A Study to Characterize the Pharmacokinetics and Pharmacodynamics Profile of Intravenous Ferric Carboxymaltose in Pediatric Subjects 1-17 Years Old With Iron Deficiency Anemia (IDA)

This is a Phase II, open-label, non-randomized, multi-center, single arm study to
characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric
Carboxymaltose dosing in pediatric subjects with IDA after receiving either a 7.5 mg/kg or
15 mg/kg dose of Ferric Carboxymaltose.

Inclusion Criteria:

- Male or female subjects 1 to 17 years of age with assent to participation and his/her
parent or guardian is willing and able to sign the informed consent approved by the
Independent Review Board / Ethics Committee.

- Screening TSAT < 20%

- Screening Hemoglobin < 11 g/dL

- For subjects who are receiving an erythropoietin stimulating agent (ESA): stable ESA
therapy (+/- 20% of current dose) for > 8 weeks prior to the qualifying screening
visit and no ESA dosing or product changes anticipated for the length of the trial

Exclusion Criteria:

- Known hypersensitivity reaction to any component of Ferric Carboxymaltose.

- Subject previously randomized and treated in this study or any other clinical study
of Ferric Carboxymaltose (FCM or VIT-45).

- Body mass index (BMI) ≤ 5th percentile for age (see APPENDIX 2)

- Male or Female subject 1 year of age weighing < 12kg.

- History of acquired iron overload, hemochromatosis or other iron accumulation
disorders.

- Chronic kidney disease subjects on hemodialysis.

- Screening Ferritin level > 300ng/mL

- Subjects with significant severe diseases of the liver, hemopoietic system,
cardiovascular system, psychiatric disorder or other conditions which on the opinion
of the investigator may place a subject at added risk.

- Any active infection.

- Known positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with
evidence of active hepatitis.

- Known positive HIV-1/HIV-2 antibodies (anti-HIV).

- Anemia due to reasons other than iron deficiency (i.e. hemoglobinopathy). Subjects
treated with vitamin B12 or folic acid deficiency are permitted.

- Intravenous iron and /or blood transfusion in the 4 weeks prior to screening.

- Immunosuppressive therapy that may lead to anemia (i.e. cyclophosphamide,
azathioprine, mycophenolate mofetil). Note steroid therapy is permitted.

- Administration and / or use of an investigational product (drug or device) within 30
days of screening.

- Alcohol or drug abuse within the past six months.

- Female subjects who are pregnant or lactating, or sexually active female who are of
childbearing potential not willing to use an acceptable form of contraceptive
precautions during the study.

- Subject is unable to comply with study assessments.