Trial Comparing the Safety of Two Different Intravenous Iron Formulations

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.

Timeline

Start

2008-01

Primary completion

2009-12

Completion

2009-12

Outcome

Outcome not reported

Stopped: “Interim Analysis and review by Data Safety Monitoring Board”

Drugs

Indications