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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
First received: December 20, 2010
Last updated: September 15, 2014
Last verified: September 2014
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: Allocation: Non-Randomized
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 ]

Estimated Enrollment: 245
Study Start Date: May 2011
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2018 (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:   Both
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
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Please refer to this study by its ClinicalTrials.gov 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.
ClinicalTrials.gov Identifier: NCT01264679     History of Changes
Other Study ID Numbers: AMAG-FER-CKD-253 
Study First Received: December 20, 2010
Last Updated: September 15, 2014
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
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Ferrosoferric Oxide
Parenteral Nutrition Solutions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on August 23, 2016