AzTrials
AzTrials

Iron Deficiency AnemiaPhase 3NCT01114217

A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

A Phase 3 study testing Ferumoxytol in people with Iron Deficiency Anemia, run by AMAG Pharmaceuticals, Inc. at 140 sites in 6 countries.

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

To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia (IDA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Iron Deficiency Anemia
What is being tested?
Ferumoxytol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
634 participants
Where
140 sitesin 6 countries
Study dates
27 Jul 2010to 23 Apr 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participants who completed participation in study AMAG-FER-IDA-301 [NCT01114139]
  • Female participants of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study

Who cannot join

  • Experienced a serious adverse event (SAE) related to ferumoxytol in study AMAG-FER-IDA-301
  • Female participants who are pregnant, intend to become pregnant, are breastfeeding, or have a positive serum/urine pregnancy test

Trial locations and contacts

140 sites in 6 countries.

140 sites in 6 countries

United States103 sites

  • Clinical Trial Site

    Albuquerque, New Mexico

  • Clinical Trial Site

    Anaheim, California

  • Clinical Trial Site

    Arlington, Texas

  • Clinical Trial Site

    Atlanta, Georgia, 30308

  • Clinical Trial Site

    Atlanta, Georgia, 30312

  • Clinical Trial Site

    Atlanta, Georgia, 30342

  • Clinical Trial Site

    Aurora, Illinois

  • Clinical Trial Site

    Bakersfield, California

  • Clinical Trial Site

    Bay City, Michigan, 48706

  • Clinical Trial Site

    Bay City, Michigan

  • Clinical Trial Site

    Bethesda, Maryland

  • Clinical Trial Site

    Birmingham, Alabama

  • Clinical Trial Site

    Boynton Beach, Florida, 33426

  • Clinical Trial Site

    Boynton Beach, Florida, 33472

  • Clinical Trial Site

    Bristol, Connecticut

  • Clinical Trial Site

    Brooklyn, New York

  • Clinical Trial Site

    Buena Park, California

  • Clinical Trial Site

    Canton, Ohio

  • Clinical Trial Site

    Carlisle, Ohio

  • Clinical Trial Site

    Chesapeake, Virginia

  • Clinical Trial Site

    Chicago, Illinois, 60616

  • Clinical Trial Site

    Cincinnati, Ohio, 45224

  • Clinical Trial Site

    Cincinnati, Ohio, 45242

  • Clinical Trial Site

    Clearwater, Florida, 33756

  • Clinical Trial Site

    Clearwater, Florida, 33759

  • Clinical Trial Site

    Colton, California

  • Clinical Trial Site

    Columbia, South Carolina

  • Clinical Trial Site

    Columbus, Ohio, 43231

  • Clinical Trial Site

    Dallas, Texas

  • Clinical Trial Site

    Decatur, Georgia

  • Clinical Trial Site

    Dublin, Georgia

  • Clinical Trial Site

    Greer, South Carolina

  • Clinical Trial Site

    Groton, Connecticut

  • Clinical Trial Site

    Hialeah, Florida

  • Clinical Trial Site

    Holiday, Florida

  • Clinical Trial Site

    Hollywood, Maryland

  • Clinical Trial Site

    Houston, Texas, 77030

  • Clinical Trial Site

    Houston, Texas, 77074

  • Clinical Trial Site

    Houston, Texas

  • Clinical Trial Site

    Inverness, Florida

  • Clinical Trial Site

    Jenkintown, Pennsylvania

  • Clinical Trial Site

    Kansas City, Missouri

  • Clinical Trial Site

    Laredo, Texas

  • Clinical Trial Site

    Las Vegas, Nevada

  • Clinical Trial Site

    Lawrenceville, New Jersey

  • Clinical Trial Site

    Levittown, Pennsylvania

  • Clinical Trial Site

    Longview, Texas

  • Clinical Trial Site

    Los Angeles, California, 90036

  • Clinical Trial Site

    Los Angeles, California, 90057

  • Clinical Trial Site

    Los Angeles, California

  • Clinical Trial Site

    Margate, Florida

  • Clinical Trial Site

    Marion, Ohio, 43302

  • Clinical Trial Site

    Marion, Ohio

  • Clinical Trial Site

    Mentor, Ohio

  • Clinical Trial Site

    Miami, Florida, 33126

  • Clinical Trial Site

    Miami, Florida, 33135

  • Clinical Trial Site

    Miami, Florida, 33143

  • Clinical Trial Site

    Miami, Florida, 33144

  • Clinical Trial Site

    Miami, Florida, 33175

  • Clinical Trial Site

    Miami Lakes, Florida

  • Clinical Trial Site

    Middletown, Ohio

  • Clinical Trial Site

    Mission Hills, California

  • Clinical Trial Site

    Mobile, Alabama

  • Clinical Trial Site

    Montgomery, Alabama, 36106

  • Clinical Trial Site

    Montgomery, Alabama, 36116

  • Clinical Trial Site

    Myrtle Beach, South Carolina

  • Clinical Trial Site

    Naples, Florida

  • Clinical Trial Site

    Neptune City, New Jersey

  • Clinical Trial Site

    New Orleans, Louisiana

  • Clinical Trial Site

    New York, New York, 10038

  • Clinical Trial Site

    Norfolk, Virginia

  • Clinical Trial Site

    Norman, Oklahoma

  • Clinical Trial Site

    North Charleston, South Carolina

  • Clinical Trial Site

    Orange, California

  • Clinical Trial Site

    Orem, Utah

  • Clinical Trial Site

    Phoenix, Arizona, 85015

  • Clinical Trial Site

    Phoenix, Arizona, 85032

  • Clinical Trial Site

    Plainsboro, New Jersey

  • Clinical Trial Site

    Pueblo, Colorado

  • Clinical Trial Site

    Raleigh, North Carolina

  • Clinical Trial Site

    Rapid City, South Dakota

  • Clinical Trial Site

    San Antonio, Texas, 78205

  • Clinical Trial Site

    San Antonio, Texas, 78215

  • Clinical Trial Site

    San Antonio, Texas, 78229

  • Clinical Trial Site

    San Antonio, Texas

  • Clinical Trial Site

    San Diego, California, 92103

  • Clinical Trial Site

    San Diego, California, 92121

  • Clinical Trial Site

    San Diego, California, 92123

  • Clinical Trial Site

    Sandy Springs, Georgia

  • Clinical Trial Site

    Skokie, Illinois, 60076

  • Clinical Trial Site

    Skokie, Illinois

  • Clinical Trial Site

    Springfield, Illinois

  • Clinical Trial Site

    Stockbridge, Georgia

  • Clinical Trial Site

    Tucson, Arizona, 85710

  • Clinical Trial Site

    Tucson, Arizona, 85712

  • Clinical Trial Site

    Vero Beach, Florida

  • Clinical Trial Site

    Voorhees Township, New Jersey

  • Clinical Trial Site

    West Palm Beach, Florida

  • Clinical Trial Site

    Wichita, Kansas

  • Clinical Trial Site

    Winston-Salem, North Carolina

  • Clinical Trial Site

    Wyoming, Michigan

  • Clinical Trial Site

    Zanesville, Ohio

  • Clinical Trial Site

    Zephyrhills, Florida

Other trials in United States

India14 sites

  • Clinical Trial Site

    Bangalore, Karnataka, 560002

  • Clinical Trial Site

    Bangalore, Karnataka, 560054

  • Clinical Trial Site

    Chennai, Tamil Nadu

  • Clinical Trial Site

    Chhatrapati Sambhajinagar, Maharashtra

  • Clinical Trial Site

    Guwahati, Assam

  • Clinical Trial Site

    Hyderabad, Andhra Pradesh

  • Clinical Trial Site

    Jaipur, Rajasthan

  • Clinical Trial Site

    Lucknow, Uttar Pradesh, 226003

  • Clinical Trial Site

    Lucknow, Uttar Pradesh

  • Clinical Trial Site

    Madurai, Tamil Nadu

  • Clinical Trial Site

    Nagpur, Maharashtra

  • Clinical Trial Site

    Nashik, Maharashtra

  • Clinical Trial Site

    Pune, Maharashtra

  • Clinical Trial Site

    Secunderabad, Andhra Pradesh

Other trials in India

Latvia8 sites

  • Clinical Trial Site

    Daugavpils

  • Clinical Trial Site

    Riga, LV-1002

  • Clinical Trial Site

    Riga, LV-1005

  • Clinical Trial Site

    Riga, LV-1006

  • Clinical Trial Site

    Riga, LV-1010

  • Clinical Trial Site

    Valmiera

  • Clinical Trial Site

    Ventspils, LV-3601

  • Clinical Trial Site

    Ventspils

Other trials in Latvia

Canada6 sites

  • Clinical Trial Site

    London, Ontario

  • Clinical Trial Site

    Pointe-Claire, Quebec

  • Clinical Trial Site

    Saint John, New Brunswick

  • Clinical Trial Site

    Thornhill, Ontario

  • Clinical Trial Site

    Vancouver, British Columbia

  • Clinical Trial Site

    Vaughan, Ontario

Other trials in Canada

Hungary5 sites

  • Clinical Trial Site

    Békéscsaba

  • Clinical Trial Site

    Gyula

  • Clinical Trial Site

    Komárom

  • Clinical Trial Site

    Szekszárd

  • Clinical Trial Site

    Vác

Other trials in Hungary

Poland4 sites

  • Clinical Trial Site

    Bialystok

  • Clinical Trial Site

    Sopot

  • Clinical Trial Site

    Warsaw

  • Clinical Trial Site

    Wroclaw

Other trials in Poland

About this study

Official title: A Phase III, Open-Label Extension Trial of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia (IDA).

Being tested
Ferumoxytol
Keywords
Iron deficiency anemia, Feraheme, Ferumoxytol, IDA
Medical subject headings
Anemia, Iron-Deficiency

What participants receive

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

  • FerumoxytolDrug

    Also called Feraheme

    IV Ferumoxytol

Study groups in NCT01114217
Study groupRoleWhat they receive
FerumoxytolExperimentalParticipants received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139]. Participants enrolled in AMAG-FER-IDA-303, a 6-month Extension Study, were evaluated monthly and could receive treatment with ferumoxytol only if they met criteria defined as persistent or recurrent IDA, hemoglobin <11.0 grams per deciliter (g/dL) and transferrin saturation (TSAT) <20% at any evaluation visit, (except study termination visit). Participants who met criteria began a 5-week treatment period (TP) and received 2 doses of ferumoxytol 510 mg intravenously (IV). The first IV 510-mg dose was administered on TP Day 1 (Baseline); the second 2-8 (5±3) days after Dose 1. The first treatment course with ferumoxytol for participants who previously received placebo in AMAG-FER-IDA-301 was considered Course 1; Course 2 included participants who previously received ferumoxytol in AMAG-FER-IDA-301; subsequent treatment courses were serially numbered.
Receives: Drug: Ferumoxytol

What is being measured

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

  1. Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol

    Mean change in hemoglobin from TP Baseline (Day 1) to TP Week 5 following the first dose of ferumoxytol was calculated as: Hemoglobin Change = Hemoglobin (TP Week 5) - Hemoglobin (TP Baseline) TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing of Course 1.

    Change from Baseline used an imputed value of 0 for missing values at the post-baseline visit.

    Measured: TP Baseline (Day 1), TP Week 5

Secondary outcomes (6)

  1. Mean Change In Hemoglobin Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol After The First Course

    Mean change in hemoglobin from TP Baseline to TP Week 5 following each course of ferumoxytol after the first course was calculated for each participant as:

    Hemoglobin Change = Hemoglobin (TP Week 5) - Hemoglobin (TP Baseline) The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.

    Measured: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

  2. Percentage Of Participants With An Increase In Hemoglobin ≥2.0 g/dL At Any Time From TP Baseline To TP Week 5

    Proportion of participants with an increase in hemoglobin ≥2.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.

    Measured: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

  3. Percentage Of Participants Who Achieved A Hemoglobin Level ≥12.0 g/dL At Any Time From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol

    Proportion of participants who achieved a hemoglobin level ≥12.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.

    Measured: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

  4. Mean Change In TSAT Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol

    Mean change in TSAT from TP Baseline to TP Week 5 following each course of ferumoxytol.

    Measured: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

  5. Patient-reported Outcome Measure: Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol

    The FACIT-Fatigue questionnaire is a 13-item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue.

    Mean change in FACIT-Fatigue questionnaire from TP Baseline to TP Week 5 following each course of ferumoxytol was calculated as:

    FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline).

    TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing in each course.

    If the TP Week 5 FACIT-Fatigue Score value was missing, the change from TP Baseline was conservatively imputed as zero.

    Measured: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

  6. Time To Hemoglobin Increase Of ≥2.0 g/dL Or To A Hemoglobin Level Of ≥12.0 g/dL From Baseline

    Days to event was defined as the days from Baseline to the first time the participant met the criteria. Participants without any post-Baseline study visits were not included in this analysis.

    The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.

    Measured: TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3

Timeline

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

  1. First posted3 May 2010 (estimated)
  2. Study start27 Jul 2010
  3. Primary completion24 Sep 2012
  4. Study completion23 Apr 2013

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
634 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01114217
Sponsor's protocol ID
AMAG-FER-IDA-303
Status last verified
Mar 2022
First submitted
29 Apr 2010
Last updated
21 Apr 2022
Data monitoring committee
Yes

Publications

  • Vadhan-Raj S, Ford DC, Dahl NV, Bernard K, Li Z, Allen LF, Strauss WE. Safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy: Results of a phase III, open-label, 6-month extension study. Am J Hematol. 2016 Feb;91(2):E3-5. doi: 10.1002/ajh.24240. No abstract available.

    PubMed 26572233

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ferumoxytol in people with Iron Deficiency Anemia, run by AMAG Pharmaceuticals, Inc. at 140 sites in 6 countries.

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 2 inclusion and 2 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 21 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 140 sites in United States, India, Latvia, Canada, Hungary and 1 more country. 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?

Yes. Results are posted in the registry (first posted 11 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol (time frame: TP Baseline (Day 1), TP Week 5). 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 NCT01114217, which also lists 1 linked publication.

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 21 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