♦
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.