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)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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 :
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
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