A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
NCT ID: NCT02694978
Last Updated: 2023-07-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2014 participants
INTERVENTIONAL
2016-02-29
2017-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Ferumoxytol
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.
FCM
Interventions
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Ferumoxytol
FCM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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AMAG Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Site
Huntsville, Alabama, United States
Clinical Trial Site
Tucson, Arizona, 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, United States
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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
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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, 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, 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, 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, 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, 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, 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, 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, United States
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Houston, Texas, 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, United States
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San Antonio, Texas, United States
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San Antonio, Texas, 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, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Ventspils, , Latvia
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Kaunas, , Lithuania
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Kaunas, , Lithuania
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Kaunas, , 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, , Poland
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Bialystok, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Ponce, , Puerto Rico
Countries
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References
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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.
Other Identifiers
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AMAG-FER-IDA-304
Identifier Type: -
Identifier Source: org_study_id
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