A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease

• Status: Completed
• Trial end date: 2012-04-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).

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

Details

• Lead Sponsor: AMAG Pharmaceuticals, Inc.
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Iron

Criteria

Inclusion Criteria:

Key Inclusion Criteria include:

1. Males and females ≥18 years of age

2. An estimated glomerular filtration rate <60 mL/minute or a diagnosis of CKD (such as nephropathy, nephritis)

3. Hemoglobin <11.0 g/deciliter (dL)

4. Transferrin saturation <30%

5. Hemodialysis participants on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week

6. Female participants 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 the study

Exclusion Criteria:

Key Exclusion Criteria include:

1. History of allergy to IV iron

2. Allergy to 2 or more classes of drugs

3. Female participants who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test

4. Hemoglobin ≤7.0 g/dL

5. Received another investigational agent within 4 weeks prior to screening, or planned receipt of an unspecified investigational agent during the study period

6. Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12 or folate deficiency)