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Published ahead of print on September 17, 2009
Clin J Am Soc Nephrol 4: 1731-1740, 2009
© 2009 American Society of Nephrology
doi: 10.2215/CJN.03470509
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Chronic Kidney Disease

A Randomized Controlled Study of Weekly and Biweekly Dosing of Epoetin Alfa in CKD Patients With Anemia

Pablo E. Pergola*, Gary Gartenberg{dagger}, Min Fu{dagger}, Marsha Wolfson{ddagger}, Sudhakar Rao{dagger}, and Peter Bowers{dagger}

* Division of Nephrology, University of Texas Health Science Center and Renal Associates, PA, San Antonio, Texas; {dagger} Johnson & Johnson Pharmaceutical Research & Development, Raritan, New Jersey; {ddagger} Centocor Ortho Biotech Services, Horsham, Pennsylvania

Correspondence: Dr. Pablo E. Pergola,Renal Associates, PA, 215 East Quincy Street, Suite 610, San Antonio, TX 78215. Phone: 210-223–4444; Fax: 210-222-9031; E-mail: ppergola{at}raparesearch.com

Background and objectives: In clinical practice, physicians often use once-weekly (QW) and biweekly (Q2W) dosing of epoetin alfa to treat anemia in patients with chronic kidney disease (CKD). Although the literature supports this practice, previous studies were limited by short treatment duration, lack of randomization, or absence of the approved three times per week (TIW) dosing arm. This randomized trial evaluated extended dosing regimens of epoetin alfa, comparing QW and Q2W to TIW dosing in anemic CKD subjects. The primary objective was to show that treatment with epoetin alfa at QW and Q2W intervals was not inferior to TIW dosing.

Design, setting, participants, & measurements: 375 subjects with stage 3 to 4 CKD were randomized equally to the three groups and treated for 44 wk; to explore the impact of changing from TIW to QW administration on hemoglobin (Hb) control and adverse events, subjects on TIW switched to QW after 22 wk. The Hb was measured weekly, and the dose of epoetin alfa was adjusted to achieve and maintain an Hb level of 11.0 to 11.9 g/dl.

Results: Both the QW and Q2W regimens met the primary efficacy endpoint. More subjects in the TIW group than in the QW and Q2W groups exceeded the Hb ceiling. Adverse events were similar across treatment groups and consistent with the morbidities of CKD patients.

Conclusions: Administration of epoetin alfa at QW and Q2W intervals are potential alternatives to TIW dosing for the treatment of anemia in stage 3 to 4 CKD subjects.


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