Treatment Retention and Hemoglobin Response During Darbepoetin Alfa and Recombinant Human Erythropoietin Beta Therapy in Children With CKD-Related Anemia: A Secondary Analysis of a Randomized Trial

Open Access

Abstract

Background: Erythropoiesis-stimulating agents are widely used for CKD-related anemia in children, but pediatric evidence regarding longer-term treatment retention remains limited. This secondary analysis evaluated treatment retention and hemoglobin response during darbepoetin alfa and recombinant human erythropoietin beta therapy. Methods & Materials: Data were analyzed from a multicenter, open-label, active-controlled randomized trial involving children aged 1-18 years with CKD-related anemia conducted at the Department of Pediatric Nephrology, Bangladesh Institute of Child Health and Dhaka Shishu (Children) Hospital, and the Department of Pediatric Nephrology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, from October 2019 to September 2020. Participants received either darbepoetin alfa or recombinant human erythropoietin beta and were evaluated over 48 weeks. Treatment retention was defined as continuation of the assigned ESA through the 48-week evaluation. Hemoglobin response was assessed using the reported aggregate association between mean hemoglobin concentration and treatment duration. Results: A total of 44 children were included, comprising 19 receiving darbepoetin alfa and 25 receiving recombinant human erythropoietin beta. Overall, 33 of 44 children (75.0%) continued the assigned ESA through 48 weeks. Retention was observed in 15 of 19 children (78.9%) receiving darbepoetin alfa and 18 of 25 (72.0%) receiving recombinant human erythropoietin beta. Eleven children (25.0%) discontinued treatment. Inadequate ESA response requiring transfusion accounted for 5 discontinuations, iron-related hypersensitivity associated with transfusion for 3, and missed or delayed dosing for more than 16 weeks for 3. Mean hemoglobin concentration showed a strong positive association with treatment duration in both groups, with r=0.845 (p=0.004) for darbepoetin alfa and r=0.801 (p=0.001) for recombinant human erythropoietin beta. Conclusion: Approximately three-quarters of children remained on their assigned ESA through 48 weeks, and higher mean hemoglobin concentrations were observed at later treatment time points with both regimens. No conclusion regarding comparative superiority can be made from these findings.