was well tolerated in all age groups.

Conclusion

Darbepoetin alfa administered once monthly effectively maintained target Hb levels in older subjects with CKD (not receiving dialysis) who were maintained previously with an every 2 weeks darbepoetin alfa regimen.

Keywords: Chronic kidney disease, anemia, darbepoetin alfa, extended dosing

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PII: S1525-8610(06)00374-4

doi:10.1016/j.jamda.2006.07.007

JAMDA
Volume 8, Issue 2 , Pages 83-90, February 2007

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