Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients
A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Chronic Kidney Disease Patients Not on Dialysis
1 other identifier
interventional
304
1 country
19
Brief Summary
The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients with chronic kidney disease who are not on dialysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2004
19 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
May 1, 2004
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
CompletedJanuary 9, 2015
October 1, 2008
November 17, 2005
January 7, 2015
Conditions
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.
- Have chronic kidney disease per K/DOQI guidelines.
- No change in EPO status during study.
- Baseline hemoglobin of ≤ 11.0 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 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 major surgery during the study.
- Patients whose EPO status changes while on study.
- Patients with active infections.
- Recent blood transfusions.
- Patients with any known allergies to iron products.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Encino, California, 91356, United States
Unknown Facility
Riverside, California, 92501, United States
Unknown Facility
Tarzana, California, 91356, United States
Unknown Facility
Ocala, Florida, 34471, United States
Unknown Facility
Shreveport, Louisiana, 71101, United States
Unknown Facility
Shreveport, Louisiana, 71103, United States
Unknown Facility
Springfield, Massachusetts, 01107, United States
Unknown Facility
Detroit, Michigan, 48236, United States
Unknown Facility
Flushing, New York, 11355, United States
Unknown Facility
Orchard Park, New York, 14127, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Hershey, Pennsylvania, 17033, United States
Unknown Facility
Lancaster, Pennsylvania, 17604, United States
Unknown Facility
Chattanooga, Tennessee, 37404, United States
Unknown Facility
Knoxville, Tennessee, 37923, United States
Unknown Facility
Houston, Texas, 77074, United States
Unknown Facility
Fairfax, Virginia, 22030, 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: 16088081BACKGROUNDSpinowitz BS, Kausz AT, Baptista J, Noble SD, Sothinathan R, Bernardo MV, Brenner L, Pereira BJ. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol. 2008 Aug;19(8):1599-605. doi: 10.1681/ASN.2007101156. Epub 2008 Jun 4.
PMID: 18525001RESULTFishbane S, Bolton WK, Winkelmayer WC, Strauss W, Li Z, Pereira BJ. Factors affecting response and tolerability to ferumoxytol in nondialysis chronic kidney disease patients. Clin Nephrol. 2012 Sep;78(3):181-8. doi: 10.5414/cn107397.
PMID: 22874106RESULT
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
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 17, 2005
First Posted
November 21, 2005
Study Start
May 1, 2004
Study Completion
August 1, 2006
Last Updated
January 9, 2015
Record last verified: 2008-10