De novo weekly and biweekly darbepoetin alfa dosing in pediatric patients with chronic kidney disease

Darbepoetin alfa is a commonly prescribed erythropoiesis-stimulating agent (ESA) for correcting anemia in pediatric chronic kidney disease (CKD) patients. However, little information exists on its use in ESA-na < ve patients. This study evaluated the efficacy and safety of darbepoetin alfa in pediatric patients initiating ESA therapy. One-hundred sixteen pediatric ESA-na < ve subjects (aged 1-18 years) with CKD stages 3-5D and hemoglobin (Hb) < 10 g/dl from 43 centers in the US, Europe, and Mexico were randomized by age (three groups) and dialysis status (yes vs. no) to receive darbepoetin alfa once weekly (QW) or every 2 weeks (Q2W) subcutaneously (not on dialysis and peritoneal dialysis subjects) and intravenously (hemodialysis subjects). The drug was titrated to achieve Hb levels of 10.0-12.0 g/dl over 25 weeks. Patient- and parent-reported health-related outcomes were measured by the Pediatric Quality of Life Inventory (PedsQL (TM)) in children ae<yen>2 years. In both groups, mean Hb concentrations increased to ae<yen>11.0 g/dl over the first 3 months of treatment and remained stable within the 10.0-12.0 g/dl target range. The median time to achieve hemoglobin ae<yen>10 g/dl was slightly longer for subjects < 12 years (QW and Q2W, both 28 days) vs. those ae<yen>12 years (23 and 22 days, respectively). Adverse event profiles were similar between groups, with QW, four (7%) and Q2W, five (9%). PedsQL (TM) scores showed modest increases. Darbepoetin alfa can be safely administered either QW or Q2W to ESA-na < ve pediatric patients with CKD-related anemia to achieve Hb targets of 10.0-12.0 g/dl.