Status:
COMPLETED
A Crossover Safety Study of Ferumoxytol Versus Placebo
Lead Sponsor:
AMAG Pharmaceuticals, Inc.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 equ...
Eligibility Criteria
Inclusion
- Male or female patients \> 18 years.
- Have chronic kidney disease per K/DOQI guidelines.
- Baseline hemoglobin of \> 9.0 and \< 12.5 g/dl
Exclusion
- Women who are pregnant or lactating.
- Received another investigational drug or device within 30 days.
- Recent parenteral or oral iron therapy.
- Patients that have other causes of anemia.
- Major surgery within 30 days or anticipated or planned surgery during the study.
- Patients with active infections.
- Recent blood transfusions.
- Patients with known allergies to iron products.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00255450
Start Date
January 1 2005
End Date
August 1 2006
Last Update
November 11 2008
Active Locations (41)
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1
Mobile, Alabama, United States, 36608
2
Phoenix, Arizona, United States, 85012
3
Mountain View, California, United States, 94041
4
New Haven, Connecticut, United States, 06511