Safety Assessment of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Safety of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Drug: Iron Sucrose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iron Sucrose|Iron Sucrose, 1000 mg cumulative dose to be administered per the US package insert.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron deficiency anemia in Chronic Kidney Disease Patients