Iron Deficiency Anemia Clinical Trial
Official title:
Total Dose Infusion of Ferumoxytol (1020mg) in 15 Minutes for Iron Defeciency Anemia
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.
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. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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