Back to resultsFerumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ferumoxytol or oral iron
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring anemia, iron
Eligibility Criteria
Inclusion Criteria: Male or female patients ≥18 years. Chronic hemodialysis. Stable supplemental EPO therapy. Baseline hemoglobin of ≤ 11.5 g/dl. Exclusion Criteria: Women who are pregnant or who are breast feeding. 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 surgery during the study. Patients with active infections. Recent blood transfusions. Patients with known allergies to iron products.
Sites / Locations
Outcomes
Primary Outcome Measures
The mean change in hemoglobin from baseline.
Secondary Outcome Measures
Change in iron indices.
Full Information
NCT ID
NCT00233597
First Posted
October 4, 2005
Last Updated
April 1, 2022
Sponsor
AMAG Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00233597
Brief Title
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients
Official Title
A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Hemodialysis Patients Who Are Receiving Supplemental EPO Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AMAG Pharmaceuticals, Inc.
4. Oversight
5. Study Description
Brief Summary
The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis.
Detailed Description
This study will evaluate the efficacy and safety of intravenous (IV) iron (ferumoxytol) as compared to oral iron in the treatment of anemia in hemodialysis patients receiving erythropoietin. Patients are randomized to receive either two doses of 510 mg of intravenous ferumoxytol in sequential dialysis sessions or 200 mg oral elemental iron daily for three weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
anemia, iron
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ferumoxytol or oral iron
Primary Outcome Measure Information:
Title
The mean change in hemoglobin from baseline.
Secondary Outcome Measure Information:
Title
Change in iron indices.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients ≥18 years.
Chronic hemodialysis.
Stable supplemental EPO therapy.
Baseline hemoglobin of ≤ 11.5 g/dl.
Exclusion Criteria:
Women who are pregnant or who are breast feeding.
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 surgery during the study.
Patients with active infections.
Recent blood transfusions.
Patients with known allergies to iron products.
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
City
Mountain View
State/Province
California
ZIP/Postal Code
94014
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60081
Country
United States
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
City
Columbus
State/Province
Mississippi
ZIP/Postal Code
39705
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11238
Country
United States
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
City
Springfield Gardens
State/Province
New York
ZIP/Postal Code
11413
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
City
Lewistown
State/Province
Pennsylvania
ZIP/Postal Code
17044
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75240
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54911
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16088081
Citation
Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK. Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005 Jul-Aug;25(4):400-10. doi: 10.1159/000087212. Epub 2005 Jul 28.
Results Reference
background
PubMed Identifier
19176796
Citation
Provenzano R, Schiller B, Rao M, Coyne D, Brenner L, Pereira BJ. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009 Feb;4(2):386-93. doi: 10.2215/CJN.02840608. Epub 2009 Jan 28.
Results Reference
result
Links:
URL
http://www.kidney.org/index.cfm
Description
National Kidney Foundation
Learn more about this trial
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients
We'll reach out to this number within 24 hrs