Clinical trial NCT01374919: 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
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Keywords: Intravenous iron
ferumoxytol
iron deficiency anemia
Treatment of iron deficiency
Intolerance of or ineffectiveness of oral iron
Lead sponsor: Auerbach Hematology Oncology Associates P C
Sponsor class: OTHER
Collaborators: name: AMAG Pharmaceuticals, Inc.
First posted: 2011-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit.
timeFrame: baseline 4 weeks and 8 weeks
Secondary outcomes:
measure: 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.
timeFrame: immediate, 24 and 48 hours, one week and followup visit at 4 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Auerbach Hematology and Oncology
state: Maryland
Study officials:
affiliation: Auerbach Hematology and Oncology
name: Michael Auerbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.