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

This study has been completed.
Sponsor:
Collaborator:
AMAG Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Michael Auerbach MD, Auerbach Hematology Oncology Associates P C
ClinicalTrials.gov Identifier:
NCT01374919
First received: June 14, 2011
Last updated: March 13, 2014
Last verified: March 2014

June 14, 2011
March 13, 2014
June 2011
March 2012   (final data collection date for 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 ] [ Designated as safety issue: No ]
Percentage of participates with indicated increase in hemoglobin from baseline to week 4 and week 8
Efficacy of 1020 mg of ferumoxytol over 15 minutes. Repeat hemoglobin measuremenets will take place a four week visit. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
We expect this method of administration to be more efficacious than the previous 510 mg infusion currently approved
Complete list of historical versions of study NCT01374919 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Safety of total dose infusion of ferumoxytol in 15 minutes. Vital signs and observation will continue for 60 minutes after administration. 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 ] [ Designated as safety issue: Yes ]
A 15 minute infusion of ferumoxytol at 1020 mg is expected to be as safe or ever safer because of reduced rate of administration
Not Provided
Not Provided
 
Total Dose Infusion of Ferumoxytol(1020mg) in 15 Minutes for Iron Deficiency Anemia
Total Dose Infusion of Ferumoxytol (1020mg) in 15 Minutes for Iron Defeciency Anemia

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Iron Deficiency Anemia
Drug: ferumoxytol
IV administration of 1020 mg of ferumoxytol in 15 minutes
Other Name: Feraheme, intravenous iron, total dose infusion
ferumoxytol
IV administration of 1020 mg of ferumoxytol in 15 minutes
Intervention: Drug: ferumoxytol
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01374919
Ferumoxytol 1020
No
Michael Auerbach MD, Auerbach Hematology Oncology Associates P C
Auerbach Hematology Oncology Associates P C
AMAG Pharmaceuticals, Inc.
Principal Investigator: Michael Auerbach, MD Auerbach Hematology and Oncology
Auerbach Hematology Oncology Associates P C
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP