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

American Regent

Status and phase: Withdrawn; Phase 4

Conditions: Iron Deficiency Anemia

Treatments: Drug: Iron Sucrose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01151592

1VEN10034

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)