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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-11-30

Brief Summary

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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.

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Detailed Description

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This study will evaluate the efficacy and safety of intravenous (IV) ferumoxytol as compared to oral iron in the treatment of anemia in non-dialysis dependent CKD patients. Patients are randomized to receive either two doses of 510 mg of ferumoxytol within one week or 200 mg oral elemental iron daily for three weeks.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ferumoxytol or oral iron

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No