Introduction
CKD, chronic kidney disease, nutritional deficiency, anemia, PD, disability
IRON DEFICIENCY, MALABSORPTION, NUTRITIONAL DEFICIENCY, ADVERSE EVENTS, ANEMIA, SEVERE ANEMIA
Iron deficiency is the world’s most common nutritional deficiency affecting children, the primary cause of anemia globally, and an important factor contributing to ongoing disability.Correction of IDA in pediatric patients involves iron supplementation, which may be administered by oral or parenteral routes.Intravenous (IV) iron formulations circumvent malabsorption, facilitate rapid repletion of iron stores and hemoglobin levels, and have the potential to correct anemia after a single dose.Newer formulations that do not contain HMW dextran are much safer, with estimated serious adverse events rates of <1:250,000 administrations,A substantial proportion of the pediatric literature on the treatment of severe anemia is derived from studies in children with chronic kidney disease (CKD).The most commonly used IV iron preparation in pediatric patients, iron sucrose, has a recommended maximum single dose for iron maintenance treatment that should not exceed 100 mg and should be infused over 5 to 60 min in pediatric patients with CKD who are receiving hemodialysis or erythropoietin therapy, with no established dosing for iron replacement treatment.The labels for several newer iron preparations allow for the administration of higher doses of iron in adults, for example, ferumoxytol (510 mg over at least 15 min),Studies of the safety, effectiveness, and optimal dosing of newer iron products in pediatric patients are required in order to allow access to these products. FCM is a stable Type I polynuclear iron (III) hydroxide carbohydrate complex that was developed as an IV iron replacement therapy and is widely available for the treatment of IDA.The objectives of this Phase 2 study were to characterize the safety profile, pharmacokinetics (PK), and pharmacodynamics (PD) of single parenteral doses of FCM and to determine appropriate dosing in pediatric patients with IDA.