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

This study has been completed.
Sponsor:
Collaborator:
AMAG Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Michael Auerbach MD, Auerbach Hematology Oncology Associates P C
ClinicalTrials.gov Identifier:
NCT01374919
First received: June 14, 2011
Last updated: March 13, 2014
Last verified: March 2014
Results First Received: March 18, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Iron Deficiency Anemia
Intervention: Drug: ferumoxytol

  Participant Flow
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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
  Description
Total Dose 1020 mg Feramoxytol All participants receive 1020 mg of Feramoxytol.

Participant Flow:   Overall Study
    Total Dose 1020 mg Feramoxytol  
STARTED     60  
COMPLETED     58  
NOT COMPLETED     2  
Withdrawal by Subject                 2  



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

Baseline Measures
    Total Dose 1020 mg Feramoxytol  
Number of Participants  
[units: participants]
  60  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     42  
>=65 years     18  
Age  
[units: years]
Mean ( Full Range )
  53.4  
  ( 22 to 89 )  
Gender  
[units: participants]
 
Female     48  
Male     12  
Region of Enrollment  
[units: participants]
 
United States     60  



  Outcome Measures
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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
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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
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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
e-mail: mauerbachmd@abhemonc.com


Publications of Results:

Responsible Party: Michael Auerbach MD, Auerbach Hematology Oncology Associates P C
ClinicalTrials.gov Identifier: NCT01374919     History of Changes
Other Study ID Numbers: Ferumoxytol 1020
Study First Received: June 14, 2011
Results First Received: March 18, 2013
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration