Trial Comparing the Safety of Two Different Intravenous Iron Formulations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00593619
Recruitment Status : Suspended (Interim Analysis and review by Data Safety Monitoring Board)
First Posted : January 15, 2008
Last Update Posted : March 3, 2009
Information provided by:
London Health Sciences Centre

Brief Summary:
The purpose of this trial is to compare the safety profile using equal doses of intravenous iron dextran versus iron sucrose. The researchers hypothesize that significantly more patients receiving intravenous iron dextran (using the current intermediate molecular weight product) will have severe adverse outcomes than patients receiving iron sucrose in the adult non-hemodialysis outpatient population. Secondly, since these severe reactions may require additional nursing time and physician interventions that may negate any cost advantage of iron dextran, the researchers hypothesize that iron sucrose will be more cost-effective than iron dextran.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Perioperative Blood Conservation Drug: Iron dextran Drug: Iron sucrose Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Safety Comparison of Intravenous Iron Dextran Versus Iron Sucrose in an Adult Non-Hemodialysis Outpatient Population: A Pilot Study
Study Start Date : January 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Active Comparator: Iron Dextran Drug: Iron dextran
300mg in 250cc normal saline given over 2 hours
Other Name: Infufer, Sandoz Canada Incorporated, DIN 02221780

Active Comparator: Iron Sucrose Drug: Iron sucrose
300mg in 250cc normal saline given over 2 hours
Other Name: Venofer, Luitpold Pharmaceuticals Inc., DIN 02243716

Primary Outcome Measures :
  1. Incidence of severe adverse drug reactions (ADRs) [ Time Frame: Immediate - during infusion ]

Secondary Outcome Measures :
  1. Incidence of serious adverse drug reactions (ADRs) [ Time Frame: Immediate and delayed - within 24hrs post infusion ]
  2. Incidence of anaphylactic/anaphylactoid ADRs [ Time Frame: Immediate - during infusion ]
  3. Incidence of combined mild and moderate ADRs [ Time Frame: Immediate - during infusion ]
  4. Incidence of delayed ADRs [ Time Frame: delayed - within 24hrs post infusion ]
  5. Incidence of all-cause mortality [ Time Frame: Immediate and delayed - within 24hrs post infusion ]
  6. Physician and nursing time required to manage ADRs [ Time Frame: Immediate and delayed - within 24hrs post infusion ]
  7. Response in laboratory parameters [ Time Frame: Within 1 month ]
  8. Cost effectiveness [ Time Frame: Completion of study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 to 100
  • To be receiving intravenous iron

Exclusion Criteria:

  • Age < 18
  • Hemodialysis
  • Previous exposure to intravenous iron
  • Unable to provide written consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00593619

Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
London Health Sciences Centre
Principal Investigator: Ian H Chin-Yee, MD, FRCPC London Health Sciences Centre
Principal Investigator: Fiona E Ralley, MB ChB, FRCA London Health Sciences Centre
Study Director: Cyrus C Hsia, MD,FRCPC London Health Sciences Centre

Responsible Party: Ian H. Chin-Yee, Chair/Chief of Hematology, London Health Sciences Centre Identifier: NCT00593619     History of Changes
Other Study ID Numbers: HSREB13767
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: March 3, 2009
Last Verified: February 2009

Keywords provided by London Health Sciences Centre:
Intravenous Iron
Iron deficiency
Non hemodialysis population
Perioperative blood conservation

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric oxide, saccharated
Ferric Compounds
Iron-Dextran Complex
Trace Elements
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes