Document Detail

Peginesatide for maintenance treatment of anemia in hemodialysis and nondialysis patients previously treated with darbepoetin alfa.
MedLine Citation:
PMID:  23243269     Owner:  NLM     Status:  MEDLINE    
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, 52 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.
Steven Fishbane; Simon D Roger; Edouard Martin; Grant Runyan; Janet O'Neil; Ping Qiu; Francesco Locatelli
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2012-12-14
Journal Detail:
Title:  Clinical journal of the American Society of Nephrology : CJASN     Volume:  8     ISSN:  1555-905X     ISO Abbreviation:  Clin J Am Soc Nephrol     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-04-08     Completed Date:  2013-09-30     Revised Date:  2014-04-10    
Medline Journal Info:
Nlm Unique ID:  101271570     Medline TA:  Clin J Am Soc Nephrol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  538-45     Citation Subset:  IM    
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MeSH Terms
Aged, 80 and over
Anemia / blood,  drug therapy*,  etiology
Dose-Response Relationship, Drug
Erythropoietin / analogs & derivatives*,  therapeutic use
Hematinics / administration & dosage*,  adverse effects
Hemoglobins / metabolism
Kidney Failure, Chronic / complications*,  therapy
Middle Aged
Peptides / administration & dosage*,  adverse effects
Renal Dialysis*
Treatment Outcome
Reg. No./Substance:
0/Hematinics; 0/Hemoglobins; 0/Peptides; 0/peginesatide; 11096-26-7/Erythropoietin; 15UQ94PT4P/darbepoetin alfa

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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