Iron Deficiency Anemia
Conditions
Keywords
Iron deficiency anemia in Chronic Kidney Disease Patients
Brief summary
The objective of this study is to assess the safety and tolerability of Venofer in patients with chronic kidney disease who cannot tolerate Ferumoxytol (Feraheme) or intravenous iron containing a dextran (INFed or Dexferrum).
Detailed description
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.
Interventions
DRUGIron Sucrose
Iron Sucrose, 1000 mg cumulative dose to be administered per the US package insert.
Sponsors
American Regent, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events, overall and related from Day of first iron sucrose administration through the end of the study. | Day 0 through 30 days after the final administration of iron sucrose |
Countries
United States
Outcome results
None listed