BACKGROUND AND OBJECTIVES: Peginesatide is a synthetic, PEGylated, 
investigational, peptide-based erythropoiesis-stimulating agent. We report the 
first assessment of its efficacy and safety in correcting renal anemia in a 
population of 139 nondialysis chronic kidney disease patients.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Chronic kidney disease patients 
who were not on dialysis and not receiving treatment with 
erythropoiesis-stimulating agents in the 12 weeks before study drug 
administration were sequentially assigned to one of 10 cohorts; cohorts differed 
in starting peginesatide dose (different body weight-based or absolute doses), 
route of administration (intravenous or subcutaneous), and frequency of 
administration (every 4 or 2 weeks).
RESULTS: Across all cohorts, 96% of patients achieved a hemoglobin response. A 
dose-response relationship was evident for hemoglobin increase. Comparable 
subcutaneous and intravenous peginesatide doses produced similar hemoglobin 
responses. Rapid rates of hemoglobin rise and hemoglobin excursions >13 g/dl 
tended to occur more frequently with every-2-weeks dosing than they did with 
every-4-weeks dosing. The range of final median doses in the every-4-weeks 
dosing groups was 0.019 to 0.043 mg/kg. Across all cohorts, 20% of patients 
reported serious adverse events (one patient had a possibly drug-related serious 
event) and 81% reported adverse events (11.5% reported possibly drug-related 
events); these events were consistent with those routinely observed in this 
patient population.
CONCLUSIONS: This study suggests that peginesatide administered every 4 weeks 
can increase and maintain hemoglobin in nondialysis chronic kidney disease 
patients. Additional long-term data in larger groups of patients are required to 
further elucidate the efficacy and safety of this peptide-based 
erythropoiesis-stimulating agent.