Safety Assessment of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)
NCT ID: NCT01151592
Last Updated: 2018-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Iron Sucrose
Iron Sucrose, 1000 mg cumulative dose to be administered per the US package insert.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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American Regent, Inc.
INDUSTRY
Responsible Party
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Locations
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Luitpold Pharmaceuticals, Inc.
Norristown, Pennsylvania, United States
Countries
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Other Identifiers
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1VEN10034
Identifier Type: -
Identifier Source: org_study_id
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