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This study has been withdrawn prior to enrollment.
(Sponsor Decision)
Information provided by (Responsible Party):
Luitpold Pharmaceuticals Identifier:
First received: June 25, 2010
Last updated: July 7, 2015
Last verified: July 2015
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
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 ]

Enrollment: 0
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01151592

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

Responsible Party: Luitpold Pharmaceuticals Identifier: NCT01151592     History of Changes
Other Study ID Numbers: 1VEN10034 
Study First Received: June 25, 2010
Last Updated: July 7, 2015
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, Iron-Deficiency
Deficiency Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Renal Insufficiency
Urologic Diseases
Ferric Compounds
Ferric oxide, saccharated
Growth Substances
Hematologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements processed this record on April 27, 2016