Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
750 participants
INTERVENTIONAL
2005-01-31
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
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ferumoxytol or placebo
Eligibility Criteria
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Inclusion Criteria
* Have chronic kidney disease per K/DOQI guidelines.
* Baseline hemoglobin of \> 9.0 and \< 12.5 g/dl
Exclusion Criteria
* Received another investigational drug or device within 30 days.
* Recent parenteral or oral iron therapy.
* Patients that have other causes of anemia.
* Major surgery within 30 days or anticipated or planned surgery during the study.
* Patients with active infections.
* Recent blood transfusions.
* Patients with known allergies to iron products.
18 Years
ALL
No
Sponsors
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AMAG Pharmaceuticals, Inc.
INDUSTRY
Locations
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Mobile, Alabama, United States
Phoenix, Arizona, United States
Mountain View, California, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Ocala, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Newnan, Georgia, United States
Peoria, Illinois, United States
Shreveport, Louisiana, United States
Shreveport, Louisiana, United States
Bethesda, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
Broken Bow, Nebraska, United States
Lebanon, New Hampshire, United States
Flushing, New York, United States
New York, New York, United States
New York, New York, United States
Orchard Park, New York, United States
Raleigh, North Carolina, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Erie, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Greenville, South Carolina, United States
Sumter, South Carolina, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Alexandria, Virginia, United States
Charlottesville, Virginia, United States
Chesapeake, Virginia, United States
Norfolk, Virginia, United States
Bluefield, West Virginia, United States
Appleton, Wisconsin, United States
Countries
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References
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Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK. Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005 Jul-Aug;25(4):400-10. doi: 10.1159/000087212. Epub 2005 Jul 28.
Singh A, Patel T, Hertel J, Bernardo M, Kausz A, Brenner L. Safety of ferumoxytol in patients with anemia and CKD. Am J Kidney Dis. 2008 Nov;52(5):907-15. doi: 10.1053/j.ajkd.2008.08.001. Epub 2008 Sep 27.
Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.
Related Links
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National Kidney Foundation
Other Identifiers
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62745-8
Identifier Type: -
Identifier Source: org_study_id