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.

Country

City, postcode or hospital

182 sites in 6 countries

United States137 sites

Clinical Trial Site
Akron, Ohio
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Albuquerque, New Mexico
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Alhambra, California
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Anaheim, California
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Arlington, Texas
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Atlanta, Georgia, 30308
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Atlanta, Georgia, 30342
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Atlanta, Georgia
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Aurora, Illinois
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Bakersfield, California
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Bay City, Michigan, 48706
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Bay City, Michigan
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Beavercreek, Ohio
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Bethesda, Maryland
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Birmingham, Alabama
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Bismarck, North Dakota
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Boynton Beach, Florida, 33426
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Boynton Beach, Florida
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Bristol, Connecticut
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Brooklyn, New York
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Buena Park, California
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Canton, Ohio
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Carlisle, Ohio
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Chesapeake, Virginia
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Chicago, Illinois, 60611
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Chicago, Illinois
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Cincinnati, Ohio, 45202
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Cincinnati, Ohio
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Clearwater, Florida, 33759
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Clearwater, Florida
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Colton, California
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Columbia, South Carolina
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Columbus, Georgia
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Columbus, Ohio
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Dallas, Texas
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Dayton, Ohio
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Decatur, Georgia
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Dublin, Georgia
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East Providence, Rhode Island
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Evergreen Park, Illinois
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Fresno, California
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Glendale, California
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Goshen, New York
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Green Valley, Arizona
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Greer, South Carolina
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Groton, Connecticut
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Hialeah, Florida
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Holiday, Florida
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Hollywood, Maryland
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Houston, Texas, 77030
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Houston, Texas, 77074
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Houston, Texas
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Indianapolis, Indiana
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Inverness, Florida
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Jenkintown, Pennsylvania
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Kansas City, Missouri
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Laguna Hills, California, 92653
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Laguna Hills, California
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Lakewood, California
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Laredo, Texas
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Las Vegas, Nevada
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Lawrenceville, New Jersey
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Levittown, Pennsylvania
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Longview, Texas
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Los Angeles, California, 90036
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Los Angeles, California, 90057
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Los Angeles, California
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Margate, Florida
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Marion, Ohio, 43302
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Marion, Ohio
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Mentor, Ohio
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Miami, Florida, 33126
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Miami, Florida, 33143
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Miami, Florida, 33144
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Miami, Florida, 33175
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Miami, Florida
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Miami Lakes, Florida
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Middletown, Ohio
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Mission Hills, California
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Mobile, Alabama
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Montgomery, Alabama, 36106
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Montgomery, Alabama
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Myrtle Beach, South Carolina
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Naples, Florida
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Nashville, Tennessee
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Neptune City, New Jersey
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New Orleans, Louisiana
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New York, New York, 10038
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New York, New York
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Newark, Delaware
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Norfolk, Virginia
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Norman, Oklahoma
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North Charleston, South Carolina
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Ocala, Florida
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Orange, California
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Orangeburg, South Carolina
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Orem, Utah
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Phoenix, Arizona, 85032
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Phoenix, Arizona
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Plainsboro, New Jersey
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Prince Frederick, Maryland
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Pueblo, Colorado
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Raleigh, North Carolina
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Rapid City, South Dakota
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Rome, Georgia
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Saginaw, Michigan
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San Antonio, Texas, 78205
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San Antonio, Texas, 78209
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San Antonio, Texas, 78229
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San Antonio, Texas, 78258
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San Antonio, Texas
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San Diego, California, 92103
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San Diego, California, 92123
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San Diego, California
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Sandy Springs, Georgia
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Savannah, Georgia
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Skokie, Illinois, 60076
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Skokie, Illinois
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Somerville, New Jersey
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Spring, Texas
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Springfield, Illinois
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Stockbridge, Georgia
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Tucson, Arizona, 85710
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Tucson, Arizona
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Vero Beach, Florida
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Voorhees Township, New Jersey
AMAG Pharmaceuticals, Inc.
Waltham, Massachusetts, 02451
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Wellington, Florida, 33414
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Wellington, Florida
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West Palm Beach, Florida
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Wichita, Kansas
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Wilmington, North Carolina
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Winston-Salem, North Carolina
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Winter Park, Florida
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Wyoming, Michigan
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Zanesville, Ohio
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Zephyrhills, Florida

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India19 sites

Clinical Trial Site
Bangalore, Karnataka, 560002
Clinical Trial Site
Bangalore, Karnataka
Clinical Trial Site
Chennai, Tamil Nadu, 600096
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Chennai, Tamil Nadu
Clinical Trial Site
Chhatrapati Sambhajinagar, Maharashtra
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Coimbatore, Tamil Nadu
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Guwahati, Assam
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Hyderabad, Andhra Pradesh
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Jaipur, Rajasthan, 302001
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Jaipur, Rajasthan, 302013
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Lucknow, Uttar Pradesh, 226003
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Lucknow, Uttar Pradesh
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Madurai, Tamil Nadu
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Mangalore, Karnataka
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Nagpur, Maharashtra
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Nashik, Maharashtra
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Pune, Maharashtra
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Secunderabad, Andhra Pradesh
Clinical Trial Site
Visakhapatnam, Andhrapradesh

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Clinical Trial Site
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Ventspils, LV-3601
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Thornhill, Ontario
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Vancouver, British Columbia
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Vaughan, Ontario

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Poland6 sites

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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.

Conditions: Iron Deficiency Anemia
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 group	Role	What they receive
Ferumoxytol	Experimental	Participants 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
Placebo	Placebo comparator	Participants 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.

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)

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
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
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
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
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.

19 Jun 201022 Oct 2012

First posted30 Apr 2010 (estimated)
Study start19 Jun 2010
Primary completion27 Feb 2012
Study completion22 Oct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Results posted: Yes, on ClinicalTrials.gov
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention

All Iron Deficiency Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia
ClinicalTrials.gov ID: NCT01114139
Acronym / sponsor ID: AMAG-FER-IDA-301
Conditions: Iron Deficiency Anemia
Keywords: Iron deficiency anemia, Feraheme, ferumoxytol, IDA
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 812 participants (actual)
Lead sponsor: AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 19 Jun 2010 (actual)
Primary completion: 27 Feb 2012 (actual)
Study completion: 22 Oct 2012 (actual)
First posted: 30 Apr 2010 (estimated)
Results: Posted 11 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Ferumoxytol	Experimental	Drug: FerumoxytolParticipants 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).
Placebo	Placebo comparator	Other: PlaceboParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Males and females ≥18 years of age
Participants with IDA defined as having:
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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FerumoxytolAlso: FerahemeIV Ferumoxytol	Drug	Ferumoxytol
PlaceboIV Placebo	Other	Placebo

Primary outcome

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
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.

5 secondary outcomes

Mean Change In Hemoglobin From Baseline To Week 5
Time frame: Baseline (Day 1), Week 5
Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5
Time frame: Baseline (Day 1) through Week 5
Mean Change In TSAT From Baseline To Week 5
Time frame: Baseline (Day 1), Week 5
Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5
Time frame: Baseline (Day 1), Week 5
Time To Hemoglobin Increase Of ≥2.0 g/dL Or A Hemoglobin Value Of ≥12.0 g/dL From Baseline
Time frame: From Baseline (Day 1) up to Week 5

Results and safety

Results posted to the registry on 11 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ferumoxytol	609	569
Placebo	203	187

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Ferumoxytol n = 608	Placebo n = 200
Up to Week 2	252	5
Up to Week 3	386	7
Up to Week 4	460	8
Up to Week 5	493	11

Ferumoxytol vs Placebo: Treatment Difference: 75.59 (95% CI 71.15 to 80.02), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: Intent-To-Treat (ITT) Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ferumoxytol	16 of 608 (2.6%)	198 of 608 (32.6%)	Not reported
Placebo	6 of 200 (3%)	56 of 200 (28%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23983177Vadhan-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.

Related trials for Iron Deficiency Anemia

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
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RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
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Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

182 sites in 6 countries: see every site and its status.

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.