Back to resultsFerumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease 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
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
The mean change in hemoglobin from baseline.
Secondary Outcome Measures
Change in iron indices.
Full Information
NCT ID
NCT00255424
First Posted
November 17, 2005
Last Updated
January 7, 2015
Sponsor
AMAG Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00255424
Brief Title
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients
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 Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
304 (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.
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.
Facility Information:
City
Encino
State/Province
California
ZIP/Postal Code
91356
Country
United States
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
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
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
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
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
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
18525001
Citation
Spinowitz BS, Kausz AT, Baptista J, Noble SD, Sothinathan R, Bernardo MV, Brenner L, Pereira BJ. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol. 2008 Aug;19(8):1599-605. doi: 10.1681/ASN.2007101156. Epub 2008 Jun 4.
Results Reference
result
PubMed Identifier
22874106
Citation
Fishbane S, Bolton WK, Winkelmayer WC, Strauss W, Li Z, Pereira BJ. Factors affecting response and tolerability to ferumoxytol in nondialysis chronic kidney disease patients. Clin Nephrol. 2012 Sep;78(3):181-8. doi: 10.5414/cn107397.
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 Non-Dialysis Dependent Chronic Kidney Disease Patients
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