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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Auerbach Hematology Oncology Associates P C
• Collaborator: AMAG Pharmaceuticals, Inc.
• Treatments: Ferrosoferric Oxide; Iron

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.