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A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01114204
First Posted: May 3, 2010
Last Update Posted: April 10, 2013
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.
April 29, 2010
May 3, 2010
April 10, 2013
June 2010
November 2011   (Final data collection date for primary outcome measure)
Hemoglobin changes
Same as current
Complete list of historical versions of study NCT01114204 on ClinicalTrials.gov Archive Site
Patient reported outcomes
Same as current
Not Provided
Not Provided
 
A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
A Phase III, Randomized, Open-label, Active-Controlled, Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
The purpose of the study is to evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Iron Deficiency Anemia
  • Drug: Ferumoxytol
    IV Ferumoxytol
    Other Name: Feraheme
  • Drug: Iron Sucrose
    IV Iron Sucrose
    Other Name: Venofer
  • Experimental: Ferumoxytol
    Intravenous (IV) iron
    Intervention: Drug: Ferumoxytol
  • Active Comparator: Iron Sucrose
    Other intravenous (IV) iron
    Intervention: Drug: Iron Sucrose

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
605
June 2012
November 2011   (Final data collection date for primary outcome measure)

Key Inclusion Criteria include:

  1. Males and females ≥18 years of age
  2. Subjects with IDA
  3. Subjects who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
  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 IV iron
  2. Allergy to two or more classes of drugs
  3. Subjects on dialysis or with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
  4. Female subjects who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
  5. Hemoglobin ≤7.0 g/dL
  6. Serum ferritin >600 ng/mL
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01114204
AMAG-FER-IDA-302
Yes
Not Provided
Not Provided
AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc.
Not Provided
Not Provided
AMAG Pharmaceuticals, Inc.
April 2013

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