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

NCT00255424

Collaborator

(none)

304

Enrollment

Locations

Duration (Months)

Patients Per Site

0.6

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 :

May 1, 2004

Actual Study Completion Date :

Aug 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	Encino	California	United States	91356
2	Riverside	California	United States	92501
3	Tarzana	California	United States	91356
4	Ocala	Florida	United States	34471
5	Shreveport	Louisiana	United States	71101
6	Shreveport	Louisiana	United States	71103
7	Springfield	Massachusetts	United States	01107
8	Detroit	Michigan	United States	48236
9	Flushing	New York	United States	11355
10	Orchard Park	New York	United States	14127
11	Columbus	Ohio	United States	43210
12	Hershey	Pennsylvania	United States	17033
13	Lancaster	Pennsylvania	United States	17604
14	Chattanooga	Tennessee	United States	37404
15	Knoxville	Tennessee	United States	37923
16	Houston	Texas	United States	77074
17	Fairfax	Virginia	United States	22030
18	Bluefield	West Virginia	United States	24701
19	Appleton	Wisconsin	United States	54911