title: Peginesatide for maintenance treatment of anemia in hemodialysis and nondialysis patients previously treated with darbepoetin alfa.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Hofstra North Shore-Long Island Jewish School of Medicine, Great Neck, NY 11021, USA. sfishbane@nshs.edu
authors.forename: Steven
authors.initials: S
authors.lastname: Fishbane
authors.forename: Simon D
authors.initials: SD
authors.lastname: Roger
authors.forename: Edouard
authors.initials: E
authors.lastname: Martin
authors.forename: Grant
authors.initials: G
authors.lastname: Runyan
authors.forename: Janet
authors.initials: J
authors.lastname: O'Neil
authors.forename: Ping
authors.initials: P
authors.lastname: Qiu
authors.forename: Francesco
authors.initials: F
authors.lastname: Locatelli
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D000068256:Darbepoetin alfa; D004305:Dose-Response Relationship, Drug; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage* / Q000009:adverse effects; D006435:Renal Dialysis; D016896:Treatment Outcome
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D010455:Peptides; D004921:Erythropoietin; D000068256:Darbepoetin alfa; C556270:peginesatide