| Randomized, controlled trial of darbepoetin alfa for the treatment of anemia in hemodialysis patients. | |
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MedLine Citation:
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PMID: 12087568 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Allen R Nissenson; Suzanne K Swan; Jill S Lindberg; Steven D Soroka; Robert Beatey; Chao Wang; Nancy Picarello; Anna McDermott-Vitak; Bradley J Maroni |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: American journal of kidney diseases : the official journal of the National Kidney Foundation Volume: 40 ISSN: 1523-6838 ISO Abbreviation: Am. J. Kidney Dis. Publication Date: 2002 Jul |
Date Detail:
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Created Date: 2002-06-27 Completed Date: 2002-07-17 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8110075 Medline TA: Am J Kidney Dis Country: United States |
Other Details:
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Languages: eng Pagination: 110-8 Citation Subset: IM |
Copyright Information:
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Copyright 2002 by the National Kidney Foundation, Inc. |
Affiliation:
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University of California at Los Angeles Medical Center, Los Angeles, CA 90095, USA. anissenson@mednet.ucla.edu |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Anemia / drug therapy* Canada Double-Blind Method Drug Administration Schedule Epoetin Alfa / administration & dosage, adverse effects, therapeutic use Erythropoiesis / drug effects Erythropoietin / administration & dosage, adverse effects, analogs & derivatives, therapeutic use* Female Humans Injections, Intravenous Male Middle Aged Renal Dialysis* / methods Treatment Outcome United States |
| Chemical | |
Reg. No./Substance:
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11096-26-7/Erythropoietin; 113427-24-0/Epoetin Alfa; 209810-58-2/darbepoetin alfa |
| Comments/Corrections | |
Comment In:
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Am J Kidney Dis. 2003 Jun;41(6):1334; author reply 1334-5
[PMID:
12776288
]
Am J Kidney Dis. 2002 Oct;40(4):872 [PMID: 12324929 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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