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Trial Comparing the Safety of Two Different Intravenous Iron Formulations

NCT00593619 · Status: SUSPENDED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2009-03-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Iron dextran

300mg in 250cc normal saline given over 2 hours

DRUG

Iron sucrose

300mg in 250cc normal saline given over 2 hours

Sponsors & Collaborators

  • London Health Sciences Centre

    lead OTHER

Principal Investigators

  • Ian H Chin-Yee, MD, FRCPC · London Health Sciences Centre

  • Fiona E Ralley, MB ChB, FRCA · London Health Sciences Centre

  • Cyrus C Hsia, MD,FRCPC · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00593619 on ClinicalTrials.gov