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

This study is currently recruiting participants.
Verified December 2012 by AMAG Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01155375
First received: June 28, 2010
Last updated: December 17, 2012
Last verified: December 2012
History of Changes

June 28, 2010
December 17, 2012
April 2011
April 2013   (final data collection date for primary outcome measure)
Hemoglobin changes [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01155375 on ClinicalTrials.gov Archive Site
Pharmacokinetic (PK) analysis [ Designated as safety issue: No ]
  • Maximum concentration (Cmax)
  • Area under the curve (AUC)
Same as current
Not Provided
Not Provided
 
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Subjects With Dialysis Dependent Chronic Kidney Disease
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 Dialysis Dependent Chronic Kidney Disease

To evaluate the efficacy and safety of IV ferumoxytol compared with oral iron for the treatment of pediatric subjects with dialysis-dependent chronic kidney disease.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Iron Deficiency Anemia
  • Drug: Ferumoxytol
    IV Ferumoxytol
  • Drug: Ferrous sulfate
    oral iron preparation
  • Active Comparator: Oral iron
    Oral iron
    Intervention: Drug: Ferrous sulfate
  • Experimental: Ferumoxytol
    Intravenous (IV) iron
    Intervention: Drug: Ferumoxytol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
October 2013
April 2013   (final data collection date for primary outcome measure)

Key Inclusion Criteria include:

  1. Males or females 6 months to <18 years of age
  2. On peritoneal dialysis or hemodialysis for ≥3 months prior to screening
  3. 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 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
Both
6 Months to 17 Years
No
Contact: William Strauss, MD 617-498-2893 pedstudyinfo@amagpharma.com
United States
 
NCT01155375
AMAG-FER-CKD-251
Yes
AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc.
Not Provided
Not Provided
AMAG Pharmaceuticals, Inc.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP