A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
July 18, 2023 updated by: AMAG Pharmaceuticals, Inc.
A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2014
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Sault Ste. Marie, Ontario, Canada
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Vaughan, Ontario, Canada
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Quebec
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Montréal, Quebec, Canada
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Budapest, Hungary
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Debrecen, Hungary
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Komárom, Hungary
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Szekszárd, Hungary
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Vác, Hungary
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Jelgava, Latvia
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Kraslava, Latvia
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Liepāja, Latvia
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Riga, Latvia, LV-1002
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Riga, Latvia, LV-1006
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Riga, Latvia, LV-1010
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Ventspils, Latvia
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Kaunas, Lithuania, LT-44320
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Kaunas, Lithuania, LT-48259
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Kaunas, Lithuania, LT-49449
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Klaipėda, Lithuania
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Utena, Lithuania
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Vilnius, Lithuania
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Šiauliai, Lithuania
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Białystok, Poland, 15-224
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Białystok, Poland, 15-732
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Warszawa, Poland
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Wrocław, Poland
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Ponce, Puerto Rico
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Alabama
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Huntsville, Alabama, United States
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Arizona
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Tucson, Arizona, United States
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Tucson, Arizona, United States, 85741
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California
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Anaheim, California, United States
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Chula Vista, California, United States
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Corona, California, United States
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Encino, California, United States
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Fountain Valley, California, United States
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Granada Hills, California, United States
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La Mesa, California, United States
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Orange, California, United States
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Oxnard, California, United States
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Riverside, California, United States
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San Diego, California, United States
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West Hollywood, California, United States
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Westminster, California, United States
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Connecticut
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Bristol, Connecticut, United States
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Norwalk, Connecticut, United States
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Florida
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Clearwater, Florida, United States
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Gainesville, Florida, United States
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Lauderdale Lakes, Florida, United States, 33313
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States, 33135
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Miami Lakes, Florida, United States
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North Miami, Florida, United States
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South Miami, Florida, United States
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West Palm Beach, Florida, United States
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Winter Haven, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Savannah, Georgia, United States
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Thomasville, Georgia, United States
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Illinois
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Elk Grove Village, Illinois, United States
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Evergreen Park, Illinois, United States
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Hazel Crest, Illinois, United States
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Skokie, Illinois, United States
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Skokie, Illinois, United States, 60202
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Kansas
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Wichita, Kansas, United States
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Kentucky
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Crestview Hills, Kentucky, United States
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Louisiana
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Maryland
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Massachusetts
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Waltham, Massachusetts, United States, 02451
- AMAG Pharmaceuticals, Inc.
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Michigan
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Bay City, Michigan, United States
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Flint, Michigan, United States
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Saginaw, Michigan, United States
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Saginaw, Michigan, United States, 48706
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Missouri
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Chesterfield, Missouri, United States
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Kansas City, Missouri, United States
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Kirksville, Missouri, United States
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Nevada
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Las Vegas, Nevada, United States
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New York
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East Setauket, New York, United States
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Flushing, New York, United States
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New York, New York, United States
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Rosedale, New York, United States
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North Carolina
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Asheville, North Carolina, United States, 28801
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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Jacksonville, North Carolina, United States
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Morehead City, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States, 45224
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Marion, Ohio, United States
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Oklahoma
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Norman, Oklahoma, United States
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Tulsa, Oklahoma, United States, 74104
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Tulsa, Oklahoma, United States
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Pennsylvania
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Jenkintown, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Scottdale, Pennsylvania, United States
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Smithfield, Pennsylvania, United States
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Upland, Pennsylvania, United States
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South Carolina
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Greenville, South Carolina, United States, 29615
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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South Dakota
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Rapid City, South Dakota, United States
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Tennessee
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Germantown, Tennessee, United States
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Kingsport, Tennessee, United States
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Memphis, Tennessee, United States
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Texas
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Austin, Texas, United States
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Fort Sam Houston, Texas, United States
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Houston, Texas, United States, 77030
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Houston, Texas, United States
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Houston, Texas, United States, 77081
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Longview, Texas, United States
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States
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San Antonio, Texas, United States, 78215
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San Antonio, Texas, United States, 78217
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Schertz, Texas, United States
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Utah
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Orem, Utah, United States
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Virginia
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Fredericksburg, Virginia, United States
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Norfolk, Virginia, United States
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Washington
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Seattle, Washington, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria include:
Participants with IDA and in whom IV iron treatment is indicated and defined as:
- Participants with documented hemoglobin <12.0 g per deciliter (dL) for females and <14.0 g/dL for males within 60 days of dosing And
- Participants with documented transferrin saturation (TSAT) ≤20% or Ferritin ≤100 nanograms (ng) per mL within 60 days of dosing
- Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate (as per oral iron history questionnaire)
- All participants (male and female) of childbearing potential who are sexually active who agree to routinely use adequate contraception from randomization throughout the duration of the study
Key Exclusion Criteria include:
- Known hypersensitivity reaction to any component of ferumoxytol or FCM
- History of allergy to an IV iron
- History of multiple drug allergies
- Participants with dialysis-dependent chronic kidney disease
- Hemoglobin ≤7.0 g/dL
- Female participants who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test or not willing to use effective contraceptive precautions during the study (including females of childbearing potential who are partners of male participants)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Ferumoxytol
Participants received an IV infusion of ferumoxytol 510 milligram (mg) diluted (17 milliliter [mL]) in 233 mL 0.9% sodium chloride injection, United States Pharmacopeia (USP) (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
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Other Names:
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Active Comparator: FCM
Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension
Time Frame: Day 1 (after first dosing) through Week 5
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All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). Hypotension is defined as a >30% drop in systolic blood pressure from baseline or decrease of >20 mmHg for systolic blood pressure. Statistical analysis was only performed on composite data. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
Day 1 (after first dosing) through Week 5
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death
Time Frame: Day 1 (after first dosing) through Week 5
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All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
Day 1 (after first dosing) through Week 5
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Mean Change In Hemoglobin From Baseline To Week 5
Time Frame: Baseline (Day 1), Week 5
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Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline).
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.
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Baseline (Day 1), Week 5
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Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5
Time Frame: Baseline (Day 1), Week 5
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Mean change in hemoglobin per g of iron administered from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline).
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.
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Baseline (Day 1), Week 5
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Adkinson NF, Strauss WE, Macdougall IC, Bernard KE, Auerbach M, Kaper RF, Chertow GM, Krop JS. Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: A randomized trial. Am J Hematol. 2018 May;93(5):683-690. doi: 10.1002/ajh.25060. Epub 2018 Feb 24.
- Adkinson NF, Strauss WE, Bernard K, Kaper RF, Macdougall IC, Krop JS. Comparative safety of intravenous Ferumoxytol versus Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia: rationale and study design of a randomized double-blind study with a focus on acute hypersensitivity reactions. J Blood Med. 2017 Sep 26;8:155-163. doi: 10.2147/JBM.S142236. eCollection 2017.
- Wolf M, Chertow GM, Macdougall IC, Kaper R, Krop J, Strauss W. Randomized trial of intravenous iron-induced hypophosphatemia. JCI Insight. 2018 Dec 6;3(23):e124486. doi: 10.1172/jci.insight.124486.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 29, 2016
Primary Completion (Actual)
January 16, 2017
Study Completion (Actual)
July 17, 2017
Study Registration Dates
First Submitted
February 8, 2016
First Submitted That Met QC Criteria
February 24, 2016
First Posted (Estimated)
March 1, 2016
Study Record Updates
Last Update Posted (Actual)
July 25, 2023
Last Update Submitted That Met QC Criteria
July 18, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMAG-FER-IDA-304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.