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

NCT ID: NCT01374919

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-03-31

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.

Conditions

Iron Deficiency Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ferumoxytol

IV administration of 1020 mg of ferumoxytol in 15 minutes

Group Type: OTHER

ferumoxytol

Intervention Type: DRUG

IV administration of 1020 mg of ferumoxytol in 15 minutes

Interventions

ferumoxytol

IV administration of 1020 mg of ferumoxytol in 15 minutes

Intervention Type: DRUG

Other Intervention Names

Feraheme, intravenous iron, total dose infusion

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AMAG Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Auerbach Hematology Oncology Associates P C

OTHER

Sponsor Role: lead

Responsible Party

Michael Auerbach MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Auerbach, MD

Role: PRINCIPAL_INVESTIGATOR

Auerbach Hematology and Oncology

Locations

Auerbach Hematology and Oncology

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23828252 (View on PubMed)

Other Identifiers

Ferumoxytol 1020

Identifier Type: -

Identifier Source: org_study_id