Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients

Completed · Phase 3

Conditions studied: Anemia

In brief

The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients with chronic kidney disease who are not on dialysis.

Key facts

Study ID

NCT00255424

Run by

AMAG Pharmaceuticals, Inc.

People needed

304

Starts

2004-05-01

Expected to finish

2006-08-01

Last updated by the study team

2015-01-09

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.
• No change in EPO status during study.
• Baseline hemoglobin of ≤ 11.0 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 with active GI bleeding or acute bleeding within 4 weeks.
• Patients that have other causes of anemia.
• Major surgery within 30 days or anticipated or planned major surgery during the study.
• Patients whose EPO status changes while on study.
• Patients with active infections.
• Recent blood transfusions.
• Patients with any known allergies to iron products.

Where it is running

• Study site — Encino, California, United States
• Study site — Riverside, California, United States
• Study site — Tarzana, California, United States
• Study site — Ocala, Florida, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Flushing, New York, United States
• Study site — Orchard Park, New York, United States
• Study site — Columbus, Ohio, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Lancaster, Pennsylvania, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Knoxville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Fairfax, Virginia, United States
• Study site — Bluefield, West Virginia, United States
• Study site — Appleton, Wisconsin, United States

Full record on ClinicalTrials.gov

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