HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) All Versions of this Article: CJN.05681207v1 3/4/1015    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Spinowitz, B. Search for Related Content PubMed PubMed Citation Articles by Spinowitz, B. Related Collections Related Articles

A Randomized Study of Extended Dosing Regimens for Initiation of Epoetin Alfa Treatment for Anemia of Chronic Kidney Disease

Bruce Spinowitz^*, Michael Germain, Robert Benz, Marsha Wolfson, Tracy McGowan, K. Linda Tang, Marc Kamin; for the Epoetin Alfa Extended Dosing Study Group

^* New York Hospital Queens, Flushing, New York; Western New England Renal & Transplant Associates, Inc, Springfield, Massachusetts; Division of Nephrology, Lankenau Hospital & Lankenau Institute for Medical Research, Wynnewood, Pennsylvania; and Ortho Biotech Clinical Affairs, LLC, Bridgewater, New Jersey

Correspondence: Dr. Bruce Spinowitz, New York Hospital Queens, 56-45 Main Street, Flushing, NY 11355. Phone: 718-670-1151; Fax: 718-353-9819; E-mail: bss9001{at}nyp.org

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 18 yr, had hemoglobin <11 g/dl, a glomerular filtration rate of 15 to 90 ml/min per 1.73 m², 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 1 g/dl. Serious adverse events were similar across all groups.

Conclusions: Epoetin alfa can be initiated Q4W in anemic CKD subjects.

Related Articles

Erythropoietin Stimulating Agents and Epoetin Alfa Revisited: What's Really Relevant?

Rowan G. Walker
Clin. J. Am. Soc. Nephrol. 2008 3: 935-937. [Full Text] [PDF]

This article has been cited by other articles:

				R. G. Walker Erythropoietin Stimulating Agents and Epoetin Alfa Revisited: What's Really Relevant? Clin. J. Am. Soc. Nephrol., July 1, 2008; 3(4): 935 - 937. [Full Text] [PDF]

				T. McGowan, N. M. Vaccaro, J. S. Beaver, J. Massarella, and M. Wolfson Pharmacokinetic and Pharmacodynamic Profiles of Extended Dosing of Epoetin Alfa in Anemic Patients Who Have Chronic Kidney Disease and Are Not on Dialysis Clin. J. Am. Soc. Nephrol., July 1, 2008; 3(4): 1006 - 1014. [Abstract] [Full Text] [PDF]