BACKGROUND: Limited prospective data are available on the long-term safety of darbepoetin alfa (DA) for treating anemia in children with chronic kidney disease (CKD). METHODS: In this prospective, phase IV, observational registry study, children ≤16 years of age with CKD anemia and receiving DA were observed for ≤2 years. Adverse events (AEs), DA dosing, hemoglobin (Hb) concentrations, and transfusions were recorded. RESULTS: A total of 319 patients were included in the analysis (mean age, 9.1 years), 158 (49.5%) of whom were on dialysis at study entry. Of 434 serious AEs reported in 162 children, the most common were peritonitis (10.0%), gastroenteritis (6.0%), and hypertension (4.1%). Six patients (1.9%) died (unrelated to DA). Four patients (1.3%) experienced six serious adverse drug reactions. The geometric mean DA dose range was 1.4-2.0 μg/kg/month. Mean baseline Hb concentration was 11.1 g/dl; mean values for children receiving and not receiving dialysis at baseline ranged between 10.9 and 11.5 g/dl and 11.2-11.7 g/dl, respectively. Overall, 48 patients (15.0%) received ≥1 transfusion. CONCLUSIONS: No new safety signals for DA were identified in children receiving DA for CKD anemia for ≤2 years. Based on Hb concentrations and transfusion requirements, DA was effective at managing anemia in these patients.

• MeSH
• Anemia blood   diagnosis   drug therapy   etiology   MeSH
• Biomarkers blood   MeSH
• Time Factors MeSH
• Renal Insufficiency, Chronic blood   complications   diagnosis   therapy   MeSH
• Darbepoetin alfa adverse effects   therapeutic use   MeSH
• Renal Dialysis * adverse effects   MeSH
• Child MeSH
• Hematinics adverse effects   therapeutic use   MeSH
• Hemoglobins metabolism   MeSH
• Infant MeSH
• Blood Transfusion MeSH
• Humans MeSH
• Adolescent MeSH
• Child, Preschool MeSH
• Prospective Studies MeSH
• Registries MeSH
• Risk Factors MeSH
• Age Factors MeSH
• Treatment Outcome MeSH
• Check Tag
• Child MeSH
• Infant MeSH
• Humans MeSH
• Adolescent MeSH
• Male MeSH
• Child, Preschool MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial, Phase IV MeSH
• Multicenter Study MeSH
• Observational Study MeSH
• Research Support, Non-U.S. Gov't MeSH
• Geographicals
• Europe MeSH