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Anemia

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

Sponsored by AMAG Pharmaceuticals, Inc.

About this trial

Last updated 10 years ago

Study ID

62745-6

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 19 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.