A Crossover Safety Study of Ferumoxytol Versus Placebo
A Double Blind, Placebo Controlled, Crossover Design, Multicenter Study of Intravenous Ferumoxytol Compared With Placebo
1 other identifier
interventional
750
1 country
41
Brief Summary
This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared to placebo in patients with chronic kidney disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2005
41 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
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 17, 2005
CompletedFirst Posted
Study publicly available on registry
November 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedNovember 11, 2008
October 1, 2007
November 17, 2005
November 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients \> 18 years.
- Have chronic kidney disease per K/DOQI guidelines.
- Baseline hemoglobin of \> 9.0 and \< 12.5 g/dl
You may not qualify if:
- Women who are pregnant or lactating.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Phoenix, Arizona, 85012, United States
Unknown Facility
Mountain View, California, 94041, United States
Unknown Facility
New Haven, Connecticut, 06511, United States
Unknown Facility
Washington D.C., District of Columbia, 20854, United States
Unknown Facility
Ocala, Florida, 34471, United States
Unknown Facility
Tampa, Florida, 33614, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Augusta, Georgia, 30901, United States
Unknown Facility
Newnan, Georgia, 30265, United States
Unknown Facility
Peoria, Illinois, 61603, United States
Unknown Facility
Shreveport, Louisiana, 71101, United States
Unknown Facility
Shreveport, Louisiana, 71103, United States
Unknown Facility
Bethesda, Maryland, 20814, United States
Unknown Facility
Boston, Massachusetts, 02135, United States
Unknown Facility
Detroit, Michigan, 48236, United States
Unknown Facility
St Louis, Missouri, 63136, United States
Unknown Facility
Broken Bow, Nebraska, 68822, United States
Unknown Facility
Lebanon, New Hampshire, 03756, United States
Unknown Facility
Flushing, New York, 11355, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
Orchard Park, New York, 14127, United States
Unknown Facility
Raleigh, North Carolina, 27609, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Portland, Oregon, 97213, United States
Unknown Facility
Erie, Pennsylvania, 16176, United States
Unknown Facility
Lancaster, Pennsylvania, 17604, United States
Unknown Facility
Greenville, South Carolina, 29605, United States
Unknown Facility
Sumter, South Carolina, 29150, United States
Unknown Facility
Chattanooga, Tennessee, 37404, United States
Unknown Facility
Knoxville, Tennessee, 37923, United States
Unknown Facility
Austin, Texas, 78758, United States
Unknown Facility
Houston, Texas, 77074, United States
Unknown Facility
San Antonio, Texas, 78212, United States
Unknown Facility
Alexandria, Virginia, 22304, United States
Unknown Facility
Charlottesville, Virginia, 22908, United States
Unknown Facility
Chesapeake, Virginia, 23320, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Unknown Facility
Bluefield, West Virginia, 24701, United States
Unknown Facility
Appleton, Wisconsin, 54911, United States
Related Publications (3)
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: 16088081BACKGROUNDSingh 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.
PMID: 18824288RESULTNatale 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.
PMID: 37651553DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 17, 2005
First Posted
November 21, 2005
Study Start
January 1, 2005
Study Completion
August 1, 2006
Last Updated
November 11, 2008
Record last verified: 2007-10