Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01114217
First received: April 29, 2010
Last updated: May 29, 2013
Last verified: May 2013

April 29, 2010
May 29, 2013
July 2010
September 2012   (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 NCT01114217 on ClinicalTrials.gov Archive Site
Patient reported outcomes [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01114217
AMAG-FER-IDA-303
Yes
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