Abstract
Background: Darbepoetin alfa (Aranesp; Amgen, Thousand Oaks, CA) is a new erythropoiesis-stimulating protein with a threefold longer terminal half-life than recombinant human erythropoietin (epoetin) in patients with chronic kidney disease (CKD). The purpose of this randomized, double-blind, noninferiority study is to determine whether darbepoetin alfa is as effective as epoetin for the treatment of anemia in hemodialysis patients when administered at a reduced dosing frequency. Methods: Patients receiving epoetin therapy were randomized to continue epoetin administered intravenously (IV) three times weekly (n = 338) or change to darbepoetin alfa administered IV once weekly (n = 169). The dose of darbepoetin alfa or epoetin was individually titrated to maintain hemoglobin concentrations within -1.0 to + 1.5 g/dL (-10 to + 15 g/L) of patients' baseline values and within a range of 9.0 to 13.0 g/dL (90 to 130 g/L) for up to 28 weeks (20-week dose-titration period followed by an 8-week evaluation period). The primary end point was change in hemoglobin level between baseline and the evaluation period (weeks 21 to 28). Results: Mean changes in hemoglobin levels from baseline to the evaluation period were 0.24 ± 0.10 (SE) g/dL (2.4 ± 1.0 g/L) in the darbepoetin alfa group and 0.11 ± 0.07 g/dL (1.1 ± 0.7 g/L) in the epoetin group, a difference of 0.13 g/dL (95% confidence interval CI], -0.08 ± 0.33 [1.3 g/L; 95% CI, -0.8 to 3.3]). This difference was not statistically significant or clinically relevant despite the reduced frequency of darbepoetin alfa administration. The safety profile of darbepoetin alfa was similar to that of epoetin, and no antibody formation to either treatment was detected. Conclusion: These results show that darbepoetin alfa maintains hemoglobin concentrations as effectively and safely as epoetin in patients with CKD, but with a reduced dosing frequency.
| Original language | English |
|---|---|
| Pages (from-to) | 110-118 |
| Number of pages | 9 |
| Journal | American Journal of Kidney Diseases |
| Volume | 40 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2002 |
| Externally published | Yes |
Bibliographical note
Funding Information:The United States and Canadian Aranesp ™ 980117 Study Group included the following members and institutions: Sharon Adler, Harbor-University of California at Los Angeles Medical Foundation, Torrance, CA; Michael Allon, Gambro Healthcare-Birmingham Central; Birmingham Acutes, Birmingham, AL; Paul Barre, Royal Victoria Hospital, Montreal, Quebec, Canada; William H. Bay, The Ohio State University Medical Center; Central Ohio Dialysis Center, Columbus, OH; Robert L. Benz, Lankenau Hospital/Research Center, Wynnewood; Bryn Mawr Hospital, Bryn Mawr, PA; Anatole Besarab, Henry Ford Hospital, Detroit, MI; W. Kline Bolton, University of Virginia Health Sciences Center, Charlottesville, VA; Borut Cizman, Lankenau Hospital/Research Center, Wynnewood; Bryn Mawr Hospital, Bryn Mawr, PA; Daniel W. Coyne, Washington University Medical Center; Barnes-Jewish Hospital, St Louis, MO; Mario Curzi, Diablo Renal Services, Walnut Creek and Antioch, CA; Joseph W. Eschbach, Northwest Kidney Centers, Seattle, WA; Adrian Fine, St Boniface General Hospital, Winnipeg, Manitoba, Canada; Steven Fishbane, The Dialysis Center, Mineola; The Dialysis Center at Bethpage, Bethpage, NY; Robert J. Goldstein, Florida West Coast Clinical Research; Gambro Central Dialysis, Tampa, FL; Gerald A. Hladik, Carolina Dialysis, Carrboro and Sanford, NC; David S. Hoffman, Biomedical Applications (BMA) South Miami; BMA West Kendal, Miami, FL; E. Ilamathi, St John's Episcopal Hospital, Smithtown, NY; Kailash Jindal, Victoria General Hospital, Halifax, Nova Scotia; Howard M. Karp, Shore Memorial Hospital, Sommers Point, NJ; James L. Katsikas, BMA South Miami; BMA West Kendall, Miami, FL; Charles J. Kaupke, University of California Irvine Medical Center, Orange, CA; Kenneth S. Kleinman; South Valley Regional Dialysis Center, Encino, CA; Jill S. Lindberg, Alton Ochsner Medical Foundation, New Orleans, LA; Jonathan Lorch, The Rogosin Institute, New York, NY; John P. MacLaurin, Doctors Hospital North; Grant Medical Center; Mount Carmel Health; Riverside Methodist Hospital, Columbus, OH; Peter Magner, Ottawa Civic Hospital, Ottawa, Ontario, Canada; Allen R. Nissenson, University of California at Los Angeles Medical Center, Los Angeles, CA; Deborah A. Price, West Suburban Artificial Kidney Center, Framingham, MA; Rasib M. Raja, BMA-Northeast (BMA-NE), Philadelphia, PA; Stephen Rifkin, Florida West Coast Clinical Research; Gambro Central Dialysis, Tampa, FL; Michael V. Rocco, Wake Forest University School of Medicine; Salem Kidney Center; Mt Airy Dialysis Center, Winston-Salem, NC; Jerald Sigala, St Joseph Hospital, Orange, CA; Marcia R. Silver, Farnsworth Ohio Renal Care Group, Cleveland, OH; William B. Smith, New Orleans Center for Clinical Research; Fresenius Medical Care; BMA Central New Orleans; Total Renal Care; Crescent City Dialysis; DCI Dialysis Unit, New Orleans, LA; S. Soroka, University of Alberta Hospitals, Edmonton, Alberta; David Spiegel, Gambro Healthcare Rocky Mountain Dialysis Center; Gambro Healthcare Central Denver Dialysis Center, Denver, CO; James A. Strom, St Elizabeth's Medical Center, Boston, MA; J.G. Sugihara, St Francis Medical Center; Queen's Medical Center Honolulu, HI; Suzanne K. Swan, Clinical Research Unit of Total Renal Research, Minneapolis, MN; Kant Tucker, Kidney Center of Simi Valley, Simi Valley; Kidney Center of Santa Paula, Santa Paula; Kidney Center of Van Nuys; Kidney Center of Panorama City, Panorama City, CA; David B. Van Wyck, Gambro Healthcare Patient Services, Tucson, AZ; Michael H. Walczyk, Pacific Northwest Renal Services; Legacy Hospital, Portland, OR; Barry Wilkes, North Shore University Hospital, Manhasset, NY; Barry C. Wood, Renal Care Group (RCG)-Saint Luke's Hospital, Kansas City; RCG-Harrisonville, Harrisonville, MO.
ASJC Scopus Subject Areas
- Nephrology
PubMed: MeSH publication types
- Clinical Trial
- Comparative Study
- Journal Article
- Multicenter Study
- Randomized Controlled Trial
- Research Support, Non-U.S. Gov't
