AzTrials
AzTrials

AnemiaPhase 3NCT00233597

Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients

A Phase 3 study testing ferumoxytol or oral iron in people with Anemia, run by AMAG Pharmaceuticals, Inc. at 50 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia
What is being tested?
ferumoxytol or oral iron
Type of treatment
Pill or oral medicine
How many people
230 participants
Where
50 sitesUnited States
Study dates
Aug 2004to Mar 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients ≥18 years.
  • Chronic hemodialysis.
  • Stable supplemental EPO therapy.
  • Baseline hemoglobin of ≤ 11.5 g/dl.

Who cannot join

  • Women who are pregnant or who are breast feeding.
  • Received another investigational drug or device within 30 days.
  • Recent parenteral or oral iron therapy.
  • Patients with active GI bleeding or acute bleeding within 4 weeks. Patients that have other causes of anemia.
  • Major surgery within 30 days or anticipated or planned surgery during the study.
  • Patients with active infections.
  • Recent blood transfusions.
  • Patients with known allergies to iron products.

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Alexandria, Virginia, 22304

  • Study site

    Appleton, Wisconsin, 54911

  • Study site

    Augusta, Georgia, 30901

  • Study site

    Austin, Texas, 78758

  • Study site

    Baton Rouge, Louisiana, 70809

  • Study site

    Bethesda, Maryland, 20814

  • Study site

    Boston, Massachusetts, 02135

  • Study site

    Brooklyn, New York, 11203

  • Study site

    Brooklyn, New York, 11212

  • Study site

    Brooklyn, New York, 11238

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Chesapeake, Virginia, 23320

  • Study site

    Columbus, Mississippi, 39705

  • Study site

    Corpus Christi, Texas, 78411

  • Study site

    Dallas, Texas, 75216

  • Study site

    Dallas, Texas, 75240

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Detroit, Michigan, 48236

  • Study site

    Fairfax, Virginia, 22030

  • Study site

    Flushing, New York, 11355

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Gurnee, Illinois, 60081

  • Study site

    Hines, Illinois, 60141

  • Study site

    Honolulu, Hawaii, 96817

  • Study site

    Houston, Texas, 77099

  • Study site

    Hudson, Florida, 34667

  • Study site

    Jackson, Mississippi, 39216

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Knoxville, Tennessee, 37923

  • Study site

    Lewistown, Pennsylvania, 17044

  • Study site

    Los Angeles, California, 90073

  • Study site

    Memphis, Tennessee, 38104

  • Study site

    Mineola, New York, 11501

  • Study site

    Mountain View, California, 94014

  • Study site

    New Haven, Connecticut, 06511

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10128

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    Orchard Park, New York, 14127

  • Study site

    Phoenix, Arizona, 85012

  • Study site

    Portland, Oregon, 97213

  • Study site

    Salem, Virginia, 24153

  • Study site

    Spokane, Washington, 99204

  • Study site

    Springfield, Massachusetts, 01107

  • Study site

    Springfield Gardens, New York, 11413

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Sumter, South Carolina, 29150

  • Study site

    Tampa, Florida, 33614

  • Study site

    Tempe, Arizona, 85284

Other trials in United States

About this study

Official title: A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Hemodialysis Patients Who Are Receiving Supplemental EPO Therapy

The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis.

Read the detailed description

This study will evaluate the efficacy and safety of intravenous (IV) iron (ferumoxytol) as compared to oral iron in the treatment of anemia in hemodialysis patients receiving erythropoietin. Patients are randomized to receive either two doses of 510 mg of intravenous ferumoxytol in sequential dialysis sessions or 200 mg oral elemental iron daily for three weeks.

Conditions
Anemia
Being tested
ferumoxytol or oral iron
Keywords
anemia, iron
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ferumoxytol or oral ironDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The mean change in hemoglobin from baseline.

Secondary outcomes (1)

  1. Change in iron indices.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2005 (estimated)
  2. Study startAug 2004
  3. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00233597
Sponsor's protocol ID
62745-5
Status last verified
Apr 2022
First submitted
4 Oct 2005
Last updated
4 Apr 2022
Results posted
No

Publications

  • Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK. Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005 Jul-Aug;25(4):400-10. doi: 10.1159/000087212. Epub 2005 Jul 28.

    PubMed 16088081

  • Provenzano R, Schiller B, Rao M, Coyne D, Brenner L, Pereira BJ. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009 Feb;4(2):386-93. doi: 10.2215/CJN.02840608. Epub 2009 Jan 28.

    PubMed 19176796

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ferumoxytol or oral iron in people with Anemia, run by AMAG Pharmaceuticals, Inc. at 50 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The mean change in hemoglobin from baseline.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00233597, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in