Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia

Who can take part

• Male and female participants 0 to 1 year of age, medically indicated for iron replacement, with his/her parent or legal guardian willing and able to sign the informed consent form approved by the IRB / Independent Ethics Committee (IEC)
• Screening Hb ≥7 g/dL to <10 g/dL
• Infants with any of the following conditions:; Heart failure with IDA defined as syndromes of excessive preload, excessive afterload, abnormal rhythm, or decreased contractility; Gastrointestinal diseases with acquired short bowel syndrome (due to volvulus, necrotizing enterocolitis from surgical resection or spontaneous intestinal perforation); Gastrointestinal intolerance of oral iron or an unsatisfactory response to oral iron; Other conditions associated with IDA which in the opinion of the investigator might benefit from administration of FCM

Who cannot take part

• Blood transfusion in the 4 weeks prior to consent
• Administration and / or use of an investigational product (drug or device) within 30 days of screening
• Known history of hypersensitivity reaction to FCM
• History of acquired iron overload, hemochromatosis, or other iron accumulation disorders
• Hemodialysis-dependent chronic kidney disease
• History of significant diseases of the liver, hematopoietic system, cardiovascular system, or other conditions which, on the opinion of the investigator, may place a participant at added risk for participation in the study
• Active infection
• Body weight <2.5 kg
• Anemia due to reasons other than iron deficiency (e.g., hemoglobinopathy vitamin B12 deficiency, or folic acid deficiency)
• Administration of an iron-containing product within 14 days of administration of the study article
• Current participation in another clinical trial
• Unable to comply with study procedures and assessments