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Published ahead of print on January 10, 2007
Clinical Journal of the American Society of Nephrology
© 2007 American Society of Nephrology
doi: 10.2215/CJN.02590706
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Received July 25, 2006
Accepted on November 30, 2006

ORIGINAL ARTICLES

Epoetin {alpha} Once Every 2 Weeks Is Effective for Initiation of Treatment of Anemia of Chronic Kidney Disease

Robert Benz *1, Rebecca Schmidt {dagger}, Kathleen Kelly {ddagger}, and Marsha Wolfson {ddagger}

*Division of Nephrology, Lankenau Hospital & Research Center, Wynnewood, Pennsylvania; {dagger}Section of Nephrology, West Virginia University School of Medicine, Morgantown, West Virginia; and {ddagger}Ortho Biotech Clinical Affairs, Bridgewater, New Jersey


1 To whom correspondence should be addressed. E-mail: benz{at}op.net.


   Abstract

There are limited data suggesting that initiation of epoetin {alpha} at extended dosing intervals of every 2, 3, or 4 wk may be efficacious for treating anemia in patients who have chronic kidney disease and are not on dialysis (CKD-NOD). This open-label, multicenter, single-arm study investigated the efficacy of administration of 20,000 IU of epoetin {alpha} once every 2 wk as initiation therapy in these patients. Adults with CKD-NOD were eligible when they had hemoglobin (Hb) <11 g/dl, GFR of 10 to 60 ml/min per 1.73 m2, and stable serum creatinine for the past 6 mo. Patients received 20,000 IU of epoetin {alpha} subcutaneously every 2 wk for up to 27 wk, with dosage adjustments permitted after 4 wk of treatment. The primary efficacy end point was the proportion of patients with Hb response, defined as achievement of the target Hb range of 11 to 12 g/dl for at least two consecutive visits. Sixty-seven patients were enrolled; >88% (59 of 67) of patients achieved an Hb response. Mean Hb increased to the targeted range by week 6 and remained in the range through week 28. Hb increases of 1 and 2 g/dl were observed in 91 and 78% of patients, respectively. Epoetin {alpha} was well tolerated; most adverse events were mild or moderate in nature and typical of the CKD patient population. In this study, results demonstrated that epoetin {alpha} can be initiated safely and effectively at an extended dosing interval of 20,000 IU every 2 wk in patients with CKD-NOD.




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