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A Trial of Ferumoxytol for the Episodic 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-253 study as designed.)
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc. Identifier:
First received: December 20, 2010
Last updated: September 13, 2016
Last verified: September 2016
To evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (IDA) with ferumoxytol.

Condition Intervention Phase
The Episodic Treatment of Iron Deficiency Anemia in Pediatric Subjects With Chronic Kidney Disease
Drug: Ferumoxytol
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of the Safety and Efficacy of Ferumoxytol for the Episodic 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the pattern of recurrence of IDA [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: May 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


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

Key Inclusion Criteria include:

  1. Subjects who have completed participation in study AMAG-FER-CKD-251 or AMAG-FER-CKD-252 within the past 4 weeks
  2. Female subjects of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study
  3. Subject and/or legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study

Key Exclusion Criteria include:

  1. Experienced a serious adverse event (SAE) related to intravenous (IV) iron therapy in study AMAG-FER-CKD-251 or AMAG-FER-CKD-252
  2. Hemoglobin ≤7 g/dL
  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: NCT01264679

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: NCT01264679     History of Changes
Other Study ID Numbers: AMAG-FER-CKD-253 
Study First Received: December 20, 2010
Last Updated: September 13, 2016
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Mexico: Ministry of Health
Poland: Ministry of Health
Peru: Ministry of Health
Romania: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AMAG Pharmaceuticals, Inc.:
Iron deficiency anemia, Feraheme, ferumoxytol, CKD, pediatric, dialysis-dependent, pediatric nondialysis-dependent

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferrosoferric Oxide
Parenteral Nutrition Solutions
Pharmaceutical Solutions processed this record on January 14, 2017