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Iron Deficiency AnemiaPhase 3NCT01114139

A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia

A Phase 3 study testing Ferumoxytol in people with Iron Deficiency Anemia, run by AMAG Pharmaceuticals, Inc. at 182 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 efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for the 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?
Yes, some participants may receive a placebo
How many people
812 participants
Where
182 sitesin 6 countries
Study dates
19 Jun 2010to 22 Oct 2012
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

  • Males and females ≥18 years of age
  • Participants with IDA defined as having:
  • Hemoglobin <10.0 g/deciliter (dL)
  • Transferrin saturation <20%
  • Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
  • Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study

Who cannot join

  • History of allergy to IV iron
  • Allergy to two or more classes of drugs
  • Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute/1.73 m^2
  • Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
  • Hemoglobin ≤7.0 g/dL
  • Serum ferritin >600 nanograms/mL

Trial locations and contacts

182 sites in 6 countries.

182 sites in 6 countries

United States137 sites

  • Clinical Trial Site

    Akron, Ohio

  • Clinical Trial Site

    Albuquerque, New Mexico

  • Clinical Trial Site

    Alhambra, California

  • Clinical Trial Site

    Anaheim, California

  • Clinical Trial Site

    Arlington, Texas

  • Clinical Trial Site

    Atlanta, Georgia, 30308

  • Clinical Trial Site

    Atlanta, Georgia, 30342

  • Clinical Trial Site

    Atlanta, Georgia

  • 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

    Beavercreek, Ohio

  • Clinical Trial Site

    Bethesda, Maryland

  • Clinical Trial Site

    Birmingham, Alabama

  • Clinical Trial Site

    Bismarck, North Dakota

  • Clinical Trial Site

    Boynton Beach, Florida, 33426

  • Clinical Trial Site

    Boynton Beach, Florida

  • 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, 60611

  • Clinical Trial Site

    Chicago, Illinois

  • Clinical Trial Site

    Cincinnati, Ohio, 45202

  • Clinical Trial Site

    Cincinnati, Ohio

  • Clinical Trial Site

    Clearwater, Florida, 33759

  • Clinical Trial Site

    Clearwater, Florida

  • Clinical Trial Site

    Colton, California

  • Clinical Trial Site

    Columbia, South Carolina

  • Clinical Trial Site

    Columbus, Georgia

  • Clinical Trial Site

    Columbus, Ohio

  • Clinical Trial Site

    Dallas, Texas

  • Clinical Trial Site

    Dayton, Ohio

  • Clinical Trial Site

    Decatur, Georgia

  • Clinical Trial Site

    Dublin, Georgia

  • Clinical Trial Site

    East Providence, Rhode Island

  • Clinical Trial Site

    Evergreen Park, Illinois

  • Clinical Trial Site

    Fresno, California

  • Clinical Trial Site

    Glendale, California

  • Clinical Trial Site

    Goshen, New York

  • Clinical Trial Site

    Green Valley, Arizona

  • 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

    Indianapolis, Indiana

  • Clinical Trial Site

    Inverness, Florida

  • Clinical Trial Site

    Jenkintown, Pennsylvania

  • Clinical Trial Site

    Kansas City, Missouri

  • Clinical Trial Site

    Laguna Hills, California, 92653

  • Clinical Trial Site

    Laguna Hills, California

  • Clinical Trial Site

    Lakewood, California

  • 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, 33143

  • Clinical Trial Site

    Miami, Florida, 33144

  • Clinical Trial Site

    Miami, Florida, 33175

  • Clinical Trial Site

    Miami, Florida

  • 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

  • Clinical Trial Site

    Myrtle Beach, South Carolina

  • Clinical Trial Site

    Naples, Florida

  • Clinical Trial Site

    Nashville, Tennessee

  • Clinical Trial Site

    Neptune City, New Jersey

  • Clinical Trial Site

    New Orleans, Louisiana

  • Clinical Trial Site

    New York, New York, 10038

  • Clinical Trial Site

    New York, New York

  • Clinical Trial Site

    Newark, Delaware

  • Clinical Trial Site

    Norfolk, Virginia

  • Clinical Trial Site

    Norman, Oklahoma

  • Clinical Trial Site

    North Charleston, South Carolina

  • Clinical Trial Site

    Ocala, Florida

  • Clinical Trial Site

    Orange, California

  • Clinical Trial Site

    Orangeburg, South Carolina

  • Clinical Trial Site

    Orem, Utah

  • Clinical Trial Site

    Phoenix, Arizona, 85032

  • Clinical Trial Site

    Phoenix, Arizona

  • Clinical Trial Site

    Plainsboro, New Jersey

  • Clinical Trial Site

    Prince Frederick, Maryland

  • Clinical Trial Site

    Pueblo, Colorado

  • Clinical Trial Site

    Raleigh, North Carolina

  • Clinical Trial Site

    Rapid City, South Dakota

  • Clinical Trial Site

    Rome, Georgia

  • Clinical Trial Site

    Saginaw, Michigan

  • Clinical Trial Site

    San Antonio, Texas, 78205

  • Clinical Trial Site

    San Antonio, Texas, 78209

  • Clinical Trial Site

    San Antonio, Texas, 78229

  • Clinical Trial Site

    San Antonio, Texas, 78258

  • Clinical Trial Site

    San Antonio, Texas

  • Clinical Trial Site

    San Diego, California, 92103

  • Clinical Trial Site

    San Diego, California, 92123

  • Clinical Trial Site

    San Diego, California

  • Clinical Trial Site

    Sandy Springs, Georgia

  • Clinical Trial Site

    Savannah, Georgia

  • Clinical Trial Site

    Skokie, Illinois, 60076

  • Clinical Trial Site

    Skokie, Illinois

  • Clinical Trial Site

    Somerville, New Jersey

  • Clinical Trial Site

    Spring, Texas

  • Clinical Trial Site

    Springfield, Illinois

  • Clinical Trial Site

    Stockbridge, Georgia

  • Clinical Trial Site

    Tucson, Arizona, 85710

  • Clinical Trial Site

    Tucson, Arizona

  • Clinical Trial Site

    Vero Beach, Florida

  • Clinical Trial Site

    Voorhees Township, New Jersey

  • AMAG Pharmaceuticals, Inc.

    Waltham, Massachusetts, 02451

  • Clinical Trial Site

    Wellington, Florida, 33414

  • Clinical Trial Site

    Wellington, Florida

  • Clinical Trial Site

    West Palm Beach, Florida

  • Clinical Trial Site

    Wichita, Kansas

  • Clinical Trial Site

    Wilmington, North Carolina

  • Clinical Trial Site

    Winston-Salem, North Carolina

  • Clinical Trial Site

    Winter Park, Florida

  • Clinical Trial Site

    Wyoming, Michigan

  • Clinical Trial Site

    Zanesville, Ohio

  • Clinical Trial Site

    Zephyrhills, Florida

Other trials in United States

India19 sites

  • Clinical Trial Site

    Bangalore, Karnataka, 560002

  • Clinical Trial Site

    Bangalore, Karnataka

  • Clinical Trial Site

    Chennai, Tamil Nadu, 600096

  • Clinical Trial Site

    Chennai, Tamil Nadu

  • Clinical Trial Site

    Chhatrapati Sambhajinagar, Maharashtra

  • Clinical Trial Site

    Coimbatore, Tamil Nadu

  • Clinical Trial Site

    Guwahati, Assam

  • Clinical Trial Site

    Hyderabad, Andhra Pradesh

  • Clinical Trial Site

    Jaipur, Rajasthan, 302001

  • Clinical Trial Site

    Jaipur, Rajasthan, 302013

  • Clinical Trial Site

    Lucknow, Uttar Pradesh, 226003

  • Clinical Trial Site

    Lucknow, Uttar Pradesh

  • Clinical Trial Site

    Madurai, Tamil Nadu

  • Clinical Trial Site

    Mangalore, Karnataka

  • Clinical Trial Site

    Nagpur, Maharashtra

  • Clinical Trial Site

    Nashik, Maharashtra

  • Clinical Trial Site

    Pune, Maharashtra

  • Clinical Trial Site

    Secunderabad, Andhra Pradesh

  • Clinical Trial Site

    Visakhapatnam, Andhrapradesh

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, LV-4201

  • Clinical Trial Site

    Ventspils, LV-3601

  • Clinical Trial Site

    Ventspils

Other trials in Latvia

Canada7 sites

  • Clinical Trial Site

    London, Ontario

  • Clinical Trial Site

    Pointe-Claire, Quebec

  • Clinical Trial Site

    Saint John, New Brunswick

  • Clinical Trial Site

    Scarborough Village, Ontario

  • Clinical Trial Site

    Thornhill, Ontario

  • Clinical Trial Site

    Vancouver, British Columbia

  • Clinical Trial Site

    Vaughan, Ontario

Other trials in Canada

Poland6 sites

  • Clinical Trial Site

    Bialystok

  • Clinical Trial Site

    Sopot

  • Clinical Trial Site

    Warsaw, 02-341

  • Clinical Trial Site

    Warsaw, 03-580

  • Clinical Trial Site

    Wroclaw

  • Clinical Trial Site

    Zgierz

Other trials in Poland

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

About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia

To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).

Read the detailed description

This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical study evaluated the safety and efficacy of ferumoxytol compared with placebo for the treatment of IDA, specifically in adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. The effect of ferumoxytol on hemoglobin, iron parameters and patient reported outcomes (PROs) compared with placebo was evaluated. Investigators were blinded to key laboratory parameters that could potentially unblind the treatment arms of the study, eg, hemoglobin [Hgb], hematocrit [Hct], iron, ferritin, total iron binding capacity [TIBC], and transferrin saturation [TSAT], and neither the Investigators nor the subjects were aware of their treatment assignment, hemoglobin or other laboratory values.

Being tested
Ferumoxytol, Placebo
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

  • PlaceboOther

    IV Placebo

Study groups in NCT01114139
Study groupRoleWhat they receive
FerumoxytolExperimentalParticipants received a total of 2 doses of IV ferumoxytol 510 milligrams (mg) (17 milliliters [mL]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 grams (g).
Receives: Drug: Ferumoxytol
PlaceboPlacebo comparatorParticipants received a total of 2 doses of IV saline (17 mL). The first IV dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose.
Receives: Other: Placebo

What is being measured

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

  1. Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5

    Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on:

    Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5.

    Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase.

    Statistical analysis was performed for data up to Week 5 only.

    Measured: Baseline (Day 1) through Week 5

Secondary outcomes (5)

  1. Mean Change In Hemoglobin From Baseline To Week 5

    Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as:

    Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero. Participants without any post-Baseline hemoglobin values were treated as non-responders.

    Measured: Baseline (Day 1), Week 5

  2. Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5

    Participants who achieved a ≥12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on:

    Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants without any post-Baseline hemoglobin values were treated as non-responders.

    Measured: Baseline (Day 1) through Week 5

  3. Mean Change In TSAT From Baseline To Week 5

    Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) - TSAT (Baseline).

    TSAT, measured as a percentage, was part of the iron panel laboratory evaluations. Of the transferrin available to bind iron, this value indicates how much serum iron is bound. For example, a value of 20% means that 20% of iron-binding sites of transferrin are being occupied by iron. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero.

    Measured: Baseline (Day 1), Week 5

  4. Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5

    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 Score from Baseline to Week 5 was calculated for each participant as:

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

    Baseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero.

    Measured: Baseline (Day 1), Week 5

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

    The time to hemoglobin increase of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of ≥2.0 g/dL or to a hemoglobin level ≥12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included.

    Measured: From Baseline (Day 1) up to Week 5

Timeline

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

  1. First posted30 Apr 2010 (estimated)
  2. Study start19 Jun 2010
  3. Primary completion27 Feb 2012
  4. Study completion22 Oct 2012

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
Double blind
Who is masked
Participant, Investigator
Enrolment
812 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01114139
Sponsor's protocol ID
AMAG-FER-IDA-301
Status last verified
Mar 2022
First submitted
29 Apr 2010
Last updated
21 Apr 2022
Data monitoring committee
Yes

Publications

  • Vadhan-Raj S, Strauss W, Ford D, Bernard K, Boccia R, Li J, Allen LF. Efficacy and safety of IV ferumoxytol for adults with iron deficiency anemia previously unresponsive to or unable to tolerate oral iron. Am J Hematol. 2014 Jan;89(1):7-12. doi: 10.1002/ajh.23582. Epub 2013 Sep 30.

    PubMed 23983177

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 182 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 6 inclusion and 6 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 182 sites in United States, India, Latvia, Canada, Poland 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. Some participants in this study may receive a placebo. 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?

Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 (time frame: Baseline (Day 1) through 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 NCT01114139, 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.

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