A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia
1 other identifier
interventional
812
6 countries
182
Brief Summary
To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2010
182 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
April 29, 2010
CompletedFirst Posted
Study publicly available on registry
April 30, 2010
CompletedStudy Start
First participant enrolled
June 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2012
CompletedResults Posted
Study results publicly available
June 11, 2018
CompletedApril 21, 2022
March 1, 2022
1.7 years
April 29, 2010
March 26, 2018
March 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. 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. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase. Statistical analysis was performed for data up to Week 5 only.
Baseline (Day 1) through Week 5
Secondary Outcomes (5)
Mean Change In Hemoglobin From Baseline To Week 5
Baseline (Day 1), Week 5
Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5
Baseline (Day 1) through Week 5
Mean Change In TSAT From Baseline To Week 5
Baseline (Day 1), Week 5
Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5
Baseline (Day 1), Week 5
Time To Hemoglobin Increase Of ≥2.0 g/dL Or A Hemoglobin Value Of ≥12.0 g/dL From Baseline
From Baseline (Day 1) up to Week 5
Study Arms (2)
Ferumoxytol
EXPERIMENTALParticipants 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).
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Males and females ≥18 years of age
- Participants with IDA defined as having:
- Hemoglobin \<10.0 g/deciliter (dL)
- Transferrin saturation \<20%
- Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
- 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
You may not qualify if:
- History of allergy to IV iron
- Allergy to two or more classes of drugs
- Participants on dialysis or with an estimated glomerular filtration rate \<30 mL/minute/1.73 m\^2
- Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
- Hemoglobin ≤7.0 g/dL
- Serum ferritin \>600 nanograms/mL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (182)
Clinical Trial Site
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, 36106, 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, 85032, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, 85710, 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, 92653, 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, 90036, United States
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Los Angeles, California, 90057, 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, 92103, United States
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San Diego, California, 92123, 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, 33426, United States
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Boynton Beach, Florida, United States
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Clearwater, Florida, 33759, 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, 33126, United States
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Miami, Florida, 33143, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33175, 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, 33414, 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, 30308, United States
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Atlanta, Georgia, 30342, 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, 60611, 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, 60076, 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, 02451, United States
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Bay City, Michigan, 48706, 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, 10038, 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, 45202, 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, 43302, 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, 77030, United States
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Houston, Texas, 77074, 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, 78205, United States
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San Antonio, Texas, 78209, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78258, 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, 560002, 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, 302001, India
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Jaipur, Rajasthan, 302013, India
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Chennai, Tamil Nadu, 600096, 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, 226003, India
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Lucknow, Uttar Pradesh, India
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Daugavpils, Latvia
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Riga, LV-1002, Latvia
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Riga, LV-1005, Latvia
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Riga, LV-1006, Latvia
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Riga, LV-1010, Latvia
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Valmiera, LV-4201, Latvia
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Ventspils, LV-3601, Latvia
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Ventspils, Latvia
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Bialystok, Poland
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Sopot, Poland
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Warsaw, 02-341, Poland
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Warsaw, 03-580, Poland
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Wroclaw, Poland
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Zgierz, Poland
Related Publications (1)
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.
PMID: 23983177BACKGROUND
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2010
First Posted
April 30, 2010
Study Start
June 19, 2010
Primary Completion
February 27, 2012
Study Completion
October 22, 2012
Last Updated
April 21, 2022
Results First Posted
June 11, 2018
Record last verified: 2022-03