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

Brief Summary:

The aim of the study is to recruit 30 patients who have been referred to Auerach Hematology Oncology Assoc. for the treatment of iron defeciency anemia with iv iron (Ferumoxytol 1020 mg) administered via infusion pump over 15 minutes.

To ascertain acute safety and tolerability of ferumoxytol during immediate post dosing observation period.

Assess additional safety profile and laboratory assessment at follow up visit and interim telephone follow up.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: ferumoxytol Not Applicable

Detailed Description:
Ferumoxytol, a modified iron dextran, which allows the rapid administration of IV iron without free iron release, was approved for a 510 mg injection to be administered in not less than 17 seconds. Although this represents a felicitous treatment for patients who come frequently, such as dialysis and chemotherapy patients, multiple publications suggest that full dose replacement is usually at the 1000 mg level. No studies extant are available with this dosing schedule for ferumoxytol. In this trial, iron deficient patients with hemoglobin levels of <11.0 grams per deciliter will be consented to received 1020 mg (two 510 mg vials) of ferumoxytol in 15 minutes. Vital signs will be performed at 5, 10, 15, 30 and 60 minutes. Followup phone calls for any clinical adverse events will be made at 24-48 hours and one week after administration. At four weeks follow-up hematologic and serologic (iron parameters) will be made along with a physician visit.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Total Dose Infusion of Ferumoxytol (1020mg) in 15 Minutes for Iron Defeciency Anemia
Study Start Date : June 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Arm Intervention/treatment
IV administration of 1020 mg of ferumoxytol in 15 minutes
Drug: ferumoxytol
IV administration of 1020 mg of ferumoxytol in 15 minutes
Other Name: Feraheme, intravenous iron, total dose infusion

Primary Outcome Measures :
  1. 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 ]
    Percentage of participates with indicated increase in hemoglobin from baseline to week 4 and week 8

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Iron deficiency anemia intolerant of or failure to respond to oral iron or condition where oral iron is known to be ineffective or harmful.
  • Subject must be able to be contacted at 24-48 hours after dose and come for followup at four weeks.
  • Subject must be capable of understanding informed consent
  • No other form of iron may be taken within four weeks of consent or for four weeks after treatment

Exclusion Criteria:

  • History of hypersensitivity to ferumoxytol.
  • Imminent dialysis.
  • Anemia due to other etiology.
  • Parenteral iron within 4 weeks of consent.
  • Pregnancy.
  • Erythropoiesis stimulating agent within 30 days of consent.
  • Other illness that would interfere with participation or understanding of trial.
  • Major surgery planned within four weeks of consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01374919

United States, Maryland
Auerbach Hematology and Oncology
Baltimore, Maryland, United States, 21237
Sponsors and Collaborators
Auerbach Hematology Oncology Associates P C
AMAG Pharmaceuticals, Inc.
Principal Investigator: Michael Auerbach, MD Auerbach Hematology and Oncology

Publications of Results:
Responsible Party: Michael Auerbach MD, Principal Investigator, Auerbach Hematology Oncology Associates P C Identifier: NCT01374919     History of Changes
Other Study ID Numbers: Ferumoxytol 1020
First Posted: June 16, 2011    Key Record Dates
Results First Posted: March 14, 2014
Last Update Posted: March 14, 2014
Last Verified: March 2014

Keywords provided by Michael Auerbach MD, Auerbach Hematology Oncology Associates P C:
Intravenous iron
iron deficiency anemia
Treatment of iron deficiency
Intolerance of or ineffectiveness of oral iron

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Ferrosoferric Oxide
Trace Elements
Growth Substances
Physiological Effects of Drugs
Parenteral Nutrition Solutions
Pharmaceutical Solutions