Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients
NCT ID: NCT00255424
Last Updated: 2015-01-09
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
304 participants
INTERVENTIONAL
2004-05-31
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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ferumoxytol or oral iron
Eligibility Criteria
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Inclusion Criteria
* Have chronic kidney disease per K/DOQI guidelines.
* No change in EPO status during study.
* Baseline hemoglobin of ≤ 11.0 g/dl.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AMAG Pharmaceuticals, Inc.
INDUSTRY
Locations
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Encino, California, United States
Riverside, California, United States
Tarzana, California, United States
Ocala, Florida, United States
Shreveport, Louisiana, United States
Shreveport, Louisiana, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
Flushing, New York, United States
Orchard Park, New York, United States
Columbus, Ohio, United States
Hershey, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Houston, Texas, United States
Fairfax, 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.
Spinowitz 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.
Fishbane 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.
Related Links
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National Kidney Foundation
Other Identifiers
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62745-6
Identifier Type: -
Identifier Source: org_study_id
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