title: Peginesatide to Manage Anemia in Chronic Kidney Disease Patients on Peritoneal Dialysis.
abstract: ♦
  
  
  BACKGROUND
  Peginesatide is a novel, synthetic, peptide-based pegylated erythropoiesis-stimulating agent that is designed specifically to stimulate the erythropoietin receptor. The purpose of the present study was to assess, for the first time, the efficacy and safety of peginesatide in chronic kidney disease (CKD) patients receiving peritoneal dialysis (PD) and previously on epoetin treatment. ♦
  
  
  METHODS
  In this open-label multicenter study, 59 PD patients with CKD were converted from epoetin (alfa or beta) to once-monthly peginesatide. Doses were titrated to maintain hemoglobin levels between 10 g/dL and 12 g/dL during the 25 weeks of the study. The primary endpoint was change from baseline in mean hemoglobin values during the evaluation period (weeks 20 - 25). ♦
  
  
  RESULTS
  The mean hemoglobin value during the evaluation period was 11.3 ± 1.07 g/dL, and the mean change from baseline was 0.10 ± 1.15 g/dL (95% confidence limits: -0.24, 0.44 g/dL). During the evaluation period, most patients maintained hemoglobin levels between 10 g/dL and 12 g/dL (63.0%) and within ±1.0 g/dL of baseline (60.9%). The median weekly epoetin dose at baseline was 96.0 U/kg, and the median starting peginesatide dose was 0.047 mg/kg. Forty-three patients (72.9%) completed the study. Six patients (10.2%) received red blood cell transfusions. The observed adverse event profile was consistent with underlying conditions in the PD patient population. The most common adverse event was peritonitis (20.3%), a complication commonly associated with PD. Four deaths occurred during the study (2 related to septic shock, and 1 each to myocardial ischemia and myasthenia gravis). ♦
  
  
  CONCLUSIONS
  In this study, once-monthly peginesatide maintained hemoglobin levels in PD patients after conversion from epoetin.
authors.affiliation: Northwest Louisiana Nephrology, Shreveport, Louisiana, USA rz190@aol.com.
authors.forename: Raja
authors.initials: R
authors.lastname: Zabaneh
authors.affiliation: Department of Renal Medicine, Gosford Hospital, Gosford, New South Wales, Australia.
authors.forename: Simon D
authors.initials: SD
authors.lastname: Roger
authors.affiliation: University of Southern California, Los Angeles, California, USA.
authors.forename: Mohamed
authors.initials: M
authors.lastname: El-Shahawy
authors.affiliation: Renal Associates of Baton Rouge, Baton Rouge, Louisiana, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Roppolo
authors.affiliation: Takeda Development Center Americas, Deerfield, Illinois, USA.
authors.forename: Grant
authors.initials: G
authors.lastname: Runyan
authors.affiliation: Takeda Development Center Americas, Deerfield, Illinois, USA.
authors.forename: Janet
authors.initials: J
authors.lastname: O'Neil
authors.affiliation: Takeda Development Center Americas, Deerfield, Illinois, USA.
authors.forename: Ping
authors.initials: P
authors.lastname: Qiu
mesh_terms: D000740:Anemia / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006454:Hemoglobins / Q000187:drug effects; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D010455:Peptides / Q000627:therapeutic use*; D010530:Peritoneal Dialysis / Q000009:adverse effects* / Q000379:methods; D051436:Renal Insufficiency, Chronic / Q000175:diagnosis / Q000628:therapy*; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D006454:Hemoglobins; D010455:Peptides; C556270:peginesatide
keywords: Peginesatide; anemia; chronic kidney disease; erythropoiesis-stimulating agents