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    Clinical Trial Results:
    Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects with Chronic Kidney Disease

    Summary
    EudraCT number
    		 2009-015630-30
    Trial protocol
    		 BE   DE   GB  
    Global end of trial date
    19 Jul 2011

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

    Trial information

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    Trial identification
    Sponsor protocol code
    FER-CKD-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01052779
    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
    19 Apr 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).
    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
    01 Mar 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 21
    Country: Number of subjects enrolled
    United States: 97
    Country: Number of subjects enrolled
    Poland: 20
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Belgium: 11
    Country: Number of subjects enrolled
    Germany: 7
    Worldwide total number of subjects
    162
    EEA total number of subjects
    44
    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)
    82
    From 65 to 84 years
    75
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 There was a 2-week Screening Period (Day -14 to -1).

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    None (Open Label)

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ferumoxytol
    Arm description
    		 Participants received an IV injection of ferumoxytol (510 milligrams [mg], 17 milliliters [mL]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ferumoxytol
    Investigational medicinal product code
    Other name
    Feraheme
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Each 20 mL single-use vial contained 17 mL of ferumoxytol that consisted of iron at a concentration of 30 mg Fe/mL, and mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution. Both hemodialysis and nondialysis participants received 2 IV injections of ferumoxytol 510 mg (17 mL), the first on Day 1 and the second 5±3 days later, for a total cumulative dose of 1.02 g.

    Arm title
    		 Iron Sucrose
    Arm description
    		 Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Iron Sucrose
    Investigational medicinal product code
    Other name
    Venofer
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Each mL contained 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contained 100 mg of iron per 5 mL. The drug product contained approximately 30% sucrose (300 mg/mL). The product contained no preservatives. Participants received iron sucrose as a slow IV injection or IV infusion based on dialysis status: • Hemodialysis participants received 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. • Nondialysis participants received 200 mg iron sucrose at Day 1 and at 4 other nonconsecutive visits over a 14-day (±2 days) period for a total cumulative dose of 1.0 g.

    Number of subjects in period 1
    		Ferumoxytol Iron Sucrose
    Started
    80
    82
    Received at Least 1 Dose of Study Drug
    80
    81
    Completed
    75
    73
    Not completed
    5
    9
         Other-Surgery
    -
    2
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    1
    4
         Other-Protocol Violation
    1
    1
         Other-Missed Week 5 Visit
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ferumoxytol
    Reporting group description
    		 Participants received an IV injection of ferumoxytol (510 milligrams [mg], 17 milliliters [mL]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).

    Reporting group title
    Iron Sucrose
    Reporting group description
    		 Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.

    Reporting group values
    		 Ferumoxytol Iron Sucrose Total
    Number of subjects
    		 80 82 162
    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)
    		 39 43 82
        From 65-84 years
    		 39 36 75
        85 years and over
    		 2 3 5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.9 ± 15.00 63.3 ± 15.16 -
    Gender categorical
    Units: Subjects
        Female
    		 41 39 80
        Male
    		 39 43 82
    Dialysis Status
    Units: Subjects
        Hemodialysis
    		 34 36 70
        Nondialysis
    		 46 46 92

    End points

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    End points reporting groups
    Reporting group title
    Ferumoxytol
    Reporting group description
    		 Participants received an IV injection of ferumoxytol (510 milligrams [mg], 17 milliliters [mL]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).

    Reporting group title
    Iron Sucrose
    Reporting group description
    		 Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.

    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 (IV ferumoxytol or IV iron sucrose).

    Primary: Mean Change In Hemoglobin From Baseline (Day 1) To Week 5

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    End point title
    		 Mean Change In Hemoglobin From Baseline (Day 1) To Week 5
    End point description
    The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) – Hemoglobin (Baseline) The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were performed without imputation for missing data and with the Markov chain Monte Carlo method.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1), Week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    80 [1]
    82 [2]
    Units: g/dL
    least squares mean (standard error)
        With LOCF Imputation
    0.84 ± 0.14
    0.74 ± 0.14
        Without Imputation (Sensitivity Analysis)
    0.89 ± 0.15
    0.80 ± 0.15
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    		 Analysis 1 For Mean Change In Hemoglobin
    Statistical analysis description
    With LOCF Imputation: The p-value and two-sided 95% confidence interval (CI) for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an analysis of variance (ANOVA) model adjusted for baseline hemoglobin level and hemodialysis status.
    Comparison groups
    Ferumoxytol v Iron Sucrose
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 = 0.515 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Treatment Difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.21
         upper limit
    		 0.41
    Notes
    [3] - Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.
    [4] - The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.
    Statistical analysis title
    		 Analysis 2 For Mean Change In Hemoglobin
    Statistical analysis description
    Without Imputation (Sensitivity Analysis): The p-value and two-sided 95% CI for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an ANOVA model adjusted for baseline hemoglobin level and hemodialysis status.
    Comparison groups
    Ferumoxytol v Iron Sucrose
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    P-value
    		 = 0.587 [6]
    Method
    		 ANCOVA
    Parameter type
    		 Treatment Difference
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 0.41
    Notes
    [5] - Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.
    [6] - The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.

    Primary: Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5

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    End point title
    		 Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5 [7]
    End point description
    The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug).
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and up to Week 5
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Quantitative statistical analysis (for example, a p-value) was not performed for this endpoint. Only descriptive statistics are included (percentage).
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    80 [8]
    82 [9]
    Units: percent
    number (not applicable)
        Week 2
    25
    13.41
        Week 3
    40
    24.39
        Week 4
    46.25
    37.80
        Week 5
    50
    41.46
    Notes
    [8] - ITT Population
    [9] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The period during which adverse events were reported was defined from the time a participant signed the informed consent until the last study visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Ferumoxytol
    Reporting group description
    		 Participants received an IV injection of ferumoxytol (510 milligrams [mg], 17 milliliters [mL]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).

    Reporting group title
    Iron Sucrose
    Reporting group description
    		 Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.

    Serious adverse events
    		 Ferumoxytol Iron Sucrose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 80 (8.75%)
    6 / 82 (7.32%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anastomotic haemorrhage
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft thrombosis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         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 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal adhesions
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (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 prerenal failure
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure chronic
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous graft site infection
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Ferumoxytol Iron Sucrose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 80 (43.75%)
    50 / 82 (60.98%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Hot flush
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 82 (1.22%)
         occurrences all number
    1
    1
    Hypotension
         subjects affected / exposed
    2 / 80 (2.50%)
    8 / 82 (9.76%)
         occurrences all number
    3
    17
    Poor venous access
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Catheter site erythema
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Device leakage
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    2 / 80 (2.50%)
    6 / 82 (7.32%)
         occurrences all number
    2
    6
    Fatigue
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Feeling cold
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Feeling hot
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 82 (1.22%)
         occurrences all number
    1
    1
    Injection site haematoma
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Injection site haemorrhage
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Injection site pain
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 82 (2.44%)
         occurrences all number
    1
    2
    Medical device complication
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Tenderness
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Thrombosis in device
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Social circumstances
    Treatment noncompliance
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    3 / 80 (3.75%)
    0 / 82 (0.00%)
         occurrences all number
    3
    0
    Dyspnoea
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Rales
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Investigations
    Blood glucose increased
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    2
    Breath sounds abnormal
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Cardiac murmur
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Weight increased
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Burns first degree
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Humerus fracture
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Procedural hypertension
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Procedural hypotension
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    7
    0
    Scratch
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Sunburn
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Vascular graft thrombosis
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 82 (2.44%)
         occurrences all number
    1
    2
    Dysgeusia
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 82 (1.22%)
         occurrences all number
    1
    1
    Facial palsy
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 82 (1.22%)
         occurrences all number
    1
    1
    Headache
         subjects affected / exposed
    3 / 80 (3.75%)
    2 / 82 (2.44%)
         occurrences all number
    3
    2
    Paraesthesia
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 82 (1.22%)
         occurrences all number
    1
    1
    Parosmia
         subjects affected / exposed
    0 / 80 (0.00%)
    4 / 82 (4.88%)
         occurrences all number
    0
    31
    Unresponsive to stimuli
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Anaemia
         subjects affected / exposed
    2 / 80 (2.50%)
    1 / 82 (1.22%)
         occurrences all number
    2
    1
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    2 / 80 (2.50%)
    3 / 82 (3.66%)
         occurrences all number
    2
    3
    Diarrhoea
         subjects affected / exposed
    2 / 80 (2.50%)
    1 / 82 (1.22%)
         occurrences all number
    2
    2
    Nausea
         subjects affected / exposed
    6 / 80 (7.50%)
    3 / 82 (3.66%)
         occurrences all number
    6
    3
    Tooth disorder
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 82 (2.44%)
         occurrences all number
    1
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Cold sweat
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Ecchymosis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Ingrowing nail
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Skin haemorrhage
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Nocturia
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Bone pain
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Flank pain
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 82 (1.22%)
         occurrences all number
    1
    1
    Limb discomfort
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    4 / 80 (5.00%)
    6 / 82 (7.32%)
         occurrences all number
    4
    12
    Myalgia
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 82 (2.44%)
         occurrences all number
    0
    2
    Neck pain
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 82 (2.44%)
         occurrences all number
    1
    2
    Synovial cyst
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 80 (3.75%)
    2 / 82 (2.44%)
         occurrences all number
    3
    2
    Sinusitis
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Staphylococcal abscess
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 82 (0.00%)
         occurrences all number
    1
    0
    Urethritis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    3 / 80 (3.75%)
    5 / 82 (6.10%)
         occurrences all number
    4
    6
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 80 (1.25%)
    3 / 82 (3.66%)
         occurrences all number
    1
    3
    Hyperglycaemia
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 82 (1.22%)
         occurrences all number
    1
    1
    Hyperkalaemia
         subjects affected / exposed
    3 / 80 (3.75%)
    0 / 82 (0.00%)
         occurrences all number
    3
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    2 / 80 (2.50%)
    3 / 82 (3.66%)
         occurrences all number
    2
    4
    Vitamin D deficiency
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 82 (1.22%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jan 2010
    • To ensure participant safety as well as comply with all the label requirements across countries, additional information regarding the adequate medical care needed to treat those participants who may experience a hypersensitivity reaction following administration of study drug has been added. • Bicarbonate and magnesium have been added to the list of serum chemistry analytes.
    01 Nov 2010
    • To examine the effects of ferumoxytol and iron sucrose on biomarkers of oxidative stress and tubular damage, an optional substudy has been added. This substudy will require participating participants to give additional blood samples (between 5 and 7 draws) of 8 mL each, before and after study drug administration. Since the addition of this substudy will require no change to the inclusion/exclusion criteria or to the conduct of the main study, the integrity of FER-CKD-201 will be maintained. Participants who choose to enroll in the substudy will sign an additional consent form. • The protocol has been updated to provide clarification regarding the timing of vital signs (measured from initiation of dosing) and the timing around the collection of adverse events (60 minutes from completion of dosing). These two changes were already captured in an administrative letter.

    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/27462400
    http://www.ncbi.nlm.nih.gov/pubmed/24458078
    For support, Contact us.
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