Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferric Carboxymaltose (FCM); Iron Sucrose / Iron Dextran
Intervention description: One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II); One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)
Intervention MeSH terms: Dextrans; Ferric Oxide, Saccharated; Iron-Dextran Complex
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare safety and the oxidative stress potential of two
      doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal single
      dose of IV iron sucrose or IV iron dextran in the treatment of Iron Deficiency Anemia (IDA)
      in female subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects 18-50 years of age and able to give informed consent.

          -  If post-partum, at least 10 days post delivery at Day 0.

          -  Screening Visit local laboratory Hgb < or = to 10 g/dL or < or = to 12 g/dL with
             symptoms (dizziness and/or fatigue).

          -  Screening Visit ferritin < or = to 100 ng/mL or < or = to 300 when TSAT is < or = to
             30%.

          -  Documented unsatisfactory response or intolerance to oral iron.

        Exclusion Criteria:

          -  Previous participation in a ferric carboxymaltose (FCM) clinical trial.

          -  Known hypersensitivity reaction to any component of ferric carboxymaltose, Venofer, or
             Dexferrum.

          -  History of drug allergy or any history of rheumatoid arthritis or other autoimmune
             diseases.

          -  Current anemia not attributed to iron deficiency.

          -  During the 10 day period prior to screening has been treated with antibiotics.

          -  During the 30 day period prior to screening or during the study period has or will be
             treated with erythropoiesis stimulating agents.

          -  Active malignancy within 5 years. Basal or squamous cell skin cancer is not
             exclusionary.

          -  During the 30 day period prior to screening or during the study period has or will
             require a surgical procedure that necessitates general anesthesia.

          -  Current (acute or chronic) infection other than viral upper respiratory tract
             infection.

          -  AST or ALT at screening greater than 1.5 times the upper limit of normal.

          -  Known positive hepatitis B with evidence of active hepatitis.

          -  Known positive HIV-1/HIV-2 antibodies (anti-HIV).

          -  Patient has an active diagnosis of asthma and is currently using an anti- asthmatic
             therapy.

          -  Received an investigational drug within 30 days of screening.

          -  Alcohol or drug abuse within the past 6 months.

          -  Hemochromatosis or other iron storage disorders.

          -  Systolic blood pressure > or = to 180 or < 80 mmHg or diastolic blood pressure > or =
             to 100 or < 40 mmHg at screening or Day 0.

          -  Chronic kidney disease.

          -  Chronic inflammatory condition including but not limited to Lupus and Rheumatoid
             Arthritis.

          -  Pre-term delivery < 32 weeks.

          -  Emergent C-section delivery.

          -  Significant cardiovascular disease, including but not limited to myocardial infarction
             or unstable angina within 6 months prior to study inclusion or current history of NYHA
             Class III or IV congestive heart failure.

          -  Any other laboratory abnormality, medical condition or psychiatric disorder which in
             the opinion of the investigator puts the subject's disease management at risk or may
             result in the subject being unable to comply with study requirements.

          -  Night shift workers.

          -  Breastfeeding planned on or after Day 0.

          -  Pregnant or sexually-active female subjects who are of childbearing potential and who
             don't use an acceptable form of contraception.