A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
NCT ID: NCT01114217
Last Updated: 2022-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
634 participants
INTERVENTIONAL
2010-07-27
2013-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ferumoxytol
Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 \[NCT01114139\]. Participants enrolled in AMAG-FER-IDA-303, a 6-month Extension Study, were evaluated monthly and could receive treatment with ferumoxytol only if they met criteria defined as persistent or recurrent IDA, hemoglobin \<11.0 grams per deciliter (g/dL) and transferrin saturation (TSAT) \<20% at any evaluation visit, (except study termination visit). Participants who met criteria began a 5-week treatment period (TP) and received 2 doses of ferumoxytol 510 mg intravenously (IV). The first IV 510-mg dose was administered on TP Day 1 (Baseline); the second 2-8 (5±3) days after Dose 1. The first treatment course with ferumoxytol for participants who previously received placebo in AMAG-FER-IDA-301 was considered Course 1; Course 2 included participants who previously received ferumoxytol in AMAG-FER-IDA-301; subsequent treatment courses were serially numbered.
Ferumoxytol
IV Ferumoxytol
Interventions
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Ferumoxytol
IV Ferumoxytol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Female participants of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study
Exclusion Criteria
2. Female participants who are pregnant, intend to become pregnant, are breastfeeding, or have a positive serum/urine pregnancy test
18 Years
ALL
No
Sponsors
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AMAG Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Montgomery, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Bakersfield, California, United States
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Buena Park, California, United States
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Colton, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Mission Hills, California, United States
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Orange, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Pueblo, Colorado, United States
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Bristol, Connecticut, United States
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Groton, Connecticut, United States
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Boynton Beach, Florida, United States
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Boynton Beach, Florida, United States
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Clearwater, Florida, United States
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Clearwater, Florida, United States
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Hialeah, Florida, United States
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Holiday, Florida, United States
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Inverness, Florida, United States
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Margate, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, 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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Naples, Florida, United States
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Vero Beach, Florida, United States
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West Palm Beach, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Dublin, Georgia, United States
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Sandy Springs, Georgia, United States
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Stockbridge, Georgia, United States
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Aurora, Illinois, United States
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Chicago, Illinois, United States
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Skokie, Illinois, United States
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Skokie, Illinois, United States
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Springfield, Illinois, United States
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Wichita, Kansas, United States
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New Orleans, Louisiana, United States
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Bethesda, Maryland, United States
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Hollywood, Maryland, United States
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Bay City, Michigan, United States
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Bay City, Michigan, United States
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Wyoming, Michigan, United States
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Kansas City, Missouri, United States
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Las Vegas, Nevada, United States
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Lawrenceville, New Jersey, United States
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Neptune City, New Jersey, United States
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Plainsboro, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canton, Ohio, United States
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Carlisle, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Marion, Ohio, United States
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Marion, Ohio, United States
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Mentor, Ohio, United States
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Middletown, Ohio, United States
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Zanesville, Ohio, United States
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Norman, Oklahoma, United States
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Jenkintown, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Columbia, South Carolina, United States
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Greer, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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North Charleston, South Carolina, United States
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Rapid City, South Dakota, United States
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Arlington, Texas, United States
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Dallas, 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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Laredo, 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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Orem, Utah, United States
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Chesapeake, Virginia, United States
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Norfolk, Virginia, United States
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Vancouver, British Columbia, Canada
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Saint John, New Brunswick, Canada
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London, Ontario, Canada
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Thornhill, Ontario, Canada
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Vaughan, Ontario, Canada
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Pointe-Claire, Quebec, Canada
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Békéscsaba, , Hungary
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Gyula, , Hungary
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Komárom, , Hungary
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Szekszárd, , Hungary
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Vác, , Hungary
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Hyderabad, Andhra Pradesh, India
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Secunderabad, Andhra Pradesh, India
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Guwahati, Assam, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Aurangabad, Maharashtra, India
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Nagpur, Maharashtra, India
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Nashik, Maharashtra, India
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Pune, Maharashtra, India
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Jaipur, Rajasthan, India
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Chennai, Tamil Nadu, India
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Madurai, Tamil Nadu, India
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Lucknow, Uttar Pradesh, India
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Lucknow, Uttar Pradesh, India
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Daugavpils, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Valmiera, , Latvia
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Ventspils, , Latvia
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Ventspils, , Latvia
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Bialystok, , Poland
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Sopot, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
Countries
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References
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Vadhan-Raj S, Ford DC, Dahl NV, Bernard K, Li Z, Allen LF, Strauss WE. Safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy: Results of a phase III, open-label, 6-month extension study. Am J Hematol. 2016 Feb;91(2):E3-5. doi: 10.1002/ajh.24240. No abstract available.
Other Identifiers
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AMAG-FER-IDA-303
Identifier Type: -
Identifier Source: org_study_id
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