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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374919
• Other study ID #: Ferumoxytol 1020
• Status: Completed
• Phase: N/A
• First received: June 14, 2011
• Last updated: March 13, 2014
• Start date: June 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2014
• Source: Auerbach Hematology Oncology Associates P C
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Drug:
• ferumoxytol
IV administration of 1020 mg of ferumoxytol in 15 minutes

Locations

Country	Name	City	State
United States	Auerbach Hematology and Oncology	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Auerbach Hematology Oncology Associates P C	AMAG Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes