N/A
N=60
Total Dose Infusion of Ferumoxytol(1020mg) in 15 Minutes for Iron Deficiency Anemia
Iron Deficiency Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01374919 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit. — 85; 58; 92; 86 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ferumoxytol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Auerbach Hematology Oncology Associates P C
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit. |
85; 58; 92; 86 | — |
| 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. |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01374919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.