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

This study has been terminated.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01151592
First received: June 25, 2010
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

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).


Condition Intervention Phase
Iron Deficiency Anemia in Chronic Kidney Disease
Drug: Iron Sucrose
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Incidence and severity of adverse events, overall and related from Day of first iron sucrose administration through the end of the study. [ Time Frame: Day 0 through 30 days after the final administration of iron sucrose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: June 2010
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Iron Sucrose
    Iron Sucrose, 1000 mg cumulative dose to be administered per the US package insert.
    Other Name: Venofer
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01151592

Locations
United States, Pennsylvania
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
Luitpold Pharmaceuticals
  More Information

No publications provided

Responsible Party: Angelia Butcher, Luitpold Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01151592     History of Changes
Other Study ID Numbers: 1VEN10034
Study First Received: June 25, 2010
Last Updated: July 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Luitpold Pharmaceuticals:
Iron deficiency anemia in Chronic Kidney Disease Patients

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Deficiency Diseases
Anemia, Iron-Deficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Dextrans
Iron-Dextran Complex
Ferric oxide, saccharated
Ferric Compounds
Ferumoxytol
Iron
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
Blood Substitutes
Hematinics
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014