CompletedNot Applicable

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

United States60 participantsStarted 2011-06

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit.

Timeframe: baseline 4 weeks and 8 weeks

Trial details

NCT IDNCT01374919

SponsorAuerbach Hematology Oncology Associates P C

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03

Results submitted2013-03-18

View on ClinicalTrials.gov More Iron Deficiency Anemia trials