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

Sponsor

AMAG Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00255437

Collaborator

(none)

304

Enrollment

Locations

Duration (Months)

23.4

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anemia	Drug: ferumoxytol or oral iron	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Chronic Kidney Disease Patients Not on Dialysis

Study Start Date :

Jun 1, 2004

Actual Study Completion Date :

Nov 1, 2006

Outcome Measures

Primary Outcome Measures

The mean change in hemoglobin from baseline. []

Secondary Outcome Measures

Change in iron indices. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Phoenix	Arizona	United States	85012
2	Tempe	Arizona	United States	85284
3	New Haven	Connecticut	United States	06511
4	Augusta	Georgia	United States	30901
5	Peoria	Illinois	United States	61603
6	Bethesda	Maryland	United States	20814
7	Boston	Massachusetts	United States	02115
8	Detroit	Michigan	United States	48202
9	Columbus	Mississippi	United States	39705
10	Broken Bow	Nebraska	United States	68822
11	Greenville	South Carolina	United States	29605
12	Charlottesville	Virginia	United States	22908
13	Norfolk	Virginia	United States	23507