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    Clinical Trial Results:
    An Open-Label Study to Investigate the Efficacy and Safety of Peginesatide in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients With Chronic Kidney Disease.

    Summary
    EudraCT number
    		 2005-004944-30
    Trial protocol
    		 GB   DE  
    Global end of trial date
    31 Oct 2016

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 May 2019
    First version publication date
    08 Nov 2017
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Additional information.

    Trial information

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    Trial identification
    Sponsor protocol code
    AFX01-06
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00314795
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Takeda Development Centre Europe Ltd
    Sponsor organisation address
    61 Aldwych, London, United Kingdom, WC2B 4AE
    Public contact
    Medical Director, Clinical Science, Takeda, +1 877-825-3327, clinicaltrialregistry@tpna.com
    Scientific contact
    Medical Director, Clinical Science, Takeda, +1 877-825-3327, clinicaltrialregistry@tpna.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
    31 Oct 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the ability of peginesatide (AF37702) to increase and maintain increased hemoglobin levels in participants with chronic kidney disease (CKD) (either not on dialysis, receiving regular hemodialysis or peritoneal dialysis, or following renal transplant) with confirmed antibody-mediated pure red cell aplasia (PRCA).
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Apr 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 6 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    United Kingdom: 8
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    6
    From 65 to 84 years
    12
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 5 investigative sites in Europe from 06-Apr-2006 to 31-Oct-2016.

    Pre-assignment
    Screening details
    		 Participants with a diagnosis of chronic renal failure (CRF) with confirmed antibody-mediated pure red cell aplasia (PRCA) were enrolled to receive peginesatide subcutaneous injection up to 0.3 mg/kg, once every 4 weeks for up to 60 months.

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

    Arms
    Arm title
    		 Peginesatide
    Arm description
    		 Peginesatide 0.05 mg/kg injection, subcutaneously followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 60 months. Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0–12.0 g/dL.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Peginesatide
    Investigational medicinal product code
    Other name
    AF37702
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    Peginesatide injection

    Number of subjects in period 1
    		Peginesatide
    Started
    22
    Completed
    2
    Not completed
    20
         Adverse event, serious fatal
    4
         Renal Transplant
    3
         Adverse event, non-fatal
    8
         Participants Withdrew Consent
    2
         Reason not Specified
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Peginesatide
    Reporting group description
    		 Peginesatide 0.05 mg/kg injection, subcutaneously followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 60 months. Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0–12.0 g/dL.

    Reporting group values
    		 Peginesatide Total
    Number of subjects
    		 22 22
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 73.3 ( 13.65 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 5 5
        Male
    		 17 17
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 4 4
        Caucasian
    		 17 17
        Other
    		 1 1
    Bone Marrow Evaluation
    Here Erythroblastopenia=EBP; Hypoplasia= HYP; Hypocellular=hpc; bone marrow=BM; Erythroid lineage-EL; diagnosis=dgn; reticulocyte=retic.
    Units: Subjects
        Aplasia of Erythropoese
    		 1 1
        Erythroblastopenia (EBP)
    		 1 1
        EBP 0% normal values for other cell lineages
    		 1 1
        Erythroid series absent
    		 1 1
        Erythroid severe HYP no decrease in other lineages
    		 1 1
        Erythropoietic hypoplasia
    		 1 1
        Hpc BM with reduced EL consistent with dgn of pure
    		 1 1
        HYP of erythropoiesis staining of iron in BM retic
    		 1 1
        Normal
    		 1 1
        PRCA
    		 8 8
        PRCA / Bone Marrow Trephine
    		 1 1
        Pure Red Cell Aplasia
    		 2 2
        Red cell aplasia
    		 1 1
        Red cell hypoplasia
    		 1 1
    Region of Enrollment
    Units: Subjects
        France
    		 6 6
        Germany
    		 8 8
        United Kingdom
    		 8 8
    Study Specific Characteristic | Height
    Data was available for 21 participants.
    Units: cm
        arithmetic mean (standard deviation)
    		 ( ) -
    Study Specific Characteristic | Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 67.6 ( 12.31 ) -
    Study Specific Characteristic | Body Mass Index (BMI)
    Data was available for 21 participants.
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 ( ) -
    Study Specific Characteristic | Baseline Hemoglobin (Hgb)
    Units: g/L
        arithmetic mean (standard deviation)
    		 96.5 ( 16.11 ) -
    Study Specific Characteristic | Baseline Ferritin
    Data was available for 21 participants.
    Units: ug/L
        arithmetic mean (standard deviation)
    		 ( ) -
    Study Specific Characteristic | Baseline Transferrin Saturation
    Data was available for 19 participants.
    Units: % transferrin
        arithmetic mean (standard deviation)
    		 ( ) -
    Study Specific Characteristic | Baseline Anti-erythropoietin (EPO) Antibody Titers
    Units: U/mL
        arithmetic mean (standard deviation)
    		 94.1 ( 217.08 ) -
    Subject analysis sets

    Subject analysis set title
    Peginesatide
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Peginesatide 0.05 mg/kg injection, subcutaneously followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 60 months. Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0–12.0 g/dL.

    Subject analysis set title
    Peginesatide
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Peginesatide 0.05 mg/kg injection, subcutaneously followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 60 months. Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0–12.0 g/dL.

    Subject analysis sets values
    		 Peginesatide Peginesatide
    Number of subjects
    21
    19
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender, Male/Female
    Units: Subjects
        Female
        Male
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
        Caucasian
        Other
    Bone Marrow Evaluation
    Here Erythroblastopenia=EBP; Hypoplasia= HYP; Hypocellular=hpc; bone marrow=BM; Erythroid lineage-EL; diagnosis=dgn; reticulocyte=retic.
    Units: Subjects
        Aplasia of Erythropoese
        Erythroblastopenia (EBP)
        EBP 0% normal values for other cell lineages
        Erythroid series absent
        Erythroid severe HYP no decrease in other lineages
        Erythropoietic hypoplasia
        Hpc BM with reduced EL consistent with dgn of pure
        HYP of erythropoiesis staining of iron in BM retic
        Normal
        PRCA
        PRCA / Bone Marrow Trephine
        Pure Red Cell Aplasia
        Red cell aplasia
        Red cell hypoplasia
    Region of Enrollment
    Units: Subjects
        France
        Germany
        United Kingdom
    Study Specific Characteristic | Height
    Data was available for 21 participants.
    Units: cm
        arithmetic mean (standard deviation)
    168.1 ( 9.66 )
    ( )
    Study Specific Characteristic | Weight
    Units: kg
        arithmetic mean (standard deviation)
    ( )
    ( )
    Study Specific Characteristic | Body Mass Index (BMI)
    Data was available for 21 participants.
    Units: kg/m^2
        arithmetic mean (standard deviation)
    23.8 ( 2.41 )
    ( )
    Study Specific Characteristic | Baseline Hemoglobin (Hgb)
    Units: g/L
        arithmetic mean (standard deviation)
    ( )
    ( )
    Study Specific Characteristic | Baseline Ferritin
    Data was available for 21 participants.
    Units: ug/L
        arithmetic mean (standard deviation)
    2332.0 ( 1695.02 )
    ( )
    Study Specific Characteristic | Baseline Transferrin Saturation
    Data was available for 19 participants.
    Units: % transferrin
        arithmetic mean (standard deviation)
    ( )
    79.2 ( 21.87 )
    Study Specific Characteristic | Baseline Anti-erythropoietin (EPO) Antibody Titers
    Units: U/mL
        arithmetic mean (standard deviation)
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    Peginesatide
    Reporting group description
    		 Peginesatide 0.05 mg/kg injection, subcutaneously followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 60 months. Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0–12.0 g/dL.

    Subject analysis set title
    Peginesatide
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Peginesatide 0.05 mg/kg injection, subcutaneously followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 60 months. Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0–12.0 g/dL.

    Subject analysis set title
    Peginesatide
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Peginesatide 0.05 mg/kg injection, subcutaneously followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 60 months. Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0–12.0 g/dL.

    Primary: Percentage of Participants who Experienced Increase and Maintain Hemoglobin Levels (two consecutive values) Greater Than or Equal to the Lower Limit of the Target Range in the Absence of Red Blood Cell Transfusion in the Previous 28 days by Week 24

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    End point title
    		 Percentage of Participants who Experienced Increase and Maintain Hemoglobin Levels (two consecutive values) Greater Than or Equal to the Lower Limit of the Target Range in the Absence of Red Blood Cell Transfusion in the Previous 28 days by Week 24 [1]
    End point description
    Percentage of participants who experienced increase and maintain hemoglobin levels (two consecutive values) greater than or equal to the lower limit (11 g/dL) in the absence of red blood cell transfusion in the previous 28 days by week 24 were reported.
    End point type
    Primary
    End point timeframe
    Up to Week 24
    Notes
    [1] - 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: Statistical analysis was not performed for this endpoint.
    End point values
    		 Peginesatide
    Number of subjects analysed
    0 [2]
    Units: percentage of participants
        number (confidence interval 95%)
    ( to )
    Notes
    [2] - Data was not collected due to low subject enrollment and the drug was withdrawn from the market.
    No statistical analyses for this end point

    Secondary: Number of Red Blood Cells (RBCs) Transfusions During the 26 Weeks Pre-treatment Period (prior to enrollment) and During 13- and 26 Weeks Intervals During the Study

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    End point title
    		 Number of Red Blood Cells (RBCs) Transfusions During the 26 Weeks Pre-treatment Period (prior to enrollment) and During 13- and 26 Weeks Intervals During the Study
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks prior to enrollment up to end of study (up to 60 months)
    End point values
    		 Peginesatide
    Number of subjects analysed
    0 [3]
    Units: RBCs transfusion
    Notes
    [3] - Data was not collected due to low subject enrollment and the drug was withdrawn from the market.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with RBC Transfusions During the 26-week Pre-treatment Period and During 13- and 26-week Intervals During the Study

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    End point title
    		 Percentage of Participants with RBC Transfusions During the 26-week Pre-treatment Period and During 13- and 26-week Intervals During the Study
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks prior to enrollment up to end of study (up to 60 months)
    End point values
    		 Peginesatide
    Number of subjects analysed
    0 [4]
    Units: percentage of participants
        number (confidence interval 95%)
    ( to )
    Notes
    [4] - Data was not collected due to low subject enrollment and the drug was withdrawn from the market.
    No statistical analyses for this end point

    Secondary: Time to Initial Achievement of Hemoglobin (Hgb) Greater Than or Equal to the Lower Limit of the Target Range in the Absence of Red Blood Cell Transfusions in the Previous 28 Days

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    End point title
    		 Time to Initial Achievement of Hemoglobin (Hgb) Greater Than or Equal to the Lower Limit of the Target Range in the Absence of Red Blood Cell Transfusions in the Previous 28 Days
    End point description
    The time between first dose administered and the initial achievement of a Hgb increase ≥11 g/dL for two consecutive visits was calculated for each participant as the number of days between the first dose administration date and the earlier of (1) the study termination date [i.e. censor date] and (2) the first date of an Hgb increase ≥ 11 g/dL for two consecutive visits without whole blood or RBC transfusion during the previous 28 days. Time to initial Hgb increase ≥ 11 g/dL will be calculated for each participant as the minimum of censor date and increase date minus the first dose date plus 1.
    End point type
    Secondary
    End point timeframe
    Up to 60 months
    End point values
    		 Peginesatide
    Number of subjects analysed
    0 [5]
    Units: days
        median (full range (min-max))
    ( to )
    Notes
    [5] - Data was not collected due to low subject enrollment and the drug was withdrawn from the market.
    No statistical analyses for this end point

    Secondary: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation

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    End point title
    		 Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation
    End point description
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Safety analysis set included all participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    From signing of informed consent form up to Month 60
    End point values
    		 Peginesatide
    Number of subjects analysed
    22
    Units: participants
        AEs
    22
        SAEs
    17
        AEs Leading to Study Drug Discontinuation
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing of informed consent form up to Month 60
    Adverse event reporting additional description
    At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Peginesatide
    Reporting group description
    		 Peginesatide 0.05 mg/kg injection, subcutaneously followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 60 months. Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0–12.0 g/dL.

    Serious adverse events
    		 Peginesatide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 22 (77.27%)
         number of deaths (all causes)
    9
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastrointestinal cancer metastatic
    Additional description: One treatment emergent death occurred and is related to the study drug.
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Metastases to bone
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood pressure inadequately controlled
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femoral artery aneurysm
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Death
    Additional description: Treatment-emergent death is not related to the study drug.
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Sudden death
    Additional description: Treatment-emergent death is not related to the study drug.
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Vascular stent restenosis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
    Additional description: One treatment-emergent death occurred and is not related to the study drug.
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Drug specific antibody present
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematocrit decreased
    Additional description: One treatment-emergent death occurred and is not related to the study drug.
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritoneal dialysis complication
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Shunt occlusion
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
    Additional description: One treatment-emergent death occurred and is not related to the study drug.
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Cardiac failure
    Additional description: One treatment-emergent death occurred and is not related to the study drug.
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Cardiac failure acute
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Vascular dementia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Optic ischaemic neuropathy
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Anal prolapse
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
    Additional description: One treatment-emergent death occurred and is not related to the study drug.
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Renal and urinary disorders
    Renal salt-wasting syndrome
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Disseminated tuberculosis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gangrene
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
    Additional description: One treatment-emergent death occurred and is not related to the study drug.
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Urosepsis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Fluid overload
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Peginesatide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 22 (100.00%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    3
    Hypertension
         subjects affected / exposed
    6 / 22 (27.27%)
         occurrences all number
    14
    Hypotension
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 22 (22.73%)
         occurrences all number
    9
    Oedema peripheral
         subjects affected / exposed
    7 / 22 (31.82%)
         occurrences all number
    10
    Asthenia
         subjects affected / exposed
    6 / 22 (27.27%)
         occurrences all number
    7
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Pyrexia
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    3
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    5
    Seasonal allergy
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 22 (22.73%)
         occurrences all number
    7
    Dyspnoea
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    5
    Rales
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    5
    Oropharyngeal pain
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Pleural effusion
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    6 / 22 (27.27%)
         occurrences all number
    11
    Weight decreased
         subjects affected / exposed
    4 / 22 (18.18%)
         occurrences all number
    4
    Blood pressure increased
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    5
    Blood phosphorus increased
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Blood potassium increased
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Liver function test increased
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Platelet count decreased
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    3
    Reticulocyte count decreased
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    4
    Injury, poisoning and procedural complications
    Skin abrasion
         subjects affected / exposed
    5 / 22 (22.73%)
         occurrences all number
    8
    Fall
         subjects affected / exposed
    8 / 22 (36.36%)
         occurrences all number
    9
    Contusion
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    9
    Procedural hypotension
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    3
    Heat exhaustion
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    5
    Restless legs syndrome
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    3
    Sciatica
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Eye disorders
    Cataract
         subjects affected / exposed
    4 / 22 (18.18%)
         occurrences all number
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 22 (45.45%)
         occurrences all number
    11
    Constipation
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    5
    Toothache
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    4
    Nausea
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    3
    Vomiting
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    4
    Hepatobiliary disorders
    Hepatomegaly
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    4 / 22 (18.18%)
         occurrences all number
    4
    Pruritus Generalised
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    3
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    4 / 22 (18.18%)
         occurrences all number
    4
    Chronic kidney disease
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 22 (22.73%)
         occurrences all number
    6
    Muscle spasms
         subjects affected / exposed
    5 / 22 (22.73%)
         occurrences all number
    5
    Back pain
         subjects affected / exposed
    5 / 22 (22.73%)
         occurrences all number
    6
    Musculoskeletal pain
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Osteoarthritis
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    6 / 22 (27.27%)
         occurrences all number
    9
    Nasopharyngitis
         subjects affected / exposed
    10 / 22 (45.45%)
         occurrences all number
    20
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    4
    Urinary tract infection
         subjects affected / exposed
    6 / 22 (27.27%)
         occurrences all number
    14
    Cystitis
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    3
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Respiratory tract infection
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 22 (18.18%)
         occurrences all number
    4
    Fluid overload
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jul 2006
    Changed the study design for starting dose, dose escalation, maximum dose, and dose reduction criteria, extended dosing from 6 months to 24 months and updated inclusion criteria.
    15 Nov 2007
    Increased continuation of treatment duration to up to 60 months and revised individual patient peginesatide dose adjustment guidelines due to safety concerns associated with elevated haemoglobin (Hgb) values on erythropoiesis-stimulating agent use.
    07 Jun 2010
    Increased continuation of treatment duration to up to 70 months.
    15 Apr 2011
    Changed study design for starting dose, maximum dose, and Hgb target range, provided details for study endpoints and increased continuation of treatment duration to up to 108 months.
    23 Apr 2013
    Sponsor changed from Affymax to Takeda
    04 Apr 2014
    Extended continuation of treatment duration to 30 September 2015 and added vials with concentration of 6 mg/0.5 ml.
    09 Jul 2014
    Changed frequency of sample collection for peginesatide-specific and anti-erythropoietin antibodies.
    16 Jun 2015
    Extended continuation of treatment duration to approximately 30 September 2016.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Feb 2013
    Following post-marketing reports of serious hypersensitivity reactions, enrolment of new subjects into the study was halted (due to risk of hypersensitivity after first injection) and subjects already in the study were informed and reconsented, (ie, were given the option to stop or continue treatment), so study treatment was not halted (subjects with PRCA in the study had been receiving treatment for between approximately 1 and up to 7 years and their benefit:risk remained positive).
    -

    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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