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A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ferumoxytol
FCM
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, IDA, ferumoxytol, ferric carboxymaltose, FCM, Injectafer, Feraheme, Ferinject

Eligibility Criteria

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

Key Inclusion Criteria include:

  • Participants with IDA and in whom IV iron treatment is indicated and defined as:

    • Participants with documented hemoglobin <12.0 g per deciliter (dL) for females and <14.0 g/dL for males within 60 days of dosing And
    • Participants with documented transferrin saturation (TSAT) ≤20% or Ferritin ≤100 nanograms (ng) per mL within 60 days of dosing
  • Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate (as per oral iron history questionnaire)
  • All participants (male and female) of childbearing potential who are sexually active who agree to routinely use adequate contraception from randomization throughout the duration of the study

Key Exclusion Criteria include:

  • Known hypersensitivity reaction to any component of ferumoxytol or FCM
  • History of allergy to an IV iron
  • History of multiple drug allergies
  • Participants with dialysis-dependent chronic kidney disease
  • Hemoglobin ≤7.0 g/dL
  • Female participants who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test or not willing to use effective contraceptive precautions during the study (including females of childbearing potential who are partners of male participants)

Sites / Locations

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  • AMAG Pharmaceuticals, Inc.
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ferumoxytol

FCM

Arm Description

Participants received an IV infusion of ferumoxytol 510 milligram (mg) diluted (17 milliliter [mL]) in 233 mL 0.9% sodium chloride injection, United States Pharmacopeia (USP) (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.

Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.

Outcomes

Primary Outcome Measures

Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension
All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). Hypotension is defined as a >30% drop in systolic blood pressure from baseline or decrease of >20 mmHg for systolic blood pressure. Statistical analysis was only performed on composite data. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Secondary Outcome Measures

Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death
All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
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 5) - Hemoglobin (Baseline). 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.
Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5
Mean change in hemoglobin per g of iron administered from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). 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.

Full Information

First Posted
February 8, 2016
Last Updated
July 18, 2023
Sponsor
AMAG Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02694978
Brief Title
A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
Official Title
A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 29, 2016 (Actual)
Primary Completion Date
January 16, 2017 (Actual)
Study Completion Date
July 17, 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
To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).

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, IDA, ferumoxytol, ferric carboxymaltose, FCM, Injectafer, Feraheme, Ferinject

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2014 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferumoxytol
Arm Type
Experimental
Arm Description
Participants received an IV infusion of ferumoxytol 510 milligram (mg) diluted (17 milliliter [mL]) in 233 mL 0.9% sodium chloride injection, United States Pharmacopeia (USP) (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
Arm Title
FCM
Arm Type
Active Comparator
Arm Description
Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
Intervention Type
Drug
Intervention Name(s)
Ferumoxytol
Other Intervention Name(s)
Feraheme
Intervention Type
Drug
Intervention Name(s)
FCM
Other Intervention Name(s)
Injectafer, Ferinject
Primary Outcome Measure Information:
Title
Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension
Description
All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). Hypotension is defined as a >30% drop in systolic blood pressure from baseline or decrease of >20 mmHg for systolic blood pressure. Statistical analysis was only performed on composite data. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame
Day 1 (after first dosing) through Week 5
Secondary Outcome Measure Information:
Title
Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death
Description
All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame
Day 1 (after first dosing) through Week 5
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 5) - Hemoglobin (Baseline). 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.
Time Frame
Baseline (Day 1), Week 5
Title
Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5
Description
Mean change in hemoglobin per g of iron administered from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). 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.
Time Frame
Baseline (Day 1), Week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria include: Participants with IDA and in whom IV iron treatment is indicated and defined as: Participants with documented hemoglobin <12.0 g per deciliter (dL) for females and <14.0 g/dL for males within 60 days of dosing And Participants with documented transferrin saturation (TSAT) ≤20% or Ferritin ≤100 nanograms (ng) per mL within 60 days of dosing Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate (as per oral iron history questionnaire) All participants (male and female) of childbearing potential who are sexually active who agree to routinely use adequate contraception from randomization throughout the duration of the study Key Exclusion Criteria include: Known hypersensitivity reaction to any component of ferumoxytol or FCM History of allergy to an IV iron History of multiple drug allergies Participants with dialysis-dependent chronic kidney disease Hemoglobin ≤7.0 g/dL Female participants who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test or not willing to use effective contraceptive precautions during the study (including females of childbearing potential who are partners of male participants)
Facility Information:
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Huntsville
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Alabama
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United States
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Tucson
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Arizona
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85741
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United States
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Tucson
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Arizona
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United States
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Anaheim
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United States
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Chula Vista
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United States
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Corona
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United States
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Encino
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United States
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Fountain Valley
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California
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United States
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Granada Hills
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California
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United States
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La Mesa
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United States
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Orange
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United States
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Oxnard
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United States
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Riverside
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United States
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San Diego
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United States
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West Hollywood
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United States
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Westminster
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United States
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Bristol
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Connecticut
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United States
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Norwalk
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Connecticut
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United States
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Clearwater
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Florida
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United States
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Gainesville
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Florida
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United States
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Lauderdale Lakes
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Florida
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33313
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United States
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Lauderdale Lakes
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Florida
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United States
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Miami Lakes
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Florida
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United States
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Miami
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Florida
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33135
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United States
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Miami
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Florida
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United States
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North Miami
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Florida
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United States
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South Miami
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West Palm Beach
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Winter Haven
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Atlanta
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Georgia
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United States
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Augusta
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United States
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Savannah
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United States
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Thomasville
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Georgia
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United States
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Elk Grove Village
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United States
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Evergreen Park
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Illinois
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United States
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Hazel Crest
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Illinois
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United States
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Skokie
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Illinois
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60202
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United States
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Skokie
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Illinois
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United States
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Wichita
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United States
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Crestview Hills
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Kentucky
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United States
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Metairie
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Louisiana
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United States
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New Orleans
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United States
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Baltimore
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Maryland
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United States
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Bethesda
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Maryland
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United States
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AMAG Pharmaceuticals, Inc.
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Waltham
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Massachusetts
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02451
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United States
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Bay City
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United States
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Flint
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United States
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Saginaw
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Michigan
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48706
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United States
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Saginaw
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Michigan
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United States
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Chesterfield
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United States
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Kansas City
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United States
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Kirksville
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Missouri
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United States
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Las Vegas
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United States
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East Setauket
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United States
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Flushing
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United States
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New York
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United States
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Rosedale
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United States
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Asheville
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28801
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United States
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Asheville
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United States
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Charlotte
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United States
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Greensboro
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United States
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Hickory
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United States
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Jacksonville
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United States
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Morehead City
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United States
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Raleigh
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United States
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Wilmington
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United States
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Winston-Salem
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North Carolina
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United States
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Cincinnati
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Ohio
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45224
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United States
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Cincinnati
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Ohio
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United States
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Marion
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Ohio
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United States
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Norman
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Oklahoma
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United States
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Tulsa
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Oklahoma
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74104
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United States
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Tulsa
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Oklahoma
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United States
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Jenkintown
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Pennsylvania
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United States
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Levittown
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United States
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Scottdale
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United States
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Smithfield
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United States
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Upland
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Pennsylvania
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United States
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Greenville
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South Carolina
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29615
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United States
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Greenville
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South Carolina
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United States
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Greer
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South Carolina
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United States
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Rapid City
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South Dakota
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United States
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Germantown
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Tennessee
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United States
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Kingsport
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Tennessee
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United States
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Memphis
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Tennessee
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United States
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Austin
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Texas
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United States
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Fort Sam Houston
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Texas
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United States
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Houston
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Texas
ZIP/Postal Code
77030
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United States
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Houston
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Texas
ZIP/Postal Code
77081
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United States
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Houston
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Texas
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United States
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Longview
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Texas
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United States
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San Antonio
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Texas
ZIP/Postal Code
78215
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United States
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San Antonio
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Texas
ZIP/Postal Code
78217
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United States
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San Antonio
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Texas
ZIP/Postal Code
78229
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United States
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San Antonio
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Texas
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United States
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Schertz
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Texas
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United States
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Orem
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Utah
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United States
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Fredericksburg
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Virginia
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United States
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Norfolk
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Virginia
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United States
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Seattle
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Washington
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United States
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Sault Ste. Marie
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Ontario
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Canada
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Vaughan
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Ontario
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Canada
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Montréal
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Quebec
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Canada
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Budapest
Country
Hungary
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Debrecen
Country
Hungary
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Clinical Trial Site
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Komárom
Country
Hungary
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Clinical Trial Site
City
Szekszárd
Country
Hungary
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Vác
Country
Hungary
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Jelgava
Country
Latvia
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Clinical Trial Site
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Kraslava
Country
Latvia
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Clinical Trial Site
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Liepāja
Country
Latvia
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Clinical Trial Site
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
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Clinical Trial Site
City
Riga
ZIP/Postal Code
LV-1006
Country
Latvia
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Clinical Trial Site
City
Riga
ZIP/Postal Code
LV-1010
Country
Latvia
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Clinical Trial Site
City
Ventspils
Country
Latvia
Facility Name
Clinical Trial Site
City
Kaunas
ZIP/Postal Code
LT-44320
Country
Lithuania
Facility Name
Clinical Trial Site
City
Kaunas
ZIP/Postal Code
LT-48259
Country
Lithuania
Facility Name
Clinical Trial Site
City
Kaunas
ZIP/Postal Code
LT-49449
Country
Lithuania
Facility Name
Clinical Trial Site
City
Klaipėda
Country
Lithuania
Facility Name
Clinical Trial Site
City
Utena
Country
Lithuania
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Clinical Trial Site
City
Vilnius
Country
Lithuania
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Clinical Trial Site
City
Šiauliai
Country
Lithuania
Facility Name
Clinical Trial Site
City
Białystok
ZIP/Postal Code
15-224
Country
Poland
Facility Name
Clinical Trial Site
City
Białystok
ZIP/Postal Code
15-732
Country
Poland
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Clinical Trial Site
City
Warszawa
Country
Poland
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Clinical Trial Site
City
Wrocław
Country
Poland
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Clinical Trial Site
City
Ponce
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29417614
Citation
Adkinson NF, Strauss WE, Macdougall IC, Bernard KE, Auerbach M, Kaper RF, Chertow GM, Krop JS. Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: A randomized trial. Am J Hematol. 2018 May;93(5):683-690. doi: 10.1002/ajh.25060. Epub 2018 Feb 24.
Results Reference
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PubMed Identifier
29033620
Citation
Adkinson NF, Strauss WE, Bernard K, Kaper RF, Macdougall IC, Krop JS. Comparative safety of intravenous Ferumoxytol versus Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia: rationale and study design of a randomized double-blind study with a focus on acute hypersensitivity reactions. J Blood Med. 2017 Sep 26;8:155-163. doi: 10.2147/JBM.S142236. eCollection 2017.
Results Reference
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PubMed Identifier
30518682
Citation
Wolf M, Chertow GM, Macdougall IC, Kaper R, Krop J, Strauss W. Randomized trial of intravenous iron-induced hypophosphatemia. JCI Insight. 2018 Dec 6;3(23):e124486. doi: 10.1172/jci.insight.124486.
Results Reference
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A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)

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