Trial Comparing the Safety of Two Different Intravenous Iron Formulations

Iron Deficiency Anemia Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00593619
• Other study ID #: HSREB13767
• Status: Suspended
• Phase: Phase 4
• First received: January 3, 2008
• Last updated: March 2, 2009
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: February 2009
• Source: London Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia
• Perioperative Blood Conservation

Intervention

Drug:
• Iron dextran
300mg in 250cc normal saline given over 2 hours
• Iron sucrose
300mg in 250cc normal saline given over 2 hours

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
London Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe adverse drug reactions (ADRs)		Immediate - during infusion	Yes
Secondary	Incidence of serious adverse drug reactions (ADRs)		Immediate and delayed - within 24hrs post infusion	Yes
Secondary	Incidence of anaphylactic/anaphylactoid ADRs		Immediate - during infusion	Yes
Secondary	Incidence of combined mild and moderate ADRs		Immediate - during infusion	Yes
Secondary	Incidence of delayed ADRs		delayed - within 24hrs post infusion	Yes
Secondary	Incidence of all-cause mortality		Immediate and delayed - within 24hrs post infusion	Yes
Secondary	Physician and nursing time required to manage ADRs		Immediate and delayed - within 24hrs post infusion	Yes
Secondary	Response in laboratory parameters		Within 1 month	No
Secondary	Cost effectiveness		Completion of study	No