A Crossover Safety Study of Ferumoxytol Versus Placebo

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AMAG Pharmaceuticals, Inc.
• Treatments: Ferrosoferric Oxide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.