Conditions: Iron Deficiency Anemia
Keywords: Intravenous iron ferumoxytol iron deficiency anemia Treatment of iron deficiency Intolerance of or ineffectiveness of oral iron
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 60
Healthy volunteers: yes

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.

Arms:
arm 1: IV administration of 1020 mg of ferumoxytol in 15 minutes

Interventions: intervention 1: ferumoxytol
Intervention descriptions: intervention 1: IV administration of 1020 mg of ferumoxytol in 15 minutes

Protocol document: