Safety Assessment of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)
Status: | Withdrawn |
---|---|
Conditions: | Iron Deficiency Anemia, Renal Impairment / Chronic Kidney Disease, Anemia |
Therapuetic Areas: | Hematology, Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/26/2018 |
Assessment of Safety of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)
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).
with chronic kidney disease who cannot tolerate Ferumoxytol (Feraheme) or intravenous iron
containing a dextran (INFed or Dexferrum).
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.
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.
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
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