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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:
Information provided by:
London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00593619
First received: January 3, 2008
Last updated: March 2, 2009
Last verified: February 2009

January 3, 2008
March 2, 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 ] [ Designated as safety issue: Yes ]
Incidence of severe adverse drug reactions (ADRs) [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
  • Incidence of anaphylactic/anaphylactoid ADRs [ Time Frame: Immediate - during infusion ] [ Designated as safety issue: Yes ]
  • Incidence of combined mild and moderate ADRs [ Time Frame: Immediate - during infusion ] [ Designated as safety issue: Yes ]
  • Incidence of delayed ADRs [ Time Frame: delayed - within 24hrs post infusion ] [ Designated as safety issue: Yes ]
  • Incidence of all-cause mortality [ Time Frame: Immediate and delayed - within 24hrs post infusion ] [ Designated as safety issue: Yes ]
  • Physician and nursing time required to manage ADRs [ Time Frame: Immediate and delayed - within 24hrs post infusion ] [ Designated as safety issue: Yes ]
  • Response in laboratory parameters [ Time Frame: Within 1 month ] [ Designated as safety issue: No ]
  • Cost effectiveness [ Time Frame: Completion of study ] [ Designated as safety issue: No ]
  • Incidence of serious adverse drug reactions (ADRs) [ Time Frame: Immediate and delayed ] [ Designated as safety issue: Yes ]
  • Incidence of anaphylactic/anaphylactoid ADRs [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]
  • Incidence of combined mild and moderate ADRs [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]
  • Incidence of delayed ADRs [ Time Frame: delayed ] [ Designated as safety issue: Yes ]
  • Incidence of all-cause mortality [ Time Frame: Immediate and delayed ] [ Designated as safety issue: Yes ]
  • Physician and nursing time required to manage ADRs [ Time Frame: Immediate and delayed ] [ Designated as safety issue: Yes ]
  • Response in laboratory parameters [ Time Frame: Within 1 month ] [ Designated as safety issue: No ]
  • Cost effectiveness [ Time Frame: Completion of study ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00593619
HSREB13767
Yes
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