Back to resultsA Crossover Safety Study of Ferumoxytol Versus Placebo
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ferumoxytol or placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring anemia
Eligibility Criteria
Inclusion Criteria: Male or female patients > 18 years. Have chronic kidney disease per K/DOQI guidelines. Baseline hemoglobin of > 9.0 and < 12.5 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 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
Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation.
Secondary Outcome Measures
Full Information
NCT ID
NCT00255450
First Posted
November 17, 2005
Last Updated
November 10, 2008
Sponsor
AMAG Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00255450
Brief Title
A Crossover Safety Study of Ferumoxytol Versus Placebo
Official Title
A Double Blind, Placebo Controlled, Crossover Design, Multicenter Study of Intravenous Ferumoxytol Compared With Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AMAG Pharmaceuticals, Inc.
4. Oversight
5. Study Description
Brief Summary
This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared to placebo in patients with chronic kidney disease.
Detailed Description
This is a double-blind, placebo controlled, crossover design study of the safety of ferumoxytol compared to placebo. Patients are randomized to receive either one 510 mg dose of ferumoxytol or the equivalent volume of normal saline followed by the other test article given one week later.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
750 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ferumoxytol or placebo
Primary Outcome Measure Information:
Title
Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation.
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.
Have chronic kidney disease per K/DOQI guidelines.
Baseline hemoglobin of > 9.0 and < 12.5 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 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
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
City
Mountain View
State/Province
California
ZIP/Postal Code
94041
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20854
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
City
Newman
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
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
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
City
Broken Bow
State/Province
Nebraska
ZIP/Postal Code
68822
Country
United States
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
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
10029
Country
United States
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16176
Country
United States
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
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
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Bluefield
State/Province
West Virginia
ZIP/Postal Code
24701
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
18824288
Citation
Singh A, Patel T, Hertel J, Bernardo M, Kausz A, Brenner L. Safety of ferumoxytol in patients with anemia and CKD. Am J Kidney Dis. 2008 Nov;52(5):907-15. doi: 10.1053/j.ajkd.2008.08.001. Epub 2008 Sep 27.
Results Reference
result
Links:
URL
http://www.kidney.org/index.cfm
Description
National Kidney Foundation
Learn more about this trial
A Crossover Safety Study of Ferumoxytol Versus Placebo
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