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

This study is currently recruiting participants.
Verified December 2013 by AMAG Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01264679
First received: December 20, 2010
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264679

Contacts
Contact: William Strauss, MD 617-498-2893 pedstudyinfo@amagpharma.com

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

No publications provided

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: December 12, 2013
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:
Anemia
Kidney Diseases
Deficiency Diseases
Anemia, Iron-Deficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Ferumoxytol
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014