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Trial Comparing the Safety of Two Different Intravenous Iron Formulations

This study has suspended participant recruitment.
(Interim Analysis and review by Data Safety Monitoring Board)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593619
First Posted: January 15, 2008
Last Update Posted: March 3, 2009
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.
Information provided by:
London Health Sciences Centre
January 3, 2008
January 15, 2008
March 3, 2009
January 2008
December 2009   (Final data collection date for primary outcome measure)
Incidence of severe adverse drug reactions (ADRs) [ Time Frame: Immediate - during infusion ]
Incidence of severe adverse drug reactions (ADRs) [ Time Frame: Immediate ]
Complete list of historical versions of study NCT00593619 on ClinicalTrials.gov Archive Site
  • Incidence of serious adverse drug reactions (ADRs) [ Time Frame: Immediate and delayed - within 24hrs post infusion ]
  • Incidence of anaphylactic/anaphylactoid ADRs [ Time Frame: Immediate - during infusion ]
  • Incidence of combined mild and moderate ADRs [ Time Frame: Immediate - during infusion ]
  • Incidence of delayed ADRs [ Time Frame: delayed - within 24hrs post infusion ]
  • Incidence of all-cause mortality [ Time Frame: Immediate and delayed - within 24hrs post infusion ]
  • Physician and nursing time required to manage ADRs [ Time Frame: Immediate and delayed - within 24hrs post infusion ]
  • Response in laboratory parameters [ Time Frame: Within 1 month ]
  • Cost effectiveness [ Time Frame: Completion of study ]
  • Incidence of serious adverse drug reactions (ADRs) [ Time Frame: Immediate and delayed ]
  • Incidence of anaphylactic/anaphylactoid ADRs [ Time Frame: Immediate ]
  • Incidence of combined mild and moderate ADRs [ Time Frame: Immediate ]
  • Incidence of delayed ADRs [ Time Frame: delayed ]
  • Incidence of all-cause mortality [ Time Frame: Immediate and delayed ]
  • Physician and nursing time required to manage ADRs [ Time Frame: Immediate and delayed ]
  • Response in laboratory parameters [ Time Frame: Within 1 month ]
  • Cost effectiveness [ Time Frame: Completion of study ]
Not Provided
Not Provided
 
Trial Comparing the Safety of Two Different Intravenous Iron Formulations
A Randomized Double-Blind Safety Comparison of Intravenous Iron Dextran Versus Iron Sucrose in an Adult Non-Hemodialysis Outpatient Population: A Pilot Study
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
  • Iron Deficiency Anemia
  • Perioperative Blood Conservation
  • Drug: Iron dextran
    300mg in 250cc normal saline given over 2 hours
    Other Name: Infufer, Sandoz Canada Incorporated, DIN 02221780
  • Drug: Iron sucrose
    300mg in 250cc normal saline given over 2 hours
    Other Name: Venofer, Luitpold Pharmaceuticals Inc., DIN 02243716
  • Active Comparator: Iron Dextran
    Intervention: Drug: Iron dextran
  • Active Comparator: Iron Sucrose
    Intervention: Drug: Iron sucrose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
200
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00593619
HSREB13767
Yes
Not Provided
Not Provided
Ian H. Chin-Yee, Chair/Chief of Hematology, London Health Sciences Centre
London Health Sciences Centre
Not Provided
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
London Health Sciences Centre
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP