Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients
A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Hemodialysis Patients Who Are Receiving Supplemental EPO Therapy
1 other identifier
interventional
230
1 country
50
Brief Summary
The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2004
Typical duration for phase_3
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 4, 2005
CompletedFirst Posted
Study publicly available on registry
October 6, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedApril 4, 2022
April 1, 2022
October 4, 2005
April 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The mean change in hemoglobin from baseline.
Secondary Outcomes (1)
Change in iron indices.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients ≥18 years.
- Chronic hemodialysis.
- Stable supplemental EPO therapy.
- Baseline hemoglobin of ≤ 11.5 g/dl.
You may not qualify if:
- Women who are pregnant or who are breast feeding.
- Received another investigational drug or device within 30 days.
- Recent parenteral or oral iron therapy.
- Patients with active GI bleeding or acute bleeding within 4 weeks. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Unknown Facility
Phoenix, Arizona, 85012, United States
Unknown Facility
Tempe, Arizona, 85284, United States
Unknown Facility
Los Angeles, California, 90073, United States
Unknown Facility
Mountain View, California, 94014, United States
Unknown Facility
New Haven, Connecticut, 06511, United States
Unknown Facility
Hudson, Florida, 34667, United States
Unknown Facility
Tampa, Florida, 33614, United States
Unknown Facility
Augusta, Georgia, 30901, United States
Unknown Facility
Honolulu, Hawaii, 96817, United States
Unknown Facility
Gurnee, Illinois, 60081, United States
Unknown Facility
Hines, Illinois, 60141, United States
Unknown Facility
Baton Rouge, Louisiana, 70809, United States
Unknown Facility
Bethesda, Maryland, 20814, United States
Unknown Facility
Boston, Massachusetts, 02135, United States
Unknown Facility
Springfield, Massachusetts, 01107, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Detroit, Michigan, 48236, United States
Unknown Facility
Columbus, Mississippi, 39705, United States
Unknown Facility
Jackson, Mississippi, 39216, United States
Unknown Facility
Kansas City, Missouri, 64111, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Albuquerque, New Mexico, 87131, United States
Unknown Facility
Brooklyn, New York, 11203, United States
Unknown Facility
Brooklyn, New York, 11212, United States
Unknown Facility
Brooklyn, New York, 11238, United States
Unknown Facility
Flushing, New York, 11355, United States
Unknown Facility
Mineola, New York, 11501, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
New York, New York, 10128, United States
Unknown Facility
Orchard Park, New York, 14127, United States
Unknown Facility
Springfield Gardens, New York, 11413, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
Unknown Facility
Portland, Oregon, 97213, United States
Unknown Facility
Lewistown, Pennsylvania, 17044, United States
Unknown Facility
Greenville, South Carolina, 29605, United States
Unknown Facility
Sumter, South Carolina, 29150, United States
Unknown Facility
Knoxville, Tennessee, 37923, United States
Unknown Facility
Memphis, Tennessee, 38104, United States
Unknown Facility
Austin, Texas, 78758, United States
Unknown Facility
Corpus Christi, Texas, 78411, United States
Unknown Facility
Dallas, Texas, 75216, United States
Unknown Facility
Dallas, Texas, 75240, United States
Unknown Facility
Houston, Texas, 77099, United States
Unknown Facility
Alexandria, Virginia, 22304, United States
Unknown Facility
Chesapeake, Virginia, 23320, United States
Unknown Facility
Fairfax, Virginia, 22030, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Unknown Facility
Salem, Virginia, 24153, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
Appleton, Wisconsin, 54911, United States
Related Publications (2)
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.
PMID: 16088081BACKGROUNDProvenzano R, Schiller B, Rao M, Coyne D, Brenner L, Pereira BJ. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009 Feb;4(2):386-93. doi: 10.2215/CJN.02840608. Epub 2009 Jan 28.
PMID: 19176796RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 4, 2005
First Posted
October 6, 2005
Study Start
August 1, 2004
Study Completion
March 1, 2007
Last Updated
April 4, 2022
Record last verified: 2022-04