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Clin J Am Soc Nephrol. 2008 Jul;3(4):1015-21. doi: 10.2215/CJN.05681207. Epub 2008 Apr 9.

A randomized study of extended dosing regimens for initiation of epoetin alfa treatment for anemia of chronic kidney disease.

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1
New York Hospital Queens, 56-45 Main Street, Flushing, NY 11355, USA. bss9001@nyp.org

Abstract

BACKGROUND AND OBJECTIVES:

Although epoetin alfa is commonly initiated weekly (QW) in anemic chronic kidney disease (CKD) patients, recent evidence indicates that it can be initiated every 2 wk (Q2W) and used in maintenance therapy every 4 wk (Q4W). This study examined the feasibility of initiating epoetin alfa Q4W in anemic CKD patients not receiving dialysis.

DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:

This open-label study randomized subjects (1:2:2:2) to treatment with epoetin alfa 10,000 IU QW, 20,000 IU Q2W, 20,000 IU Q4W, or 40,000 IU Q4W for 16 wk. Subjects were > or =18 yr, had hemoglobin <11 g/dl, a glomerular filtration rate of 15 to 90 ml/min per 1.73 m(2), and had not received erythropoietic therapy within 8 wk. The primary analysis was a noninferiority comparison of the 40,000 IU Q4W to the 20,000 IU Q2W group in the per-protocol population with respect to hemoglobin change from baseline to the end of study.

RESULTS:

Of 262 subjects randomized, 229 comprised the per-protocol population. Mean hemoglobin change from baseline for the 40,000 IU Q4W group (1.24 g/dl) was not inferior to the 20,000 IU Q2W group (1.11 g/dl) with the lower limit of 95% CI, -0.21 g/dl. In the QW, 20,000 IU Q2W, 20,000 IU Q4W, and 40,000 IU Q4W groups, 90%, 87%, 75%, and 86% of subjects, respectively, achieved a hemoglobin increase > or =1 g/dl. Serious adverse events were similar across all groups.

CONCLUSIONS:

Epoetin alfa can be initiated Q4W in anemic CKD subjects.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00212875.

PMID:
18400964
PMCID:
PMC2440274
DOI:
10.2215/CJN.05681207
[Indexed for MEDLINE]
Free PMC Article
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