Intravenous (IV) Versus Oral Iron Treatment of Iron Deficiency Anemia in the Post-operative Bariatric Surgical Patient

• Status: Withdrawn
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to compare two accepted treatments for iron deficiency anemia (oral ferrous sulfate and intravenous ferumoxytol) for efficacy and speed of response in the treatment of iron deficiency anemia (IDA) in the post-operative bariatric surgical patient. In this study, 104 bariatric surgical post-operative patients will be randomly assigned 52 each to oral or 52 to a single dose IV iron treatment using double-blind procedures.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: AMAG Pharmaceuticals, Inc.
• Treatments: Ascorbic Acid; Ferrosoferric Oxide; Iron; Vitamins

Criteria

Inclusion Criteria:

• Aged ≥ 18 years

• Patients who have undergone a Roux-en Y Gastric Bypass or Vertical Sleeve Gastrectomy and are at least 3 months or more out from surgery.

• Iron deficiency anemia defined as iron deficient with either ferritin < 20 mcg/l, transferrin saturation (TSAT) < 19%, or anemia with Hgb < 13 g/dL for both males and females.

• Willingness to use contraceptive to avoid pregnancy: Women have to be surgically sterile, post menopausal or use one of the following contraceptives during the whole study period and after the study has ended for at least five times the plasma biological half-life of the investigational medicinal product: intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, or injections with prolonged release).

• Willingness to participate and signing the informed consent form.

Exclusion Criteria:

• Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis)

• Decompensated liver cirrhosis or active hepatitis (ALT > 3 times upper limit of normal)

• Serum ferritin > 500 ng/mL or transferrin saturation > 40%

• Active acute or chronic infections (assessed by clinical judgment that may be indicated by White Blood Cells (WBC) and C-Reactive Protein (CRP) when these are available)

• Rheumatoid arthritis with symptoms or signs of active inflammation

• Pregnant and nursing women

• History of multiple allergies

• Known hypersensitivity to ferumoxytol or oral iron or any excipients in the drug products

• Previous IV iron treatment for IDA

• Other iron treatment or blood transfusion within 4 weeks prior to the screening or treatment visit

• Planned elective surgery during the study

• Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. a malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus