Peginesatide for maintenance treatment of anemia in hemodialysis and nondialysis patients previously treated with darbepoetin alfa.
Clin J Am Soc Nephrol
; 8(4): 538-45, 2013 Apr.
Article
em En
| MEDLINE
| ID: mdl-23243269
ABSTRACT
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Peptídeos
/
Eritropoetina
/
Diálise Renal
/
Hematínicos
/
Anemia
/
Falência Renal Crônica
Tipo de estudo:
Clinical_trials
/
Etiology_studies
Limite:
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Clin J Am Soc Nephrol
Assunto da revista:
NEFROLOGIA
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Estados Unidos
País de publicação:
EEUU
/
ESTADOS UNIDOS
/
ESTADOS UNIDOS DA AMERICA
/
EUA
/
UNITED STATES
/
UNITED STATES OF AMERICA
/
US
/
USA