A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects

Iron Deficiency Anemia (IDA)

Safety Endpoints: Incidence of adverse events of special interest (hypotension and hypersensitivity)., Incidence of serious adverse events (SAEs)., Incidence of severe adverse events (AEs)., Incidence of cardiovascular AEs (myocardial infarction, heart failure, moderate to severe hypertension, and hospitalization due to any cardiovascular cause)., Incidence of AEs leading to study drug discontinuation., Incidence of treatment emergent AEs (TEAEs)., Change in vital signs (BP, heart rate, respiration rate) and body temperature, and routine laboratory parameters (hematology, chemistry, and iron panel).

Efficacy Endpoints: Proportion of subjects achieving a Hgb increase of at least 0.5 g/dL from Baseline to Week 5., Proportion of subjects achieving a Hgb increase of at least 0.5 g/dL or TSAT increase of at least 10% from Baseline to Week 5., Proportion of subjects achieving a TSAT increase of at least 10% from Baseline to Week 5., Change in Hgb from Baseline to Week 5., Proportion of subjects achieving a Hgb increase of at least 1.0 g/dL from Baseline to Week 5., Change in TSAT from Baseline to Week 5., Proportion of subjects receiving blood transfusions during the study., Change in other markers of iron stores (e.g., serum ferritin and serum iron) from Baseline to Week 5., Pharmacokinetic Endpoints: Area Under the Curve (AUC)., Clearance., Distribution and elimination half-lives. All parameters will be obtained from the population model.

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Lithuania, Poland