Back to resultsTotal Dose Infusion of Ferumoxytol(1020mg) in 15 Minutes for Iron Deficiency Anemia
Primary Purpose
Iron Deficiency Anemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ferumoxytol
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring Intravenous iron, ferumoxytol, iron deficiency anemia, Treatment of iron deficiency, Intolerance of or ineffectiveness of oral iron
Eligibility 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.
Sites / Locations
- Auerbach Hematology and Oncology
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ferumoxytol
Arm Description
IV administration of 1020 mg of ferumoxytol in 15 minutes
Outcomes
Primary Outcome Measures
Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit.
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.
Full Information
NCT ID
NCT01374919
First Posted
June 14, 2011
Last Updated
March 13, 2014
Sponsor
Auerbach Hematology Oncology Associates P C
Collaborators
AMAG Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01374919
Brief Title
Total Dose Infusion of Ferumoxytol(1020mg) in 15 Minutes for Iron Deficiency Anemia
Official Title
Total Dose Infusion of Ferumoxytol (1020mg) in 15 Minutes for Iron Defeciency Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auerbach Hematology Oncology Associates P C
Collaborators
AMAG Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
Intravenous iron, ferumoxytol, iron deficiency anemia, Treatment of iron deficiency, Intolerance of or ineffectiveness of oral iron
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ferumoxytol
Arm Type
Other
Arm Description
IV administration of 1020 mg of ferumoxytol in 15 minutes
Intervention Type
Drug
Intervention Name(s)
ferumoxytol
Other Intervention Name(s)
Feraheme, intravenous iron, total dose infusion
Intervention Description
IV administration of 1020 mg of ferumoxytol in 15 minutes
Primary Outcome Measure Information:
Title
Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit.
Description
Percentage of participates with indicated increase in hemoglobin from baseline to week 4 and week 8
Time Frame
baseline 4 weeks and 8 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Auerbach, MD
Organizational Affiliation
Auerbach Hematology and Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auerbach Hematology and Oncology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23828252
Citation
Auerbach M, Strauss W, Auerbach S, Rineer S, Bahrain H. Safety and efficacy of total dose infusion of 1,020 mg of ferumoxytol administered over 15 min. Am J Hematol. 2013 Nov;88(11):944-7. doi: 10.1002/ajh.23534. Epub 2013 Sep 9.
Results Reference
result
Learn more about this trial
Total Dose Infusion of Ferumoxytol(1020mg) in 15 Minutes for Iron Deficiency Anemia
We'll reach out to this number within 24 hrs