| Peginesatide for Maintenance Treatment of Anemia in Hemodialysis and Nondialysis Patients Previously Treated with Darbepoetin Alfa. | |
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MedLine Citation:
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PMID: 23243269 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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BACKGROUND AND OBJECTIVES: Peginesatide (Omontys) is a novel, synthetic, PEGylated, peptide-based erythropoiesis-stimulating agent (ESA) that is designed to specifically stimulate the erythropoietin receptor. This study evaluated maintenance of hemoglobin levels in patients after conversion from darbepoetin alfa to once-monthly peginesatide. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This open-label, multicenter study included 101 CKD patients, 49 of whom were receiving dialysis. The duration of the study was 24 weeks. The primary endpoint was the mean change in hemoglobin from baseline to the evaluation period (weeks 19-24). The study was conducted during the period from September 22, 2008 to December 24, 2009. RESULTS: The mean change among hemodialysis patients was -0.42 g/dl (95% confidence interval, -0.65 to -0.19) and the mean change among CKD nondialysis patients was 0.49 g/dl (95% confidence interval, 0.26-0.71). The percentages of patients who maintained hemoglobin levels within ±1.0 g/dl of baseline values were as follows: 80.0% for hemodialysis and 68.1% for nondialysis, and73.3% for hemodialysis and 68.1% for nondialysis within the target range of 10.0-12.0 g/dl. Few patients received red blood cell transfusions (hemodialysis, 5.8%; nondialysis, 2.0%). Seventy-nine patients experienced adverse events, the majority of which were mild or moderate in severity. There were 40 serious adverse events and 2 deaths reported. CONCLUSIONS: In this study, once-monthly peginesatide resulted in a slight decrease in mean hemoglobin levels in individuals on hemodialysis and a small increase in individuals with CKD who were not on dialysis. |
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Authors:
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Steven Fishbane; Simon D Roger; Edouard Martin; Grant Runyan; Janet O'Neil; Ping Qiu; Francesco Locatelli |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-12-14 |
Journal Detail:
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Title: Clinical journal of the American Society of Nephrology : CJASN Volume: - ISSN: 1555-905X ISO Abbreviation: Clin J Am Soc Nephrol Publication Date: 2012 Dec |
Date Detail:
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Created Date: 2012-12-17 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101271570 Medline TA: Clin J Am Soc Nephrol Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Hofstra North Shore-Long Island Jewish School of Medicine, Great Neck, New York;, †Gosford Hospital, Gosford, New South Wales, Australia;, ‡South Florida Nephrology Associates, Lauderdale Lakes, Florida;, §Takeda Global Research & Development Center Inc, Deerfield, Illinois, ‖Department of Nephrology, Manzoni Hospital, Lecco, Italy. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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