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NCT01151592 Clinical Trial

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

Iron Deficiency Anemia Clinical Trial

— ASSURED  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01151592
Other study ID # 1VEN10034
Secondary ID
Status Withdrawn
Phase Phase 4
First received June 25, 2010
Last updated January 22, 2018

Study information
Verified date January 2018
Source Luitpold Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Iron Sucrose
Iron Sucrose, 1000 mg cumulative dose to be administered per the US package insert.

Locations
Country Name City State
United States Luitpold Pharmaceuticals, Inc. Norristown Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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