Clinical Trials Directory

Trials / Completed

CompletedNCT00255450

A Crossover Safety Study of Ferumoxytol Versus Placebo

A Double Blind, Placebo Controlled, Crossover Design, Multicenter Study of Intravenous Ferumoxytol Compared With Placebo

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
750 (planned)
Sponsor
AMAG Pharmaceuticals, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared to placebo in patients with chronic kidney disease.

Detailed description

This is a double-blind, placebo controlled, crossover design study of the safety of ferumoxytol compared to placebo. Patients are randomized to receive either one 510 mg dose of ferumoxytol or the equivalent volume of normal saline followed by the other test article given one week later.

Conditions

Interventions

TypeNameDescription
DRUGferumoxytol or placebo

Timeline

Start date
2005-01-01
Completion
2006-08-01
First posted
2005-11-21
Last updated
2008-11-11

Locations

41 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00255450. Inclusion in this directory is not an endorsement.