Dose Requirement, Injection Burden, and Cost Implications of Darbepoetin Alfa Versus Recombinant Erythropoietin Beta in Children With CKD-Related Anemia

Open Access

Abstract

Introduction: Anemia is a common complication of chronic kidney disease (CKD) in children. Although darbepoetin alfa offers the advantage of less frequent dosing compared with recombinant human erythropoietin beta (rHuEPO beta), evidence regarding its effectiveness and safety in the pediatric population remains limited. Aim of the study: Anemia is a common complication of chronic kidney disease (CKD) in children. Although darbepoetin alfa offers the advantage of less frequent dosing compared with recombinant human erythropoietin beta (rHuEPO beta), evidence regarding its effectiveness and safety in the pediatric population remains limited. Methods & Materials: This multicenter, open-label, randomized controlled study was conducted in two pediatric nephrology centers in Dhaka, Bangladesh, from October 2019 to September 2020. Children aged 1 to 18 years with CKD-related anemia, including dialysis-independent CKD stages G3b to G5 and dialysis-dependent CKD G5d, were randomized to receive darbepoetin alfa or rHuEPO beta. Darbepoetin alfa was administered subcutaneously at 0.75 µg/kg/week with extended dosing intervals according to dialysis status, while rHuEPO beta was administered subcutaneously at 100 IU/kg three times weekly. The intention-to-treat (ITT) cohort included 44 children, and the per-protocol (PP) cohort included 33 children. Results: Darbepoetin alfa required fewer injections than rHuEPO beta, with a markedly lower monthly injection burden. Monthly darbepoetin alfa dose remained stable throughout the early treatment period, whereas the monthly rHuEPO beta dose increased. At 16 weeks, hemoglobin response was comparable between the treatment groups. At 48 weeks, the PP analysis demonstrated a higher mean hemoglobin level with darbepoetin alfa. Injection-site pain was reported more frequently with darbepoetin alfa, whereas the frequency of hypertension was similar between groups. Conclusion: Darbepoetin alfa provided a reduction in injection regimen while still having similar efficacy on the hemoglobin levels compared with those children with anemia caused by chronic kidney disease. Although the drug showed a better efficacy profile, further multicenter studies are still necessary. Keyword: Chronic kidney disease, Pediatric anemia, Darbepoetin alfa.