Health Condition 1: null- Subjects with Iron Deficiency Anemia based on laboratory tests and a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
Conditions
Interventions
Intervention1: Ferumoxytol: I.V. injection of ferumoxytol 510 mg (17 mL) at Baseline (Day 1) with a second dose 2 to 8 days after Dose 1, for a total cumulative dose of 1.02 g
Control Intervention1: P
Sponsors
AMAG Pharmaceuticals Inc Sponsor
ICON Clinical Research India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with IDA 2. Subjects who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used 3. Female subjects of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study
Exclusion criteria
Exclusion criteria: 1. History of allergy to IV iron 2. Allergy to two or more classes of drugs 3. Subjects on dialysis or with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 4. Female subjects who are pregnant or intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test 5. Hemoglobin </=7.0 g/dL 6. Serum ferritin level >600 ng/mL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin changesTimepoint: 5 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient reported outcomesTimepoint: 5 Weeks | — |
Countries
India
Contacts
Public ContactJohn Luke
Sr. Clinical Research Physician
Outcome results
None listed