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

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

Summary

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.

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

Details

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

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.