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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01155388
First Posted: July 1, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155388


Locations
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: NCT01155388     History of Changes
Other Study ID Numbers: AMAG-FER-CKD-252
First Submitted: June 30, 2010
First Posted: July 1, 2010
Last Update Posted: October 12, 2017
Last Verified: September 2016

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

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Ferrosoferric Oxide
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions