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    Clinical Trial Results:
    Ferumoxytol for Anemia of CKD Trial (FACT): A Phase IV, Open-Label, Multicenter Trial, with MRI Substudy, of Repeated Doses of Ferumoxytol Compared with Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA) in Chronic Kidney Disease (CKD) Patients on Hemodialysis

    Summary
    EudraCT number
    		 2010-022133-28
    Trial protocol
    		 GB  
    Global end of trial date
    24 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Nov 2017
    First version publication date
    25 Nov 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AMAG-FER-CKD-401
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01227616
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AMAG Pharmaceuticals Inc.
    Sponsor organisation address
    1100 Winter St., Waltham, United States, MA 02451
    Public contact
    FACT Study Info, AMAG Pharmaceuticals Inc., factstudyinfo@amagpharma.com
    Scientific contact
    FACT Study Info, AMAG Pharmaceuticals Inc., factstudyinfo@amagpharma.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
    17 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that 1.02 g courses of ferumoxytol (delivered as either an undiluted IV injection or diluted IV infusion of 510 mg each) are noninferior to 1.0 g courses of iron sucrose (delivered either as slow IV undiluted injections or IV diluted infusions of 100 mg each) in raising hemoglobin after each treatment period in hemodialysis-dependent CKD subjects with IDA over a one-year period
    Protection of trial subjects
    Female subjects of childbearing potential who are not on an effective method of birth control or female subjects who are pregnant or intend to become pregnant, breastfeeding, within 2 weeks postpartum, or have a positive serum or urine pregnancy test will not be allowed to participate in this study. For those subjects not previously exposed to iron sucrose, a test dose will be administered o For IV drip infusion the first 20-25 mg of iron should be infused over a period of approximately 15 minutes. If no adverse reactions occur during this time then the remaining portion of the infusion should be given at an infusion rate of not more than 100 mg over 15 minutes o For a slow IV injection, a test dose of 1 mL (~20 mg of iron) should be injected slowly over a period of approximately 1 minute. If no adverse reactions occur within 15 minutes of completing the test dose, then the remaining portion of the injection may be given
    Background therapy
    		 -
    Evidence for comparator
    		 Iron sucrose for injection is currently approved in over 79 countries, including the US, EU and Canada as an IV iron replacement therapy for patients with CKD and IDA. Iron sucrose for injection is currently the most frequently prescribed IV iron therapy worldwide. The 100 mg dose of iron sucrose to be administered in this trial is consistent with the approved and marketed doses of iron sucrose worldwide. It has been shown to significantly increase hemoglobin levels as early as 15 days after dosing, with a mean change in hemoglobin of 1.0-1.3 g/dL from Baseline to Week 8.
    Actual start date of recruitment
    19 Aug 2013
    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
    United Kingdom: 11
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    United States: 275
    Worldwide total number of subjects
    293
    EEA total number of subjects
    11
    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)
    192
    From 65 to 84 years
    95
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 296 hemodialysis patients with IDA who met the entry criteria were enrolled and randomized (ferumoxytol: n=197; iron sucrose: n=99). One subject in the ferumoxytol group and 2 subjects in the iron sucrose group withdrew prior to receiving study drug

    Pre-assignment
    Screening details
    		 2-week Screening Period, male and female hemodialysis subjects ≥18 years of age with IDA and CKD, with screening hemoglobin values of <11.5 g/dL and TSAT <30% who met the other inclusion criteria and did not satisfy any exclusion criteria were eligible for the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ferumoxytol
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Feraheme
    Investigational medicinal product code
    Other name
    ferumoxytol
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects assigned to the ferumoxytol treatment group will receive ferumoxytol as a diluted IV infusion as follows: 510 mg ferumoxytol on Day 1 and then a second dose 2 to 8 days later (TP Day 3 to 9), for a total cumulative dose of 1.02 g

    Arm title
    		 Iron Sucrose
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Iron Sucrose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    iron sucrose treatment group received iron sucrose as a slow undiluted IV injection or diluted IV infusion as follows: 100 mg iron sucrose on Day 1 and at the following 9 consecutive hemodialysis sessions over approximately 3 weeks for a total cumulative dose of 1.0 g.

    Number of subjects in period 1
    		Ferumoxytol Iron Sucrose
    Started
    196
    97
    Evaluable Population
    181
    83
    Completed
    142
    74
    Not completed
    54
    23
         Consent withdrawn by subject
    10
    7
         Adverse event, non-fatal
    8
    2
         Other
    20
    8
         Death
    13
    5
         Lost to follow-up
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ferumoxytol
    Reporting group description
    		 -

    Reporting group title
    Iron Sucrose
    Reporting group description
    		 -

    Reporting group values
    		 Ferumoxytol Iron Sucrose Total
    Number of subjects
    		 196 97 293
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.3 ( 14.13 ) 57.6 ( 13.62 ) -
    Gender categorical
    Units: Subjects
        Female
    		 114 57 171
        Male
    		 82 40 122
    Race
    Units: Subjects
        White
    		 101 47 148
        Black or African American
    		 62 26 88
        Asian
    		 15 13 28
        American Indian or Alaska Native
    		 10 4 14
        Other/Multiracial
    		 6 4 10
        Native Hawaiian or Other Pacific Islander
    		 2 3 5
    Ethnicity
    Units: Subjects
        Hispanic and/or Latino
    		 68 40 108
        Not Hispanic or Latino
    		 128 57 185
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 168.3 ( 10.49 ) 167.2 ( 10.39 ) -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 86.8 ( 23.4 ) 83.2 ( 20.95 ) -

    End points

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    End points reporting groups
    Reporting group title
    Ferumoxytol
    Reporting group description
    		 -

    Reporting group title
    Iron Sucrose
    Reporting group description
    		 -

    Subject analysis set title
    Evaluable Population- Ferumoxytol
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Any randomized subjects who met the following criteria: • Did not have any significant protocol violations/deviations considered to impact study integrity • Received 2 doses of ferumoxytol or all 10 doses of iron sucrose in TP1 • Had data for hemoglobin (primary endpoint) at TP1 Baseline and Week 5 • Confirmatory analyses for the primary efficacy were performed in the Evaluable Population.

    Subject analysis set title
    Evaluable Population- Iron Sucrose
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Any randomized subjects who met the following criteria: • Did not have any significant protocol violations/deviations considered to impact study integrity • Received 2 doses of ferumoxytol or all 10 doses of iron sucrose in TP1 • Had data for hemoglobin (primary endpoint) at TP1 Baseline and Week 5 • Confirmatory analyses for the primary efficacy were performed in the Evaluable Population.

    Primary: Mean Change in Hemoglobin at Week 5: TP1

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    End point title
    		 Mean Change in Hemoglobin at Week 5: TP1
    End point description
    Mean change in hemoglobin from TP Baseline (defined as the hemoglobin level immediately prior to each treatment course) to Week 5 was non-inferior for ferumoxytol compared to iron sucrose in treatment period 1.
    End point type
    Primary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose Evaluable Population- Ferumoxytol Evaluable Population- Iron Sucrose
    Number of subjects analysed
    195
    94
    180
    82
    Units: gram(s)/decilitre
        arithmetic mean (standard deviation)
    0.5 ( 0.97 )
    0.4 ( 0.97 )
    0.5 ( 0.96 )
    0.5 ( 0.89 )
    Statistical analysis title
    		 LS mean and 95% Confidence Interval for difference
    Comparison groups
    Ferumoxytol v Iron Sucrose
    Number of subjects included in analysis
    289
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.2811
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.36
    Notes
    [1] - The study protocol defined the margin for non-inferiority as 0.5 g/dL meaning non–inferiority would be established in a TP if the lower limit of the 95% confidence limit for the difference between ferumoxytol and iron sucrose mean change was ≥0.5 g/dL.
    Statistical analysis title
    		 Copy of LS mean and 95% Confidence Interval for...
    Comparison groups
    Evaluable Population- Ferumoxytol v Evaluable Population- Iron Sucrose
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 = 0.6968
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.29
    Notes
    [2] - The study protocol defined the margin for non-inferiority as 0.5 g/dL meaning non–inferiority would be established in a TP if the lower limit of the 95% confidence limit for the difference between ferumoxytol and iron sucrose mean change was ≥0.5 g/dL.

    Primary: Mean Change in Hemoglobin at Week 5: TP2

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    End point title
    		 Mean Change in Hemoglobin at Week 5: TP2
    End point description
    Mean change in hemoglobin from TP Baseline (defined as the hemoglobin level immediately prior to each treatment course) to Week 5 was non-inferior for ferumoxytol compared to iron sucrose in treatment period 2.
    End point type
    Primary
    End point timeframe
    Baseline (start of treatment period) to week 5
    End point values
    		 Ferumoxytol Iron Sucrose Evaluable Population- Ferumoxytol Evaluable Population- Iron Sucrose
    Number of subjects analysed
    167
    88
    159
    76
    Units: gram(s)/decilitre
        arithmetic mean (standard deviation)
    0.6 ( 0.96 )
    0.3 ( 1.03 )
    0.5 ( 0.96 )
    0.3 ( 1.1 )
    Statistical analysis title
    		 LS mean and 95% Confidence Interval for difference
    Comparison groups
    Ferumoxytol v Iron Sucrose
    Number of subjects included in analysis
    255
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0158
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 0.55
    Statistical analysis title
    		 Copy of LS mean and 95% Confidence Interval for...
    Comparison groups
    Evaluable Population- Ferumoxytol v Evaluable Population- Iron Sucrose
    Number of subjects included in analysis
    235
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0347
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 0.55

    Primary: Mean Change in Hemoglobin at Week 5: TP3

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    End point title
    		 Mean Change in Hemoglobin at Week 5: TP3
    End point description
    Mean change in hemoglobin from TP Baseline (defined as the hemoglobin level immediately prior to each treatment course) to Week 5 was non-inferior for ferumoxytol compared to iron sucrose in treatment period 3.
    End point type
    Primary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose Evaluable Population- Ferumoxytol Evaluable Population- Iron Sucrose
    Number of subjects analysed
    130
    64
    124
    58
    Units: gram(s)/decilitre
        arithmetic mean (standard deviation)
    0.6 ( 1.1 )
    0.4 ( 0.87 )
    0.6 ( 1.09 )
    0.5 ( 0.83 )
    Statistical analysis title
    		 LS mean and 95% Confidence Interval for difference
    Comparison groups
    Ferumoxytol v Iron Sucrose
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0592
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.56

    Primary: Mean Change in Hemoglobin at Week 5: TP4

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    End point title
    		 Mean Change in Hemoglobin at Week 5: TP4
    End point description
    Mean change in hemoglobin from TP Baseline (defined as the hemoglobin level immediately prior to each treatment course) to Week 5 was non-inferior for ferumoxytol compared to iron sucrose in treatment period 4.
    End point type
    Primary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose Evaluable Population- Ferumoxytol Evaluable Population- Iron Sucrose
    Number of subjects analysed
    81
    32
    78
    28
    Units: gram(s)/decilitre
        arithmetic mean (standard deviation)
    0.5 ( 1.12 )
    0.6 ( 1.11 )
    0.5 ( 1.13 )
    0.7 ( 1.14 )
    Statistical analysis title
    		 LS mean and 95% Confidence Interval for difference
    Comparison groups
    Ferumoxytol v Iron Sucrose
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.3134
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.63
         upper limit
    		 0.2

    Primary: Mean Change in Hemoglobin at Week 5: TP5

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    End point title
    		 Mean Change in Hemoglobin at Week 5: TP5
    End point description
    Mean change in hemoglobin from TP Baseline (defined as the hemoglobin level immediately prior to each treatment course) to Week 5 was non-inferior for ferumoxytol compared to iron sucrose in treatment period 5.
    End point type
    Primary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose Evaluable Population- Ferumoxytol Evaluable Population- Iron Sucrose
    Number of subjects analysed
    48
    17
    47
    13
    Units: gram(s)/decilitre
        arithmetic mean (standard deviation)
    0.4 ( 1.14 )
    0.3 ( 0.96 )
    0.5 ( 1.15 )
    0.3 ( 0.54 )
    Statistical analysis title
    		 LS mean and 95% Confidence Interval for difference
    Comparison groups
    Ferumoxytol v Iron Sucrose
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.8745
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 0.63

    Primary: Mean Change in Hemoglobin at Week 5: TP6

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    End point title
    		 Mean Change in Hemoglobin at Week 5: TP6
    End point description
    Mean change in hemoglobin from TP Baseline (defined as the hemoglobin level immediately prior to each treatment course) to Week 5 was non-inferior for ferumoxytol compared to iron sucrose in treatment period 6.
    End point type
    Primary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose Evaluable Population- Ferumoxytol Evaluable Population- Iron Sucrose
    Number of subjects analysed
    22
    8
    21
    7
    Units: gram(s)/decilitre
        arithmetic mean (standard deviation)
    0.5 ( 1.21 )
    -0.3 ( 1 )
    0.6 ( 1.23 )
    -0.3 ( 1.07 )
    Statistical analysis title
    		 LS mean and 95% Confidence Interval for difference
    Comparison groups
    Ferumoxytol v Iron Sucrose
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.2253
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 1.69

    Secondary: Mean Change in TSAT at Week 5- TP1

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    End point title
    		 Mean Change in TSAT at Week 5- TP1
    End point description
    Mean change in TSAT from TP Baseline to Week 5 for treatment period 1
    End point type
    Secondary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    195
    95
    Units: percent
        arithmetic mean (standard deviation)
    6.6 ( 9.2 )
    9.5 ( 11.97 )
    No statistical analyses for this end point

    Secondary: Mean Change in TSAT at Week 5- TP2

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    End point title
    		 Mean Change in TSAT at Week 5- TP2
    End point description
    Mean change in TSAT from TP Baseline to Week 5 for treatment period 2
    End point type
    Secondary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    169
    88
    Units: percent
        arithmetic mean (standard deviation)
    8.2 ( 12.95 )
    11.3 ( 14.68 )
    No statistical analyses for this end point

    Secondary: Mean Change in TSAT at Week 5- TP3

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    End point title
    		 Mean Change in TSAT at Week 5- TP3
    End point description
    Mean change in TSAT from TP Baseline to Week 5 for treatment period 3
    End point type
    Secondary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    129
    63
    Units: percent
        arithmetic mean (standard deviation)
    8.5 ( 10.56 )
    9.1 ( 11.13 )
    No statistical analyses for this end point

    Secondary: Mean Change in TSAT at Week 5- TP4

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    End point title
    		 Mean Change in TSAT at Week 5- TP4
    End point description
    Mean change in TSAT from TP Baseline to Week 5 for treatment period 4
    End point type
    Secondary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    80
    32
    Units: percent
        arithmetic mean (standard deviation)
    9.8 ( 14.76 )
    10 ( 14.76 )
    No statistical analyses for this end point

    Secondary: Mean Change in TSAT at Week 5- TP5

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    End point title
    		 Mean Change in TSAT at Week 5- TP5
    End point description
    Mean change in TSAT from TP Baseline to Week 5 for treatment period 5
    End point type
    Secondary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    48
    17
    Units: percent
        arithmetic mean (standard deviation)
    6.3 ( 9.77 )
    14.4 ( 17.05 )
    No statistical analyses for this end point

    Secondary: Mean Change in TSAT at Week 5- TP6

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    End point title
    		 Mean Change in TSAT at Week 5- TP6
    End point description
    Mean change in TSAT from TP Baseline to Week 5 for treatment period 6
    End point type
    Secondary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    21
    8
    Units: percent
        arithmetic mean (standard deviation)
    7.1 ( 16.62 )
    5.1 ( 12.84 )
    No statistical analyses for this end point

    Secondary: Subjects with an increase in hemoglobin of ≥1 g/dL at any time from TP baseline to Week 5- TP1

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    End point title
    		 Subjects with an increase in hemoglobin of ≥1 g/dL at any time from TP baseline to Week 5- TP1
    End point description
    Proportion of subjects with an increase in hemoglobin of ≥1.0 g/dL at any time from TP Baseline to Week 5 for treatment period 1
    End point type
    Secondary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    196
    97
    Units: percent
        number (not applicable)
    28.1
    23.7
    No statistical analyses for this end point

    Secondary: Subjects with an increase in hemoglobin of ≥1 g/dL at any time from TP baseline to Week 5- TP2

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    End point title
    		 Subjects with an increase in hemoglobin of ≥1 g/dL at any time from TP baseline to Week 5- TP2
    End point description
    Proportion of subjects with an increase in hemoglobin of ≥1.0 g/dL at any time from TP Baseline to Week 5 for treatment period 2
    End point type
    Secondary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    173
    88
    Units: percent
        number (not applicable)
    31.8
    14.8
    No statistical analyses for this end point

    Secondary: Subjects with an increase in hemoglobin of ≥1 g/dL at any time from TP baseline to Week 5- TP3

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    End point title
    		 Subjects with an increase in hemoglobin of ≥1 g/dL at any time from TP baseline to Week 5- TP3
    End point description
    Proportion of subjects with an increase in hemoglobin of ≥1.0 g/dL at any time from TP Baseline to Week 5 for treatment period 3
    End point type
    Secondary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    133
    65
    Units: percent
        number (not applicable)
    31.6
    29.2
    No statistical analyses for this end point

    Secondary: Subjects with an increase in hemoglobin of ≥1 g/dL at any time from TP baseline to Week 5- TP4

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    End point title
    		 Subjects with an increase in hemoglobin of ≥1 g/dL at any time from TP baseline to Week 5- TP4
    End point description
    Proportion of subjects with an increase in hemoglobin of ≥1.0 g/dL at any time from TP Baseline to Week 5 for treatment period 4
    End point type
    Secondary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    85
    33
    Units: percent
        number (not applicable)
    23.5
    30.3
    No statistical analyses for this end point

    Secondary: Subjects with an increase in hemoglobin of ≥1 g/dL at any time from TP baseline to Week 5- TP5

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    End point title
    		 Subjects with an increase in hemoglobin of ≥1 g/dL at any time from TP baseline to Week 5- TP5
    End point description
    Proportion of subjects with an increase in hemoglobin of ≥1.0 g/dL at any time from TP Baseline to Week 5 for treatment period 5
    End point type
    Secondary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    49
    18
    Units: percent
        number (not applicable)
    26.5
    16.7
    No statistical analyses for this end point

    Secondary: Subjects with an increase in hemoglobin of ≥1 g/dL at any time from TP baseline to Week 5- TP6

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    End point title
    		 Subjects with an increase in hemoglobin of ≥1 g/dL at any time from TP baseline to Week 5- TP6
    End point description
    Proportion of subjects with an increase in hemoglobin of ≥1.0 g/dL at any time from TP Baseline to Week 5 for treatment period 6
    End point type
    Secondary
    End point timeframe
    Baseline to week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    22
    8
    Units: percent
        number (not applicable)
    22.7
    12.5
    No statistical analyses for this end point

    Secondary: Summary of Treatment-Emergent Adverse Events by Treatment Group

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    End point title
    		 Summary of Treatment-Emergent Adverse Events by Treatment Group
    End point description
    The incidence of treatment-emergent AEs (TEAEs) in various categories by treatment group and in the total study population. A TEAE was defined as an event with an onset date and time on or after the first dosing start date and time, or on or after the first dosing start date if the onset time was missing.
    End point type
    Secondary
    End point timeframe
    on or after the first dosing start date and time
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    196
    97
    Units: number
        All AEs
    158
    81
        Related AEs
    9
    4
        SAEs
    93
    49
        Related SAEs
    0
    0
        AEs of Special Interest protocol defined
    25
    26
        Cardiovascular AEs
    29
    25
        AEs resulting in temp discontinuation of IMP
    2
    3
        AEs resulting in permanent discontinuation of IMP
    8
    0
        AEs resulting in study discontinuation
    20
    7
        Death
    15
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The time a subject signs the informed consent until the last study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    tbc
    Reporting groups
    Reporting group title
    Ferumoxytol
    Reporting group description
    		 -

    Reporting group title
    Iron Sucrose
    Reporting group description
    		 -

    Serious adverse events
    		 Ferumoxytol Iron Sucrose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    93 / 196 (47.45%)
    49 / 97 (50.52%)
         number of deaths (all causes)
    15
    6
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
         subjects affected / exposed
    2 / 196 (1.02%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    12 / 196 (6.12%)
    13 / 97 (13.40%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 14
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    9 / 196 (4.59%)
    6 / 97 (6.19%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Immune system disorders
         subjects affected / exposed
    2 / 196 (1.02%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    21 / 196 (10.71%)
    6 / 97 (6.19%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychiatric disorders
         subjects affected / exposed
    6 / 196 (3.06%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Investigation
         subjects affected / exposed
    0 / 196 (0.00%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Injury, poinsoning and procedural complications
         subjects affected / exposed
    18 / 196 (9.18%)
    16 / 97 (16.49%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 20
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac disorders
    Cardiac disorder
         subjects affected / exposed
    20 / 196 (10.20%)
    15 / 97 (15.46%)
         occurrences causally related to treatment / all
    0 / 31
    0 / 27
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    13 / 196 (6.63%)
    9 / 97 (9.28%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    7 / 196 (3.57%)
    5 / 97 (5.15%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Ear and labyrinth disorders
    Ear and labyrinth disorders
         subjects affected / exposed
    0 / 196 (0.00%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    25 / 196 (12.76%)
    12 / 97 (12.37%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 21
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    1 / 196 (0.51%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    3 / 196 (1.53%)
    3 / 97 (3.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    38 / 196 (19.39%)
    17 / 97 (17.53%)
         occurrences causally related to treatment / all
    0 / 49
    0 / 24
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    17 / 196 (8.67%)
    10 / 97 (10.31%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Ferumoxytol Iron Sucrose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 196 (33.16%)
    48 / 97 (49.48%)
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    26 / 196 (13.27%)
    11 / 97 (11.34%)
         occurrences all number
    63
    24
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    48 / 196 (24.49%)
    15 / 97 (15.46%)
         occurrences all number
    77
    31
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    20 / 196 (10.20%)
    12 / 97 (12.37%)
         occurrences all number
    47
    21
    Psychiatric disorders
    Psychiatric disorders
         subjects affected / exposed
    12 / 196 (6.12%)
    5 / 97 (5.15%)
         occurrences all number
    19
    8
    Investigations
    Investigations
         subjects affected / exposed
    11 / 196 (5.61%)
    11 / 97 (11.34%)
         occurrences all number
    12
    19
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
         subjects affected / exposed
    43 / 196 (21.94%)
    26 / 97 (26.80%)
         occurrences all number
    113
    81
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    10 / 196 (5.10%)
    3 / 97 (3.09%)
         occurrences all number
    33
    6
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    22 / 196 (11.22%)
    15 / 97 (15.46%)
         occurrences all number
    32
    36
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    7 / 196 (3.57%)
    1 / 97 (1.03%)
         occurrences all number
    12
    1
    Gastrointestinal disorders
    Gastrointestinal disorders
         subjects affected / exposed
    49 / 196 (25.00%)
    24 / 97 (24.74%)
         occurrences all number
    131
    64
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    18 / 196 (9.18%)
    9 / 97 (9.28%)
         occurrences all number
    31
    13
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    37 / 196 (18.88%)
    22 / 97 (22.68%)
         occurrences all number
    121
    78
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    26 / 196 (13.27%)
    16 / 97 (16.49%)
         occurrences all number
    63
    37
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    15 / 196 (7.65%)
    5 / 97 (5.15%)
         occurrences all number
    33
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Aug 2014
    Amendment 1 allowed physicians to choose between delivering ferumoxytol as either an IV injection over 1 minute or an IV infusion over a minimum of 15 minutes. Amendment 1 also updated the AE reporting rates with current postmarketing information and changed the collection of prior prescription medications at Screening to the collection of all prior medications at Screening.
    09 Apr 2015
    Amendment 2 required all subjects to receive ferumoxytol as a 15-minute infusion and updated safety information with warnings regarding serious hypersensitivity/anaphylaxis reactions and a new contraindication regarding history of allergy to any IV iron product. The changes were instituted to align the protocol with changes in the Prescribing Information (PI) for ferumoxytol.

    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
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