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Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01114217
First Posted: May 3, 2010
Last Update Posted: June 6, 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
June 6, 2013
July 2010
September 2012   (Final data collection date for primary outcome measure)
Hemoglobin changes
Same as current
Complete list of historical versions of study NCT01114217 on ClinicalTrials.gov Archive Site
Patient reported outcomes
Same as current
Not Provided
Not Provided
 
Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
A Phase III, Open-Label Extension Trial of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia (IDA).
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Iron Deficiency Anemia
Drug: Ferumoxytol
IV Ferumoxytol
Other Name: Feraheme
Experimental: Ferumoxytol
Safety and efficacy of intravenous (IV) ferumoxytol for the treatment of iron deficiency anemia (IDA)
Intervention: Drug: Ferumoxytol
Vadhan-Raj S, Ford DC, Dahl NV, Bernard K, Li Z, Allen LF, Strauss WE. Safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy: Results of a phase III, open-label, 6-month extension study. Am J Hematol. 2016 Feb;91(2):E3-5. doi: 10.1002/ajh.24240.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
634
May 2013
September 2012   (Final data collection date for primary outcome measure)

Key Inclusion Criteria include:

  1. Subjects who completed participation in study AMAG-FER-IDA-301
  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

Key Exclusion Criteria include:

  1. Experienced a serious adverse event (SAE) related to ferumoxytol in study AMAG-FER-IDA-301
  2. Female subjects who are pregnant, intend to become pregnant, are breastfeeding, or have a positive serum/urine pregnancy test
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
 
 
NCT01114217
AMAG-FER-IDA-303
Yes
Not Provided
Not Provided
AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc.
Not Provided
Not Provided
AMAG Pharmaceuticals, Inc.
May 2013

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