Overview

A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease

Status:
Terminated

Trial end date:
2014-06-24

Target enrollment:
0

Participant gender:
All

Summary

Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

AMAG Pharmaceuticals, Inc.

Treatments:

Ferrosoferric Oxide
Ferrous fumarate
Iron

Criteria

Key Inclusion Criteria for this study include:

1. Males or females 6 months to <18 years of age

2. Nondialysis dependent CKD, including kidney transplant recipients

3. Has iron deficiency anemia defined as: a) hemoglobin level <11.0 grams (g)/deciliter
(dL) and b) transferrin saturation level <20%

4. 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 participation in the study

Key Exclusion Criteria for this study include:

1. History of allergy to either oral or IV iron

2. Allergy to two or more classes of drugs

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

4. Hemoglobin level ≤7.0 g/dL

5. Serum ferritin level >600 nanograms/milliliter