Iron Deficiency AnemiaPhase 3NCT02694978
A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
A Phase 3 study testing Ferumoxytol and FCM in people with Iron Deficiency Anemia, run by AMAG Pharmaceuticals, Inc. at 127 sites in 7 countries.
Trial summary
To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferumoxytol and FCM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,014 participants
- Where
- 127 sitesin 7 countries
- Study dates
- 29 Feb 2016to 17 Jul 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
127 sites in 7 countries.
127 sites in 7 countries
United States100 sites
Clinical Trial Site
Anaheim, California
Clinical Trial Site
Asheville, North Carolina, 28801
Clinical Trial Site
Asheville, North Carolina
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Atlanta, Georgia
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Augusta, Georgia
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Austin, Texas
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Baltimore, Maryland
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Bay City, Michigan
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Bethesda, Maryland
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Bristol, Connecticut
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Charlotte, North Carolina
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Chesterfield, Missouri
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Chula Vista, California
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Cincinnati, Ohio, 45224
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Cincinnati, Ohio
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Clearwater, Florida
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Corona, California
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Crestview Hills, Kentucky
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East Setauket, New York
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Elk Grove Village, Illinois
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Encino, California
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Evergreen Park, Illinois
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Flint, Michigan
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Flushing, New York
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Fort Sam Houston, Texas
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Fountain Valley, California
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Fredericksburg, Virginia
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Gainesville, Florida
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Germantown, Tennessee
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Granada Hills, California
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Greensboro, North Carolina
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Greenville, South Carolina, 29615
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Greenville, South Carolina
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Greer, South Carolina
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Hazel Crest, Illinois
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Hickory, North Carolina
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Houston, Texas, 77030
Clinical Trial Site
Houston, Texas, 77081
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Houston, Texas
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Huntsville, Alabama
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Jacksonville, North Carolina
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Jenkintown, Pennsylvania
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Kansas City, Missouri
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Kingsport, Tennessee
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Kirksville, Missouri
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La Mesa, California
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Las Vegas, Nevada
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Lauderdale Lakes, Florida, 33313
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Lauderdale Lakes, Florida
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Levittown, Pennsylvania
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Longview, Texas
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Marion, Ohio
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Memphis, Tennessee
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Metairie, Louisiana
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Miami, Florida, 33135
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Miami, Florida
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Miami Lakes, Florida
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Morehead City, North Carolina
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New Orleans, Louisiana
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New York, New York
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Norfolk, Virginia
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Norman, Oklahoma
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North Miami, Florida
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Norwalk, Connecticut
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Orange, California
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Orem, Utah
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Oxnard, California
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Raleigh, North Carolina
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Rapid City, South Dakota
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Riverside, California
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Rosedale, New York
Clinical Trial Site
Saginaw, Michigan, 48706
Clinical Trial Site
Saginaw, Michigan
Clinical Trial Site
San Antonio, Texas, 78215
Clinical Trial Site
San Antonio, Texas, 78217
Clinical Trial Site
San Antonio, Texas, 78229
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San Antonio, Texas
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San Diego, California
Clinical Trial Site
Savannah, Georgia
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Schertz, Texas
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Scottdale, Pennsylvania
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Seattle, Washington
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Skokie, Illinois, 60202
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Skokie, Illinois
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Smithfield, Pennsylvania
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South Miami, Florida
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Thomasville, Georgia
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Tucson, Arizona, 85741
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Tucson, Arizona
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Tulsa, Oklahoma, 74104
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Tulsa, Oklahoma
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Upland, Pennsylvania
AMAG Pharmaceuticals, Inc.
Waltham, Massachusetts, 02451
Clinical Trial Site
West Hollywood, California
Clinical Trial Site
West Palm Beach, Florida
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Westminster, California
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Wichita, Kansas
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Wilmington, North Carolina
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Winston-Salem, North Carolina
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Winter Haven, Florida
Latvia7 sites
Clinical Trial Site
Jelgava
Clinical Trial Site
Krāslava
Clinical Trial Site
Liepāja
Clinical Trial Site
Riga, LV-1002
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Riga, LV-1006
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Riga, LV-1010
Clinical Trial Site
Ventspils
Lithuania7 sites
Clinical Trial Site
Kaunas, LT-44320
Clinical Trial Site
Kaunas, LT-48259
Clinical Trial Site
Kaunas, LT-49449
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Klaipėda
Clinical Trial Site
Šiauliai
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Utena
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Vilnius
Hungary5 sites
Clinical Trial Site
Budapest
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Debrecen
Clinical Trial Site
Komárom
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Szekszárd
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Vác
Poland4 sites
Clinical Trial Site
Bialystok, 15-224
Clinical Trial Site
Bialystok, 15-732
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Warsaw
Clinical Trial Site
Wroclaw
Canada3 sites
Clinical Trial Site
Montreal, Quebec
Clinical Trial Site
Sault Ste. Marie, Ontario
Clinical Trial Site
Vaughan, Ontario
About this study
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)
To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).
- Conditions
- Iron Deficiency Anemia
- Being tested
- Ferumoxytol, FCM
- Keywords
- iron deficiency anemia, IDA, ferumoxytol, ferric carboxymaltose, FCM, Injectafer, Feraheme, Ferinject
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerumoxytolDrug
Also called Feraheme
FCMDrug
Also called Injectafer, Ferinject
| Study group | Role | What they receive |
|---|---|---|
| Ferumoxytol | Experimental | 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. Receives: Drug: Ferumoxytol |
| FCM | Active comparator | 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. Receives: Drug: FCM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (after first dosing) through Week 5
Secondary outcomes (3)
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.
Measured: Day 1 (after first dosing) through Week 5
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.
Measured: Baseline (Day 1), Week 5
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.
Measured: Baseline (Day 1), Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study start29 Feb 2016
- Primary completion16 Jan 2017
- Study completion17 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- AMAG Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694978
- Sponsor's protocol ID
- AMAG-FER-IDA-304
- Status last verified
- Jul 2023
- First submitted
- 8 Feb 2016
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29417614Adkinson 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.
PubMed 29033620Wolf 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.
PubMed 30518682
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02694978
- Acronym / sponsor ID
- AMAG-FER-IDA-304
- Conditions
- Iron Deficiency Anemia
- Keywords
- iron deficiency anemia, IDA, ferumoxytol, ferric carboxymaltose, FCM, Injectafer, Feraheme, Ferinject
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,014 participants (actual)
- Lead sponsor
- AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 16 Jan 2017 (actual)
- Study completion
- 17 Jul 2017 (actual)
- First posted
- 1 Mar 2016 (estimated)
- Results
- Posted 11 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferumoxytol | Experimental | Drug: FerumoxytolParticipants 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. |
| FCM | Active comparator | Drug: FCMParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants with IDA and in whom IV iron treatment is indicated and defined as:
- 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 (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerumoxytolAlso: Feraheme | Drug | Ferumoxytol |
| FCMAlso: Injectafer, Ferinject | Drug | FCM |
Primary outcome
Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension
Time frame: Day 1 (after first dosing) through Week 5
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.
3 secondary outcomes
Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death
Time frame: Day 1 (after first dosing) through Week 5
Mean Change In Hemoglobin From Baseline To Week 5
Time frame: Baseline (Day 1), Week 5
Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5
Time frame: Baseline (Day 1), Week 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29417614Adkinson 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.
- Background: PubMed 29033620Adkinson 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.
- Derived from this study: PubMed 30518682Wolf 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
127 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferumoxytol and FCM in people with Iron Deficiency Anemia, run by AMAG Pharmaceuticals, Inc. at 127 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 127 sites in United States, Latvia, Lithuania, Hungary, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension (time frame: Day 1 (after first dosing) through Week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694978, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.