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.