A Crossover Safety Study of Ferumoxytol Versus Placebo

Completed · Phase 3 · Has a placebo group

Conditions studied: Anemia

In brief

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

Key facts

Study ID

NCT00255450

Run by

AMAG Pharmaceuticals, Inc.

People needed

750

Starts

2005-01-01

Expected to finish

2006-08-01

Last updated by the study team

2008-11-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients > 18 years.
• Have chronic kidney disease per K/DOQI guidelines.
• Baseline hemoglobin of > 9.0 and < 12.5 g/dl

You may not qualify if…

• 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.

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Mountain View, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Ocala, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Newnan, Georgia, United States
• Study site — Peoria, Illinois, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Bethesda, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Broken Bow, Nebraska, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Flushing, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Orchard Park, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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