Total Dose Infusion of Ferumoxytol(1020mg) in 15 Minutes for Iron Deficiency Anemia

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. Identifier: NCT01374919
Recruitment Status : Completed
First Posted : June 16, 2011
Results First Posted : March 14, 2014
Last Update Posted : March 14, 2014
AMAG Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Michael Auerbach MD, Auerbach Hematology Oncology Associates P C

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Iron Deficiency Anemia
Intervention: Drug: ferumoxytol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from routine referrals from obgyns, gastroenterologists, bariatric surgeons, general internists and nephrologists. All patients were iron deficient and anemic. All were oral iron intolerant. The data were presented at the 2012 American Society of Hematology meeting.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Total Dose 1020 mg Feramoxytol All participants receive 1020 mg of Feramoxytol.

Participant Flow:   Overall Study
    Total Dose 1020 mg Feramoxytol
Withdrawal by Subject                2 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Total Dose 1020 mg Feramoxytol All participants receive 1020 mg of Feramoxytol.

Baseline Measures
   Total Dose 1020 mg Feramoxytol 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   42 
>=65 years   18 
[Units: Years]
Mean (Full Range)
 (22 to 89) 
[Units: Participants]
Female   48 
Male   12 
Region of Enrollment 
[Units: Participants]
United States   60 

  Outcome Measures

1.  Primary:   Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit.   [ Time Frame: baseline 4 weeks and 8 weeks ]

2.  Secondary:   Number of Participants With Treatment Related Serious Adverse Events. Calls for Minor Side Effects Will Occur at 24 and 48 Hours and One Week. A Followup Visit Will Occur at 4 Weeks.   [ Time Frame: immediate, 24 and 48 hours, one week and followup visit at 4 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Michael Auerbach
Organization: Auerbach Hematology Oncology Assoc
phone: 410-780-4050

Publications of Results:

Responsible Party: Michael Auerbach MD, Auerbach Hematology Oncology Associates P C Identifier: NCT01374919     History of Changes
Other Study ID Numbers: Ferumoxytol 1020
First Submitted: June 14, 2011
First Posted: June 16, 2011
Results First Submitted: March 18, 2013
Results First Posted: March 14, 2014
Last Update Posted: March 14, 2014