NCT01374919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 14, 2014

Completed
Last Updated

October 15, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

June 14, 2011

Results QC Date

March 18, 2013

Last Update Submit

September 30, 2025

Conditions

Iron Deficiency Anemia

Keywords

Intravenous ironferumoxytoliron deficiency anemiaTreatment of iron deficiencyIntolerance of or ineffectiveness of oral iron

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

ferumoxytol

OTHER

IV administration of 1020 mg of ferumoxytol in 15 minutes

Drug: ferumoxytol

Interventions

ferumoxytolDRUG

IV administration of 1020 mg of ferumoxytol in 15 minutes

Also known as: Feraheme, intravenous iron, total dose infusion
ferumoxytol

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auerbach Hematology and Oncology

Baltimore, Maryland, 21237, United States

Location

Related 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.

    PMID: 23828252RESULT

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsFerrous CompoundsMinerals

Results Point of Contact

Title
Dr. Michael Auerbach
Organization
Auerbach Hematology Oncology Assoc
mauerbachmd@abhemonc.com
410-780-4050

Study Officials

  • Michael Auerbach, MD

    Auerbach Hematology and Oncology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2011

First Posted

June 16, 2011

Study Start

June 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

October 15, 2025

Results First Posted

March 14, 2014

Record last verified: 2025-09

Locations

US(1)