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.
This study will evaluate the efficacy and safety of intravenous (IV) ferumoxytol as compared to oral iron in the treatment of anemia in non-dialysis dependent CKD patients. Patients are randomized to receive either two doses of 510 mg of ferumoxytol within one week or 200 mg oral elemental iron daily for three weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
304
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Tempe, Arizona, United States
Unnamed facility
New Haven, Connecticut, United States
The mean change in hemoglobin from baseline.
Change in iron indices.
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Unnamed facility
Augusta, Georgia, United States
Unnamed facility
Peoria, Illinois, United States
Unnamed facility
Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
Unnamed facility
Columbus, Mississippi, United States
Unnamed facility
Broken Bow, Nebraska, United States
...and 3 more locations