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
  Purpose

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 Intervention
Iron Deficiency Anemia
Drug: ferumoxytol

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Total Dose Infusion of Ferumoxytol (1020mg) in 15 Minutes for Iron Defeciency Anemia

Resource links provided by NLM:


Further study details as provided by Auerbach Hematology Oncology Associates P C:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Percentage of participates with indicated increase in hemoglobin from baseline to week 4 and week 8


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: June 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ferumoxytol
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374919

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

Publications:
Responsible Party: Michael Auerbach MD, Principal Investigator, 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

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

Additional relevant MeSH terms:
Anemia
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferumoxytol
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014