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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Total Dose Infusion of Ferumoxytol (1020mg) in 15 Minutes for Iron Defeciency Anemia

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Drug: ferumoxytol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ferumoxytol<br>IV administration of 1020 mg of ferumoxytol in 15 minutes | Drug: ferumoxytol<br>* IV administration of 1020 mg of ferumoxytol in 15 minutes<br>* Other names: Feraheme, intravenous iron, total dose infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit. | Percentage of participates with indicated increase in hemoglobin from baseline to week 4 and week 8 | baseline 4 weeks and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | immediate, 24 and 48 hours, one week and followup visit at 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravenous iron, ferumoxytol, iron deficiency anemia, Treatment of iron deficiency, Intolerance of or ineffectiveness of oral iron