Trial Comparing the Safety of Two Different Intravenous Iron Formulations

• Status: Suspended
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London Health Sciences Centre
• Treatments: Dextrans; Ferric Compounds; Ferric Oxide, Saccharated; Iron; Iron-Dextran Complex

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