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

This study has been terminated.
(Study AMAG-FER-CKD-252 was combined with Study AMAG-FER-CKD-251 and is currently recruiting under study AMAG-FER-CKD-251.)
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc. Identifier:
First received: June 30, 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 nondialysis-dependent chronic kidney disease.

Condition Intervention Phase
Iron Deficiency Anemia Nondialysis Dependent Chronic Kidney Disease Drug: Ferumoxytol Drug: Ferrous sulfate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Nondialysis-dependent 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)

Enrollment: 7
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
Experimental: Ferumoxytol
Intravenous (IV) iron
Drug: Ferumoxytol
IV Ferumoxytol
Other Name: Feraheme
Active Comparator: Oral iron
Oral iron
Drug: Ferrous sulfate
Oral iron preparation


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. Nondialysis dependent CKD, including kidney transplant recipients
  3. Has IDA defined as: a) hemoglobin <11.0 g/dL and b) TSAT <20%
  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. Allergy to two or more classes of drugs
  3. Female subjects who are pregnant, intend to become pregnant, are breastfeeding, within 3 months postpartum, or have a positive serum/urine pregnancy test
  4. Hemoglobin ≤7.0 g/dL
  5. Serum ferritin >600 ng/mL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01155388

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: NCT01155388     History of Changes
Other Study ID Numbers: AMAG-FER-CKD-252
Study First Received: June 30, 2010
Last Updated: September 19, 2016

Keywords provided by AMAG Pharmaceuticals, Inc.:
Iron deficiency anemia
The treatment of iron deficiency anemia in pediatric subjects with nondialysis dependent 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
Ferrosoferric Oxide
Trace Elements
Growth Substances
Physiological Effects of Drugs
Parenteral Nutrition Solutions
Pharmaceutical Solutions processed this record on September 21, 2017