Trial Comparing the Safety of Two Different Intravenous Iron Formulations

March 2, 2009 updated by: London Health Sciences Centre

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Iron Sucrose
Drug: Iron sucrose
300mg in 250cc normal saline given over 2 hours
Other Names:
  • Venofer, Luitpold Pharmaceuticals Inc., DIN 02243716
Active Comparator: Iron Dextran
Drug: Iron dextran
300mg in 250cc normal saline given over 2 hours
Other Names:
  • Infufer, Sandoz Canada Incorporated, DIN 02221780

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of severe adverse drug reactions (ADRs)
Time Frame: Immediate - during infusion
Immediate - during infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious adverse drug reactions (ADRs)
Time Frame: Immediate and delayed - within 24hrs post infusion
Immediate and delayed - within 24hrs post infusion
Incidence of anaphylactic/anaphylactoid ADRs
Time Frame: Immediate - during infusion
Immediate - during infusion
Incidence of combined mild and moderate ADRs
Time Frame: Immediate - during infusion
Immediate - during infusion
Incidence of delayed ADRs
Time Frame: delayed - within 24hrs post infusion
delayed - within 24hrs post infusion
Incidence of all-cause mortality
Time Frame: Immediate and delayed - within 24hrs post infusion
Immediate and delayed - within 24hrs post infusion
Physician and nursing time required to manage ADRs
Time Frame: Immediate and delayed - within 24hrs post infusion
Immediate and delayed - within 24hrs post infusion
Response in laboratory parameters
Time Frame: Within 1 month
Within 1 month
Cost effectiveness
Time Frame: Completion of study
Completion of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Estimate)

March 3, 2009

Last Update Submitted That Met QC Criteria

March 2, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSREB13767

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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