A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia
NCT ID: NCT01114139
Last Updated: 2022-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
812 participants
INTERVENTIONAL
2010-06-19
2012-10-22
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
DOUBLE
Study Groups
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Ferumoxytol
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).
Ferumoxytol
IV Ferumoxytol
Placebo
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.
Placebo
IV Placebo
Interventions
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Ferumoxytol
IV Ferumoxytol
Placebo
IV Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants with IDA defined as having:
1. Hemoglobin \<10.0 g/deciliter (dL)
2. Transferrin saturation \<20%
3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
4. 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
Exclusion Criteria
2. Allergy to two or more classes of drugs
3. Participants on dialysis or with an estimated glomerular filtration rate \<30 mL/minute/1.73 m\^2
4. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
5. Hemoglobin ≤7.0 g/dL
6. Serum ferritin \>600 nanograms/mL
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
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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Green Valley, Arizona, 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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Alhambra, California, 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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Fresno, California, United States
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Glendale, California, United States
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Laguna Hills, California, United States
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Laguna Hills, California, United States
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Lakewood, 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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Newark, Delaware, 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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Ocala, Florida, United States
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Vero Beach, Florida, United States
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Wellington, Florida, United States
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Wellington, Florida, United States
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West Palm Beach, Florida, United States
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Winter Park, 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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Columbus, Georgia, United States
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Decatur, Georgia, United States
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Dublin, Georgia, United States
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Rome, Georgia, United States
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Sandy Springs, Georgia, United States
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Savannah, 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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Chicago, Illinois, United States
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Evergreen Park, 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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Indianapolis, Indiana, 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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Prince Frederick, Maryland, United States
AMAG Pharmaceuticals, Inc.
Waltham, Massachusetts, United States
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Bay City, Michigan, United States
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Bay City, Michigan, United States
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Saginaw, 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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Somerville, 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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Goshen, New York, United States
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New York, 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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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bismarck, North Dakota, United States
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Akron, Ohio, United States
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Beavercreek, Ohio, 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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Dayton, 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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East Providence, Rhode Island, 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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Orangeburg, South Carolina, United States
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Rapid City, South Dakota, United States
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Nashville, Tennessee, 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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San Antonio, Texas, United States
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Spring, 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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Scarborough Village, 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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Visakhapatnam, Andhrapradesh, 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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Mangalore, 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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Jaipur, Rajasthan, India
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Chennai, Tamil Nadu, India
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Chennai, Tamil Nadu, India
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Coimbatore, 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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Warsaw, , Poland
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Wroclaw, , Poland
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Zgierz, , Poland
Countries
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References
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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.
Other Identifiers
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AMAG-FER-IDA-301
Identifier Type: -
Identifier Source: org_study_id
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