Overview

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.