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A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Subjects With Chronic Kidney Disease

This study has been terminated.
(Several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the AMAG-FER-CKD-251 study as designed.)
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc. Identifier:
First received: June 28, 2010
Last updated: September 19, 2016
Last verified: September 2016
To evaluate the efficacy and safety of IV ferumoxytol compared with oral iron for the treatment of pediatric subjects with chronic kidney disease.

Condition Intervention Phase
Iron Deficiency Anemia
Drug: Ferumoxytol
Drug: Ferrous fumarate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Active-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of Ferumoxytol Compared With Oral Iron for the Treatment of Iron Deficiency Anemia in Pediatric Subjects With Chronic Kidney Disease

Resource links provided by NLM:

Further study details as provided by AMAG Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Hemoglobin changes

Secondary Outcome Measures:
  • Pharmacokinetic (PK) analysis
    • Maximum concentration (Cmax)
    • Area under the curve (AUC)
    • Half-life (t1/2)

Enrollment: 14
Study Start Date: April 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral iron
Oral iron
Drug: Ferrous fumarate
oral iron preparation
Experimental: Ferumoxytol
Intravenous (IV) iron
Drug: Ferumoxytol
IV Ferumoxytol


Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria include:

  1. Males or females 6 months to <18 years of age
  2. CKD non-dialysis subjects or dialysis dependent subjects who are on peritoneal dialysis or stable hemodialysis prior to screening
  3. Has IDA defined as: a) hemoglobin ≤12.0 g/dL and b) with either TSAT ≤40% or ferritin <100 ng/mL
  4. 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

Key Exclusion Criteria include:

  1. History of allergy to either oral or intravenous (IV) iron
  2. Hemoglobin ≤7.0 g/dL
  3. Serum ferritin >600 ng/mL
  4. Female subjects who are pregnant or intend to become pregnant, or are breastfeeding, are within 3 months postpartum, or have a positive serum pregnancy test
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Please refer to this study by its identifier: NCT01155375

United States, Massachusetts
AMAG Pharmaceuticals, Inc.
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
  More Information

Responsible Party: AMAG Pharmaceuticals, Inc. Identifier: NCT01155375     History of Changes
Other Study ID Numbers: AMAG-FER-CKD-251
Study First Received: June 28, 2010
Last Updated: September 19, 2016

Keywords provided by AMAG Pharmaceuticals, Inc.:
Iron deficiency anemia
non-dialysis dependent
The treatment of iron deficiency anemia in pediatric subjects with chronic kidney disease.

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Ferrous fumarate
Ferrosoferric Oxide
Trace Elements
Growth Substances
Physiological Effects of Drugs
Parenteral Nutrition Solutions
Pharmaceutical Solutions processed this record on May 22, 2017