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
  Purpose

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 Intervention Phase
Iron Deficiency Anemia
Perioperative Blood Conservation
Drug: Iron dextran
Drug: Iron sucrose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:
  • Incidence of severe adverse drug reactions (ADRs) [ Time Frame: Immediate - during infusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  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 ClinicalTrials.gov identifier: NCT00593619

Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
London Health Sciences Centre
Investigators
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
  More Information

No publications provided

Responsible Party: Ian H. Chin-Yee, Chair/Chief of Hematology, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00593619     History of Changes
Other Study ID Numbers: HSREB13767
Study First Received: January 3, 2008
Last Updated: March 2, 2009
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Anemia
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Dextrans
Iron-Dextran Complex
Ferric oxide, saccharated
Ferric Compounds
Iron
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
Blood Substitutes
Hematinics
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014