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A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ferumoxytol
Placebo
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 focused on measuring Iron deficiency anemia, Feraheme, ferumoxytol, IDA

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. Participants with IDA defined as having:

    1. Hemoglobin <10.0 g/deciliter (dL)
    2. Transferrin saturation <20%
  3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
  4. Female participants 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 IV iron
  2. Allergy to two or more classes of drugs
  3. Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute/1.73 m^2
  4. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
  5. Hemoglobin ≤7.0 g/dL
  6. Serum ferritin >600 nanograms/mL

Sites / Locations

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  • AMAG Pharmaceuticals, Inc.
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ferumoxytol

Placebo

Arm Description

Participants received a total of 2 doses of IV ferumoxytol 510 milligrams (mg) (17 milliliters [mL]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 grams (g).

Participants received a total of 2 doses of IV saline (17 mL). The first IV dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose.

Outcomes

Primary Outcome Measures

Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase. Statistical analysis was performed for data up to Week 5 only.

Secondary Outcome Measures

Mean Change In Hemoglobin From Baseline To Week 5
Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero. Participants without any post-Baseline hemoglobin values were treated as non-responders.
Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5
Participants who achieved a ≥12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants without any post-Baseline hemoglobin values were treated as non-responders.
Mean Change In TSAT From Baseline To Week 5
Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) - TSAT (Baseline). TSAT, measured as a percentage, was part of the iron panel laboratory evaluations. Of the transferrin available to bind iron, this value indicates how much serum iron is bound. For example, a value of 20% means that 20% of iron-binding sites of transferrin are being occupied by iron. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero.
Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5
The FACIT-Fatigue questionnaire is a 13-item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue. Mean change in FACIT-Fatigue Score from Baseline to Week 5 was calculated for each participant as: FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline). Baseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero.
Time To Hemoglobin Increase Of ≥2.0 g/dL Or A Hemoglobin Value Of ≥12.0 g/dL From Baseline
The time to hemoglobin increase of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of ≥2.0 g/dL or to a hemoglobin level ≥12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included.

Full Information

First Posted
April 29, 2010
Last Updated
March 31, 2022
Sponsor
AMAG Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01114139
Brief Title
A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 19, 2010 (Actual)
Primary Completion Date
February 27, 2012 (Actual)
Study Completion Date
October 22, 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).
Detailed Description
This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical study evaluated the safety and efficacy of ferumoxytol compared with placebo for the treatment of IDA, specifically in adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. The effect of ferumoxytol on hemoglobin, iron parameters and patient reported outcomes (PROs) compared with placebo was evaluated. Investigators were blinded to key laboratory parameters that could potentially unblind the treatment arms of the study, eg, hemoglobin [Hgb], hematocrit [Hct], iron, ferritin, total iron binding capacity [TIBC], and transferrin saturation [TSAT], and neither the Investigators nor the subjects were aware of their treatment assignment, hemoglobin or other laboratory values.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
Iron deficiency anemia, Feraheme, ferumoxytol, IDA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
812 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferumoxytol
Arm Type
Experimental
Arm Description
Participants received a total of 2 doses of IV ferumoxytol 510 milligrams (mg) (17 milliliters [mL]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 grams (g).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received a total of 2 doses of IV saline (17 mL). The first IV dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose.
Intervention Type
Drug
Intervention Name(s)
Ferumoxytol
Other Intervention Name(s)
Feraheme
Intervention Description
IV Ferumoxytol
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
IV Placebo
Primary Outcome Measure Information:
Title
Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
Description
Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase. Statistical analysis was performed for data up to Week 5 only.
Time Frame
Baseline (Day 1) through Week 5
Secondary Outcome Measure Information:
Title
Mean Change In Hemoglobin From Baseline To Week 5
Description
Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero. Participants without any post-Baseline hemoglobin values were treated as non-responders.
Time Frame
Baseline (Day 1), Week 5
Title
Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5
Description
Participants who achieved a ≥12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants without any post-Baseline hemoglobin values were treated as non-responders.
Time Frame
Baseline (Day 1) through Week 5
Title
Mean Change In TSAT From Baseline To Week 5
Description
Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) - TSAT (Baseline). TSAT, measured as a percentage, was part of the iron panel laboratory evaluations. Of the transferrin available to bind iron, this value indicates how much serum iron is bound. For example, a value of 20% means that 20% of iron-binding sites of transferrin are being occupied by iron. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero.
Time Frame
Baseline (Day 1), Week 5
Title
Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5
Description
The FACIT-Fatigue questionnaire is a 13-item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue. Mean change in FACIT-Fatigue Score from Baseline to Week 5 was calculated for each participant as: FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline). Baseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero.
Time Frame
Baseline (Day 1), Week 5
Title
Time To Hemoglobin Increase Of ≥2.0 g/dL Or A Hemoglobin Value Of ≥12.0 g/dL From Baseline
Description
The time to hemoglobin increase of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of ≥2.0 g/dL or to a hemoglobin level ≥12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included.
Time Frame
From Baseline (Day 1) up to Week 5

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 Participants with IDA defined as having: Hemoglobin <10.0 g/deciliter (dL) Transferrin saturation <20% Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used Female participants 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 IV iron Allergy to two or more classes of drugs Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute/1.73 m^2 Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test Hemoglobin ≤7.0 g/dL Serum ferritin >600 nanograms/mL
Facility Information:
Facility Name
Clinical Trial Site
City
Birmingham
State/Province
Alabama
Country
United States
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Clinical Trial Site
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Mobile
State/Province
Alabama
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United States
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Clinical Trial Site
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Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
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United States
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Montgomery
State/Province
Alabama
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United States
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Green Valley
State/Province
Arizona
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United States
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Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
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United States
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City
Phoenix
State/Province
Arizona
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United States
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Tucson
State/Province
Arizona
ZIP/Postal Code
85710
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United States
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Tucson
State/Province
Arizona
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United States
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Alhambra
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California
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United States
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Anaheim
State/Province
California
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United States
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Bakersfield
State/Province
California
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United States
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Buena Park
State/Province
California
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United States
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Colton
State/Province
California
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United States
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Fresno
State/Province
California
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United States
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Glendale
State/Province
California
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United States
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Laguna Hills
State/Province
California
ZIP/Postal Code
92653
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United States
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Laguna Hills
State/Province
California
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United States
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Lakewood
State/Province
California
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United States
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Los Angeles
State/Province
California
ZIP/Postal Code
90036
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United States
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Los Angeles
State/Province
California
ZIP/Postal Code
90057
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United States
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Los Angeles
State/Province
California
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United States
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Mission Hills
State/Province
California
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United States
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Orange
State/Province
California
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United States
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San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
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Clinical Trial Site
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San Diego
State/Province
California
ZIP/Postal Code
92123
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United States
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Clinical Trial Site
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San Diego
State/Province
California
Country
United States
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City
Pueblo
State/Province
Colorado
Country
United States
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City
Bristol
State/Province
Connecticut
Country
United States
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Groton
State/Province
Connecticut
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United States
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City
Newark
State/Province
Delaware
Country
United States
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City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Clinical Trial Site
City
Boynton Beach
State/Province
Florida
Country
United States
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Clinical Trial Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Clinical Trial Site
City
Clearwater
State/Province
Florida
Country
United States
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City
Hialeah
State/Province
Florida
Country
United States
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City
Holiday
State/Province
Florida
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United States
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City
Inverness
State/Province
Florida
Country
United States
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City
Margate
State/Province
Florida
Country
United States
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Miami Lakes
State/Province
Florida
Country
United States
Facility Name
Clinical Trial Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Clinical Trial Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Clinical Trial Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Clinical Trial Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Clinical Trial Site
City
Miami
State/Province
Florida
Country
United States
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Clinical Trial Site
City
Naples
State/Province
Florida
Country
United States
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Clinical Trial Site
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Ocala
State/Province
Florida
Country
United States
Facility Name
Clinical Trial Site
City
Vero Beach
State/Province
Florida
Country
United States
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Clinical Trial Site
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Clinical Trial Site
City
Wellington
State/Province
Florida
Country
United States
Facility Name
Clinical Trial Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Clinical Trial Site
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
Clinical Trial Site
City
Zephyrhills
State/Province
Florida
Country
United States
Facility Name
Clinical Trial Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Clinical Trial Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Clinical Trial Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Clinical Trial Site
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
Clinical Trial Site
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
Clinical Trial Site
City
Dublin
State/Province
Georgia
Country
United States
Facility Name
Clinical Trial Site
City
Rome
State/Province
Georgia
Country
United States
Facility Name
Clinical Trial Site
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Sandy Springs
State/Province
Georgia
Country
United States
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Savannah
State/Province
Georgia
Country
United States
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Stockbridge
State/Province
Georgia
Country
United States
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City
Aurora
State/Province
Illinois
Country
United States
Facility Name
Clinical Trial Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Clinical Trial Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Clinical Trial Site
City
Evergreen Park
State/Province
Illinois
Country
United States
Facility Name
Clinical Trial Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Clinical Trial Site
City
Skokie
State/Province
Illinois
Country
United States
Facility Name
Clinical Trial Site
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Clinical Trial Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Clinical Trial Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Clinical Trial Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Clinical Trial Site
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
Clinical Trial Site
City
Hollywood
State/Province
Maryland
Country
United States
Facility Name
Clinical Trial Site
City
Prince Frederick
State/Province
Maryland
Country
United States
Facility Name
AMAG Pharmaceuticals, Inc.
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Clinical Trial Site
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Clinical Trial Site
City
Bay City
State/Province
Michigan
Country
United States
Facility Name
Clinical Trial Site
City
Saginaw
State/Province
Michigan
Country
United States
Facility Name
Clinical Trial Site
City
Wyoming
State/Province
Michigan
Country
United States
Facility Name
Clinical Trial Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Clinical Trial Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Clinical Trial Site
City
Lawrenceville
State/Province
New Jersey
Country
United States
Facility Name
Clinical Trial Site
City
Neptune
State/Province
New Jersey
Country
United States
Facility Name
Clinical Trial Site
City
Plainsboro
State/Province
New Jersey
Country
United States
Facility Name
Clinical Trial Site
City
Somerville
State/Province
New Jersey
Country
United States
Facility Name
Clinical Trial Site
City
Voorhees
State/Province
New Jersey
Country
United States
Facility Name
Clinical Trial Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Clinical Trial Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Clinical Trial Site
City
Goshen
State/Province
New York
Country
United States
Facility Name
Clinical Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10038
Country
United States
Facility Name
Clinical Trial Site
City
New York
State/Province
New York
Country
United States
Facility Name
Clinical Trial Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Clinical Trial Site
City
Wilmington
State/Province
North Carolina
Country
United States
Facility Name
Clinical Trial Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Clinical Trial Site
City
Bismarck
State/Province
North Dakota
Country
United States
Facility Name
Clinical Trial Site
City
Akron
State/Province
Ohio
Country
United States
Facility Name
Clinical Trial Site
City
Beavercreek
State/Province
Ohio
Country
United States
Facility Name
Clinical Trial Site
City
Canton
State/Province
Ohio
Country
United States
Facility Name
Clinical Trial Site
City
Carlisle
State/Province
Ohio
Country
United States
Facility Name
Clinical Trial Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45202
Country
United States
Facility Name
Clinical Trial Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Clinical Trial Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Clinical Trial Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Clinical Trial Site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Clinical Trial Site
City
Marion
State/Province
Ohio
Country
United States
Facility Name
Clinical Trial Site
City
Mentor
State/Province
Ohio
Country
United States
Facility Name
Clinical Trial Site
City
Middletown
State/Province
Ohio
Country
United States
Facility Name
Clinical Trial Site
City
Zanesville
State/Province
Ohio
Country
United States
Facility Name
Clinical Trial Site
City
Norman
State/Province
Oklahoma
Country
United States
Facility Name
Clinical Trial Site
City
Jenkintown
State/Province
Pennsylvania
Country
United States
Facility Name
Clinical Trial Site
City
Levittown
State/Province
Pennsylvania
Country
United States
Facility Name
Clinical Trial Site
City
East Providence
State/Province
Rhode Island
Country
United States
Facility Name
Clinical Trial Site
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Clinical Trial Site
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
Clinical Trial Site
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
Clinical Trial Site
City
North Charleston
State/Province
South Carolina
Country
United States
Facility Name
Clinical Trial Site
City
Orangeburg
State/Province
South Carolina
Country
United States
Facility Name
Clinical Trial Site
City
Rapid City
State/Province
South Dakota
Country
United States
Facility Name
Clinical Trial Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Clinical Trial Site
City
Arlington
State/Province
Texas
Country
United States
Facility Name
Clinical Trial Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Clinical Trial Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Trial Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Clinical Trial Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Clinical Trial Site
City
Laredo
State/Province
Texas
Country
United States
Facility Name
Clinical Trial Site
City
Longview
State/Province
Texas
Country
United States
Facility Name
Clinical Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Clinical Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Clinical Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Clinical Trial Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Clinical Trial Site
City
Spring
State/Province
Texas
Country
United States
Facility Name
Clinical Trial Site
City
Orem
State/Province
Utah
Country
United States
Facility Name
Clinical Trial Site
City
Chesapeake
State/Province
Virginia
Country
United States
Facility Name
Clinical Trial Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Clinical Trial Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Clinical Trial Site
City
Saint John
State/Province
New Brunswick
Country
Canada
Facility Name
Clinical Trial Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Clinical Trial Site
City
Scarborough
State/Province
Ontario
Country
Canada
Facility Name
Clinical Trial Site
City
Thornhill
State/Province
Ontario
Country
Canada
Facility Name
Clinical Trial Site
City
Vaughan
State/Province
Ontario
Country
Canada
Facility Name
Clinical Trial Site
City
Pointe-Claire
State/Province
Quebec
Country
Canada
Facility Name
Clinical Trial Site
City
Békéscsaba
Country
Hungary
Facility Name
Clinical Trial Site
City
Gyula
Country
Hungary
Facility Name
Clinical Trial Site
City
Komárom
Country
Hungary
Facility Name
Clinical Trial Site
City
Szekszárd
Country
Hungary
Facility Name
Clinical Trial Site
City
Vác
Country
Hungary
Facility Name
Clinical Trial Site
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
Clinical Trial Site
City
Secunderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
Clinical Trial Site
City
Visakhapatnam
State/Province
Andhrapradesh
Country
India
Facility Name
Clinical Trial Site
City
Guwahati
State/Province
Assam
Country
India
Facility Name
Clinical Trial Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
Facility Name
Clinical Trial Site
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Clinical Trial Site
City
Mangalore
State/Province
Karnataka
Country
India
Facility Name
Clinical Trial Site
City
Aurangabad
State/Province
Maharashtra
Country
India
Facility Name
Clinical Trial Site
City
Nagpur
State/Province
Maharashtra
Country
India
Facility Name
Clinical Trial Site
City
Nashik
State/Province
Maharashtra
Country
India
Facility Name
Clinical Trial Site
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Clinical Trial Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302001
Country
India
Facility Name
Clinical Trial Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302013
Country
India
Facility Name
Clinical Trial Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600096
Country
India
Facility Name
Clinical Trial Site
City
Chennai
State/Province
Tamil Nadu
Country
India
Facility Name
Clinical Trial Site
City
Coimbatore
State/Province
Tamil Nadu
Country
India
Facility Name
Clinical Trial Site
City
Madurai
State/Province
Tamil Nadu
Country
India
Facility Name
Clinical Trial Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Clinical Trial Site
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Facility Name
Clinical Trial Site
City
Daugavpils
Country
Latvia
Facility Name
Clinical Trial Site
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Clinical Trial Site
City
Riga
ZIP/Postal Code
LV-1005
Country
Latvia
Facility Name
Clinical Trial Site
City
Riga
ZIP/Postal Code
LV-1006
Country
Latvia
Facility Name
Clinical Trial Site
City
Riga
ZIP/Postal Code
LV-1010
Country
Latvia
Facility Name
Clinical Trial Site
City
Valmiera
ZIP/Postal Code
LV-4201
Country
Latvia
Facility Name
Clinical Trial Site
City
Ventspils
ZIP/Postal Code
LV-3601
Country
Latvia
Facility Name
Clinical Trial Site
City
Ventspils
Country
Latvia
Facility Name
Clinical Trial Site
City
Białystok
Country
Poland
Facility Name
Clinical Trial Site
City
Sopot
Country
Poland
Facility Name
Clinical Trial Site
City
Warszawa
ZIP/Postal Code
02-341
Country
Poland
Facility Name
Clinical Trial Site
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Clinical Trial Site
City
Wrocław
Country
Poland
Facility Name
Clinical Trial Site
City
Zgierz
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23983177
Citation
Vadhan-Raj S, Strauss W, Ford D, Bernard K, Boccia R, Li J, Allen LF. Efficacy and safety of IV ferumoxytol for adults with iron deficiency anemia previously unresponsive to or unable to tolerate oral iron. Am J Hematol. 2014 Jan;89(1):7-12. doi: 10.1002/ajh.23582. Epub 2013 Sep 30.
Results Reference
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Learn more about this trial

A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia

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