Safety Assessment of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)
Withdrawn before enrolling · Phase 4
Conditions studied: Iron Deficiency Anemia
In brief
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).
Key facts
- Study ID
- NCT01151592
- Run by
- American Regent, Inc.
- People needed
- 0
- Last updated by the study team
- 2018-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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
Where it is running
- Luitpold Pharmaceuticals, Inc. — Norristown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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