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    Clinical Trial Results:
    A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)

    Summary
    EudraCT number
    		 2016-000831-41
    Trial protocol
    		 HU   LV   LT   PL  
    Global end of trial date
    17 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Nov 2018
    First version publication date
    29 Nov 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AMAG-FER-IDA-304
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02694978
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AMAG Pharmaceuticals, Inc.
    Sponsor organisation address
    1100 Winter Street, Waltham, United States, 02451
    Public contact
    Medical Information, AMAG Pharmaceuticals, Inc., +1 877-411-2510, amag@druginfo.com
    Scientific contact
    Medical Information, AMAG Pharmaceuticals, Inc., +1 877-411-2510, amag@druginfo.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Feb 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 34
    Country: Number of subjects enrolled
    Hungary: 34
    Country: Number of subjects enrolled
    Latvia: 122
    Country: Number of subjects enrolled
    Lithuania: 111
    Country: Number of subjects enrolled
    United States: 1661
    Country: Number of subjects enrolled
    Canada: 35
    Worldwide total number of subjects
    1997
    EEA total number of subjects
    301
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1343
    From 65 to 84 years
    553
    85 years and over
    101

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants with IDA, <12.0 g per deciliter (dL) for females and <14.0 g/dL for males within 60 days of dosing and transferrin saturation <20% or Ferritin ≤100 nanograms per milliliter (mL) within 60 days of dosing and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used.

    Pre-assignment
    Screening details
    		 Participants were screened for inclusion in this study either on or up to 30 days prior to the start of dosing with study drug (either ferumoxytol or FCM).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Data analyst, Carer, Assessor
    Blinding implementation details
    This study was double blind with respect to treatment assignment; all study participants (study participant, study staff, including the physician, and all non-study individuals) with the exception of the test article preparer and the unblinded monitor were blinded to the treatment assigned to each participant.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ferumoxytol
    Arm description
    		 Participants received an IV infusion of ferumoxytol 510 milligrams (mg) diluted (17 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 type
    		 Experimental

    Investigational medicinal product name
    Ferumoxytol
    Investigational medicinal product code
    Feraheme
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) to a final volume of 250 mL, over at least 15 minutes with a second dose 7-8 days after Dose 1, for a total cumulative dose of 1.020 g.

    Arm title
    		 Ferric Carboxymaltose (FCM)
    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.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ferric Carboxymaltose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) to a final volume 250 mL, over at least 15 minutes with a second dose 7-8 days after Dose 1, for a total cumulative dose of 1.500 g.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: This study was double blind with respect to treatment assignment; all study participants (study participant, study staff, including the physician, and all non-study individuals) with the exception of the test article preparer and the unblinded monitor were blinded to the treatment assigned to each participant.
    Number of subjects in period 1
    		Ferumoxytol Ferric Carboxymaltose (FCM)
    Started
    997
    1000
    Received at Least 1 Dose of Study Drug
    997
    1000
    Completed
    935
    948
    Not completed
    62
    52
         Adverse event, serious fatal
    4
    1
         Consent withdrawn by subject
    22
    19
         Other-Decision of Participant
    6
    1
         Adverse event, non-fatal
    10
    9
         Other-Unable To Be Reached
    -
    1
         Other-Investigator's Decision
    1
    -
         Other-Personal Reasons
    3
    3
         Other-Protocol Noncompliant
    2
    1
         Lost to follow-up
    14
    17

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ferumoxytol
    Reporting group description
    		 Participants received an IV infusion of ferumoxytol 510 milligrams (mg) diluted (17 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.

    Reporting group title
    Ferric Carboxymaltose (FCM)
    Reporting group 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.

    Reporting group values
    		 Ferumoxytol Ferric Carboxymaltose (FCM) Total
    Number of subjects
    		 997 1000 1997
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 657 686 1343
        From 65-84 years
    		 286 267 553
        85 years and over
    		 54 47 101
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.6 ( 17.30 ) 54.8 ( 17.02 ) -
    Gender categorical
    Units: Subjects
        Female
    		 743 776 1519
        Male
    		 254 224 478

    End points

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    End points reporting groups
    Reporting group title
    Ferumoxytol
    Reporting group description
    		 Participants received an IV infusion of ferumoxytol 510 milligrams (mg) diluted (17 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.

    Reporting group title
    Ferric Carboxymaltose (FCM)
    Reporting group 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.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Any randomized participant who received any amount of study drug. Treatment group was based on actual treatment.

    Subject analysis set title
    Intent-to-treat (ITT) Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Any randomized participant who had any exposure to study drug, based on randomized treatment assignment.

    Primary: Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension

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    End point title
    		 Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension
    End point 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.
    End point type
    Primary
    End point timeframe
    Day 1 (after first dosing) through Week 5
    End point values
    		 Ferumoxytol Ferric Carboxymaltose (FCM)
    Number of subjects analysed
    997 [1]
    1000 [2]
    Units: Participants
        Moderate hypersensitivity reaction
    3
    6
        Severe hypersensitivity reaction
    1
    0
        Anaphylaxis
    0
    0
        Moderate hypotension
    2
    1
        Severe hypotension
    0
    0
        Any TE moderate to severe hypersensitivity rxn
    6
    7
    Notes
    [1] - Safety Population
    [2] - Safety Population
    Statistical analysis title
    		 Ferumoxytol/Ferric Carboxymaltose (FCM)
    Statistical analysis description
    Statistical analysis was only performed on composite reaction data (that is, the “Any TE moderate to severe hypersensitivity rxn” row in the data table)
    Comparison groups
    Ferumoxytol v Ferric Carboxymaltose (FCM)
    Number of subjects included in analysis
    1997
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.0001
    Method
    		 Wald large sample assumption
    Parameter type
    		 Treatment difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0.61

    Secondary: Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death

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    End point title
    		 Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death
    End point 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 CEC. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
    End point type
    Secondary
    End point timeframe
    Day 1 (after first dosing) through Week 5
    End point values
    		 Ferumoxytol Ferric Carboxymaltose (FCM)
    Number of subjects analysed
    997 [3]
    1000 [4]
    Units: Participants
        Moderate hypersensitivity reaction
    3
    6
        Severe hypersensitivity reaction
    1
    0
        Anaphylaxis
    0
    0
        Serious cardiovascular event
    6
    13
        Death
    4
    2
        Any moderate to severe hypersensitivity rxn
    13
    20
    Notes
    [3] - Safety Population
    [4] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean Change In Hemoglobin From Baseline To Week 5

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    End point title
    		 Mean Change In Hemoglobin From Baseline To Week 5
    End point 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.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 5
    End point values
    		 Ferumoxytol Ferric Carboxymaltose (FCM)
    Number of subjects analysed
    997 [5]
    1000 [6]
    Units: g/dL
    arithmetic mean (standard deviation)
        Mean Change In Hemoglobin From Baseline To Week 5
    1.38 ( 1.351 )
    1.63 ( 1.535 )
    Notes
    [5] - ITT Population
    [6] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5

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    End point title
    		 Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5
    End point 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.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 5
    End point values
    		 Ferumoxytol Ferric Carboxymaltose (FCM)
    Number of subjects analysed
    997 [7]
    1000 [8]
    Units: g/dL
    arithmetic mean (standard deviation)
        Mean Change In Hemoglobin Per Gram Of Iron Adminis
    1.35 ( 1.353 )
    1.10 ( 1.050 )
    Notes
    [7] - ITT Population
    [8] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 (after first dosing) through Week 5
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Ferumoxytol
    Reporting group description
    		 Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 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 1.020 g.

    Reporting group title
    Ferric Carboxymaltose (FCM)
    Reporting group 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.

    Serious adverse events
    		 Ferumoxytol Ferric Carboxymaltose (FCM)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 997 (3.61%)
    35 / 1000 (3.50%)
         number of deaths (all causes)
    4
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic uterine cancer
         subjects affected / exposed [1]
    0 / 743 (0.00%)
    1 / 776 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mixed hepatocellular cholangiocarcinoma
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed [2]
    1 / 743 (0.13%)
    0 / 776 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed [3]
    1 / 743 (0.13%)
    0 / 776 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Injury, poisoning and procedural complications
    Anastomotic ulcer
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-procedural haemorrhage
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1000 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1000 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure chronic
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 997 (0.10%)
    3 / 1000 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiorespiratory arrest
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Restless legs syndrome
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    2 / 997 (0.20%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    3 / 997 (0.30%)
    3 / 1000 (0.30%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic anaemia
         subjects affected / exposed
    2 / 997 (0.20%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenal ulcer
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis acute
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash maculopapular
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 997 (0.20%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    3 / 997 (0.30%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint abscess
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 997 (0.20%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis syndrome
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Fluid overload
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1000 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1000 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Only female participants in both arms were exposed to this adverse event.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Only female participants in both arms were exposed to this adverse event.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Only female participants in both arms were exposed to this adverse event.
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Ferumoxytol Ferric Carboxymaltose (FCM)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    186 / 997 (18.66%)
    245 / 1000 (24.50%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    11 / 997 (1.10%)
    16 / 1000 (1.60%)
         occurrences all number
    11
    16
    Hypertension
         subjects affected / exposed
    7 / 997 (0.70%)
    15 / 1000 (1.50%)
         occurrences all number
    7
    15
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    25 / 997 (2.51%)
    40 / 1000 (4.00%)
         occurrences all number
    31
    40
    Headache
         subjects affected / exposed
    60 / 997 (6.02%)
    82 / 1000 (8.20%)
         occurrences all number
    70
    90
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    8 / 997 (0.80%)
    11 / 1000 (1.10%)
         occurrences all number
    9
    11
    Chest pain
         subjects affected / exposed
    10 / 997 (1.00%)
    4 / 1000 (0.40%)
         occurrences all number
    10
    4
    Fatigue
         subjects affected / exposed
    30 / 997 (3.01%)
    36 / 1000 (3.60%)
         occurrences all number
    32
    38
    Pyrexia
         subjects affected / exposed
    7 / 997 (0.70%)
    22 / 1000 (2.20%)
         occurrences all number
    7
    23
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    17 / 997 (1.71%)
    21 / 1000 (2.10%)
         occurrences all number
    18
    23
    Constipation
         subjects affected / exposed
    14 / 997 (1.40%)
    13 / 1000 (1.30%)
         occurrences all number
    14
    13
    Diarrhoea
         subjects affected / exposed
    29 / 997 (2.91%)
    33 / 1000 (3.30%)
         occurrences all number
    29
    37
    Nausea
         subjects affected / exposed
    35 / 997 (3.51%)
    60 / 1000 (6.00%)
         occurrences all number
    39
    69
    Vomiting
         subjects affected / exposed
    11 / 997 (1.10%)
    13 / 1000 (1.30%)
         occurrences all number
    11
    15
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    15 / 997 (1.50%)
    13 / 1000 (1.30%)
         occurrences all number
    17
    14
    Dyspnoea
         subjects affected / exposed
    11 / 997 (1.10%)
    18 / 1000 (1.80%)
         occurrences all number
    11
    19
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    12 / 997 (1.20%)
    11 / 1000 (1.10%)
         occurrences all number
    15
    11
    Urticaria
         subjects affected / exposed
    3 / 997 (0.30%)
    13 / 1000 (1.30%)
         occurrences all number
    3
    13
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    14 / 997 (1.40%)
    12 / 1000 (1.20%)
         occurrences all number
    16
    12
    Back pain
         subjects affected / exposed
    19 / 997 (1.91%)
    16 / 1000 (1.60%)
         occurrences all number
    23
    16
    Metabolism and nutrition disorders
    Hypophosphataemia
         subjects affected / exposed
    0 / 997 (0.00%)
    18 / 1000 (1.80%)
         occurrences all number
    0
    18

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29417614
    http://www.ncbi.nlm.nih.gov/pubmed/29033620
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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