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  • Title: A randomized study of extended dosing regimens for initiation of epoetin alfa treatment for anemia of chronic kidney disease.
    Author: Spinowitz B, Germain M, Benz R, Wolfson M, McGowan T, Tang KL, Kamin M, Epoetin Alfa Extended Dosing Study Group.
    Journal: Clin J Am Soc Nephrol; 2008 Jul; 3(4):1015-21. PubMed ID: 18400964.
    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.
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