A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
1 other identifier
interventional
2,014
7 countries
127
Brief Summary
To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2016
127 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2016
CompletedStudy Start
First participant enrolled
February 29, 2016
CompletedFirst Posted
Study publicly available on registry
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2017
CompletedResults Posted
Study results publicly available
June 11, 2018
CompletedJuly 25, 2023
July 1, 2023
11 months
February 8, 2016
March 26, 2018
July 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension
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
Secondary Outcomes (3)
Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death
Day 1 (after first dosing) through Week 5
Mean Change In Hemoglobin From Baseline To Week 5
Baseline (Day 1), Week 5
Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5
Baseline (Day 1), Week 5
Study Arms (2)
Ferumoxytol
EXPERIMENTALParticipants 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.
FCM
ACTIVE COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (127)
Clinical Trial Site
Huntsville, Alabama, United States
Clinical Trial Site
Tucson, Arizona, 85741, United States
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Tucson, Arizona, United States
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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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Bristol, Connecticut, United States
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Norwalk, Connecticut, United States
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Clearwater, Florida, United States
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Gainesville, Florida, United States
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Lauderdale Lakes, Florida, 33313, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, 33135, United States
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Miami, Florida, United States
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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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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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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, 60202, United States
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Skokie, Illinois, United States
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Wichita, Kansas, United States
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Crestview Hills, Kentucky, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
AMAG Pharmaceuticals, Inc.
Waltham, Massachusetts, 02451, United States
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Bay City, Michigan, United States
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Flint, Michigan, United States
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Saginaw, Michigan, 48706, United States
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Saginaw, Michigan, United States
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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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Las Vegas, Nevada, United States
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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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Asheville, North Carolina, 28801, United States
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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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Cincinnati, Ohio, 45224, United States
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Cincinnati, Ohio, United States
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Marion, Ohio, United States
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Norman, Oklahoma, United States
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Tulsa, Oklahoma, 74104, United States
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Tulsa, Oklahoma, United States
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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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Greenville, South Carolina, 29615, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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Rapid City, South Dakota, United States
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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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Austin, Texas, United States
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Fort Sam Houston, Texas, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77081, United States
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Houston, Texas, United States
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Longview, Texas, United States
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San Antonio, Texas, 78215, United States
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San Antonio, Texas, 78217, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, United States
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Schertz, Texas, United States
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Orem, Utah, United States
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Fredericksburg, Virginia, United States
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Norfolk, Virginia, United States
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Seattle, Washington, United States
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Sault Ste. Marie, Ontario, Canada
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Vaughan, Ontario, Canada
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Montreal, 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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Krāslava, Latvia
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Liepāja, Latvia
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Riga, LV-1002, Latvia
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Riga, LV-1006, Latvia
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Riga, LV-1010, Latvia
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Ventspils, Latvia
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Kaunas, LT-44320, Lithuania
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Kaunas, LT-48259, Lithuania
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Kaunas, LT-49449, Lithuania
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Klaipėda, Lithuania
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Šiauliai, Lithuania
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Utena, Lithuania
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Vilnius, Lithuania
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Bialystok, 15-224, Poland
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Bialystok, 15-732, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Ponce, Puerto Rico
Related Publications (3)
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.
PMID: 29417614BACKGROUNDAdkinson 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.
PMID: 29033620BACKGROUNDWolf 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.
PMID: 30518682DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information
- Organization
- AMAG Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2016
First Posted
March 1, 2016
Study Start
February 29, 2016
Primary Completion
January 16, 2017
Study Completion
July 17, 2017
Last Updated
July 25, 2023
Results First Posted
June 11, 2018
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share