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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by AMAG Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01155375
First received: June 28, 2010
Last updated: June 23, 2014
Last verified: June 2014

June 28, 2010
June 23, 2014
April 2011
March 2016   (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)
  • Half-life (t1/2)
Pharmacokinetic (PK) analysis [ Designated as safety issue: No ]
  • Maximum concentration (Cmax)
  • Area under the curve (AUC)
Not Provided
Not Provided
 
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Subjects With 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 Chronic Kidney Disease

To evaluate the efficacy and safety of IV ferumoxytol compared with oral iron for the treatment of pediatric subjects with 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 fumarate
    oral iron preparation
  • Active Comparator: Oral iron
    Oral iron
    Intervention: Drug: Ferrous fumarate
  • 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
288
March 2017
March 2016   (final data collection date for primary outcome measure)

Key Inclusion Criteria include:

  1. Males or females 6 months to <18 years of age
  2. CKD non-dialysis subjects or dialysis dependent subjects who are on peritoneal dialysis or stable hemodialysis prior to screening
  3. Has IDA defined as: a) hemoglobin ≤12.0 g/dL and b) with either TSAT ≤40% or ferritin <100 ng/mL
  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. Hemoglobin ≤7.0 g/dL
  3. Serum ferritin >600 ng/mL
  4. Female subjects who are pregnant or intend to become pregnant, or are breastfeeding, are within 3 months postpartum, or have a positive serum pregnancy test
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.
June 2014

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