A Phase IV Trial of Repeated Doses of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Patients With Chronic Kidney Disease on Hemodialysis (FACT)
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The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.
Condition or disease
The Treatment of Iron Deficiency Anemia in Patients With Chronic Kidney Disease
Ferumoxytol for Anemia of CKD Trial (FACT): A Phase IV, Open-Label, Multicenter Trial, With MRI Substudy, of Repeated Doses of Ferumoxytol Compared With Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA) in Chronic Kidney Disease (CKD) Patients on Hemodialysis
Actual Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria include:
Males and females ≥18 years of age
Diagnosis of CKD
Subjects on dialysis must have been on dialysis for at least 3 months prior to screening
Female subjects of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study
Key Exclusion Criteria include:
History of allergy to either oral or IV iron
Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
Parenteral iron therapy within 30 days prior to screening or red blood cell (RBC)/whole blood transfusion within 14 days prior to screening or planned during the study