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Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis

Primary Purpose

Iron Deficiency Anemia Treatment, Chronic Kidney Disease(CKD)

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ferumoxytol
Iron Sucrose
Sponsored by
AMAG Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia Treatment focused on measuring Iron deficiency anemia (IDA), chronic kidney disease (CKD), hemodialysis, magnetic resonance imaging (MRI), ferumoxytol, Feraheme

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria include:

  1. Males and females ≥18 years of age
  2. Diagnosis of CKD
  3. Subjects on dialysis must have been on dialysis for at least 3 months prior to screening
  4. Female subjects of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

  1. History of allergy to either oral or IV iron
  2. Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
  3. Parenteral iron therapy within 30 days prior to screening or red blood cell (RBC)/whole blood transfusion within 14 days prior to screening or planned during the study

Sites / Locations

  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial , contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) , or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial , contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ferumoxytol

IV Iron Sucrose

Arm Description

Intravenous (IV) iron

Intravenous (IV) iron

Outcomes

Primary Outcome Measures

Hemoglobin Changes
Changes in the mean hemoglobin between Baseline and Week 5 for ferumoxytol and iron sucrose in each treatment period.

Secondary Outcome Measures

Changes in Transferrin Saturation (TSAT)
Mean change in TSAT from TP Baseline to Week 5 for each TP
Proportion of Subjects With an Increase in Hemoglobin of ≥1.0 g/dL at Any Time From TP Baseline to Week 5 for Each TP
The proportion of subjects by group achieving a ≥1.0 g/dL increase in hemoglobin at any point during each 5-week treatment period.

Full Information

First Posted
October 22, 2010
Last Updated
March 31, 2022
Sponsor
AMAG Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01227616
Brief Title
Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis
Official Title
Ferumoxytol for Anemia of CKD Trial (FACT): A Phase IV, Open-Label, Multicenter Trial, With MRI Substudy, of Repeated Doses of Ferumoxytol Compared With Iron Sucrose for Treatment of IDA in CKD Patients on Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AMAG Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.
Detailed Description
This was a Phase IV, randomized, open-label, active-controlled, multicenter clinical trial designed to evaluate the safety, efficacy, and frequency of use of ferumoxytol compared to iron sucrose for the episodic treatment of IDA in hemodialysis subjects with CKD over a 1-year period. As part of this Main Study, an Oxidative Stress Substudy and an MRI Substudy were conducted. The Oxidative Stress Substudy, to be run concurrently with the initial TP of the Main Study, was to examine the varying degrees to which iron sucrose and ferumoxytol may or may not induce oxidative stress in vitro in subjects undergoing hemodialysis. The MRI Substudy, to be run concurrently with the Main Study and continue for an additional 11 months, was to assess the potential for deposition of iron in cardiac, hepatic, and pancreatic tissues and changes in laboratory parameters over a 2-year period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia Treatment, Chronic Kidney Disease(CKD)
Keywords
Iron deficiency anemia (IDA), chronic kidney disease (CKD), hemodialysis, magnetic resonance imaging (MRI), ferumoxytol, Feraheme

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferumoxytol
Arm Type
Experimental
Arm Description
Intravenous (IV) iron
Arm Title
IV Iron Sucrose
Arm Type
Active Comparator
Arm Description
Intravenous (IV) iron
Intervention Type
Drug
Intervention Name(s)
Ferumoxytol
Other Intervention Name(s)
Feraheme
Intervention Description
IV Ferumoxytol
Intervention Type
Drug
Intervention Name(s)
Iron Sucrose
Other Intervention Name(s)
Venofer
Intervention Description
IV Iron Sucrose
Primary Outcome Measure Information:
Title
Hemoglobin Changes
Description
Changes in the mean hemoglobin between Baseline and Week 5 for ferumoxytol and iron sucrose in each treatment period.
Time Frame
Up to 6 treatment periods (5 weeks per treatment period)
Secondary Outcome Measure Information:
Title
Changes in Transferrin Saturation (TSAT)
Description
Mean change in TSAT from TP Baseline to Week 5 for each TP
Time Frame
Up to 6 treatment periods (5 weeks per treatment period)
Title
Proportion of Subjects With an Increase in Hemoglobin of ≥1.0 g/dL at Any Time From TP Baseline to Week 5 for Each TP
Description
The proportion of subjects by group achieving a ≥1.0 g/dL increase in hemoglobin at any point during each 5-week treatment period.
Time Frame
Up to 6 treatment periods (5 weeks per treatment period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria include: Males and females ≥18 years of age Diagnosis of CKD Subjects on dialysis must have been on dialysis for at least 3 months prior to screening Female subjects of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study Key Exclusion Criteria include: History of allergy to either oral or IV iron Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test Parenteral iron therapy within 30 days prior to screening or red blood cell (RBC)/whole blood transfusion within 14 days prior to screening or planned during the study
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
San Gabriel
State/Province
California
ZIP/Postal Code
91776
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
For additional information regarding investigative sites for this trial , contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33071
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Framingham
State/Province
Massachusetts
ZIP/Postal Code
01702
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Farmington
State/Province
Missouri
ZIP/Postal Code
63640
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Bronx
State/Province
New York
ZIP/Postal Code
10641
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Ridgewood
State/Province
New York
ZIP/Postal Code
11385
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28805
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19144
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29209
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Houston
State/Province
Texas
ZIP/Postal Code
78238
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) , or speak with your personal physician
City
Montréal
Country
Canada
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Montréal
Country
Canada
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Toronto
Country
Canada
Facility Name
For additional information regarding investigative sites for this trial , contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
London
Country
United Kingdom
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30802204
Citation
Macdougall IC, Strauss WE, Dahl NV, Bernard K, Li Z. Ferumoxytol for iron deficiency anemia in patients undergoing hemodialysis. The FACT randomized controlled trial . Clin Nephrol. 2019 Apr;91(4):237-245. doi: 10.5414/CN109512.
Results Reference
result
PubMed Identifier
28372549
Citation
Macdougall IC, Dahl NV, Bernard K, Li Z, Batycky A, Strauss WE. The Ferumoxytol for Anemia of CKD Trial (FACT)-a randomized controlled trial of repeated doses of ferumoxytol or iron sucrose in patients on hemodialysis: background and rationale. BMC Nephrol. 2017 Apr 3;18(1):117. doi: 10.1186/s12882-017-0523-8. Erratum In: BMC Nephrol. 2018 Apr 26;19(1):97.
Results Reference
derived

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Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis

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