Expired Study
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Baltimore, Maryland 21237


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

Ferumoxytol 1020


NCT ID:

NCT01374919


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Auerbach Hematology Oncology Associates P C


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, In


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael Auerbach, MD
Principal Investigator
Auerbach Hematology and Oncology

Study Dates

Start Date:June 2011
Completion Date:March 2012
Completion Type:Actual
Primary Completion Date:March 2012
Primary Completion Type:Actual
Verification Date:March 2014
Last Changed Date:March 13, 2014
First Received Date:June 14, 2011
First Results Date:March 18, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit.
Time Frame:baseline 4 weeks and 8 weeks
Safety Issues:False
Description:Percentage of participates with indicated increase in hemoglobin from baseline to week 4 and week 8
Outcome Type:Secondary Outcome
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.
Time Frame:immediate, 24 and 48 hours, one week and followup visit at 4 weeks
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:ferumoxytol
Description:IV administration of 1020 mg of ferumoxytol in 15 minutes
Arm Name:ferumoxytol
Other Name:Feraheme, intravenous iron, total dose infusion

Study Arms

Study Arm Type:Other
Arm Name:ferumoxytol
Description:IV administration of 1020 mg of ferumoxytol in 15 minutes

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Auerbach Hematology Oncology Associates P C
Agency Class:Industry
Agency Type:Collaborator
Agency Name:AMAG Pharmaceuticals, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.
PMID:23828252

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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