Safety Assessment of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
American Regent, Inc.
This is a Phase IV, multi-center, open label study that assesses the safety and tolerability of Iron Sucrose (Venofer) in subjects with CKD who require intravenous iron for the treatment of iron deficiency anemia (IDA) but cannot tolerate Ferumoxytol or Iron Dextran.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subjects \> or = to 18 years of age
Determined by treating physician to have chronic kidney disease and require a course of intravenous iron
Subject did not tolerate an intravenous iron containing a dextran or Ferumoxytol within the last year
Subjects with hemodialysis-dependent or peritoneal dialysis chronic kidney disease should be receiving an erythropoiesis stimulating agent (ESA) as per the iron sucrose package insert
You may not be if
Known history of hypersensitivity or significant intolerance to iron sucrose
Evidence of iron overload
Hemochromatosis or other iron storage disorders
Received an investigational drug within 30 days of screening
Any other laboratory abnormality, medical condition or psychiatric disorder which would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
Pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception
