Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Dextrans; Ferric Compounds; Ferric Oxide, Saccharated; Iron; Iron-Dextran Complex

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.