Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Does ALlopurinol regress lefT ventricular hypertrophy in End stage REnal Disease: The ALTERED study

    Summary
    EudraCT number
    		 2013-001436-22
    Trial protocol
    		 GB  
    Global end of trial date
    30 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Oct 2020
    First version publication date
    18 Oct 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    2012CV07
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01951404
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 British Heart Foundation (Funder) Reference: 29743
    Sponsors
    Sponsor organisation name
    University of Dundee
    Sponsor organisation address
    Ninewells Hospital, Dundee DD1 9SY, Dundee, United Kingdom, DD1 9SY
    Public contact
    Professor Jacob George, University of Dundee, 01382 383656, j.George@dundee.ac.uk
    Scientific contact
    Professor Jacob George, University of Dundee, 01382 383656, j.George@dundee.ac.uk
    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
    30 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study is split into two phases. Phase 1: is a dose finding study. The objective here is to find the minumum dose of allopurinol that will give an average 41% reduction in blood urate levels Phase 2 is the Main Trial. The primary objective here will be to see if Allopurinol can reverse harmful thickening of the heart muscle wall in patients undergoing dialysis.
    Protection of trial subjects
    This study was conducted in accordance with the protocol, International Conference on Harmonisation (ICH) E6 Good Clinical Practice (GCP), the Declaration of Helsinki and all other applicable regulatory requirements. The CI and study staff involved with this study will comply with the requirements of the Data Protection Act 1998 with regard to the collection, storage, processing and disclosure of personal information and will uphold the Act’s core principles. Access to collated participant data will be restricted to those clinicians treating the participants. Computers used to collate the data will have limited access measures via user names and passwords. Published results will not contain any personal data that could allow identification of individual participants.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 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: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    80
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 96 subjects were screened, 80 subjects who fulfilled the eligibility criteria were recruited into the study.

    Pre-assignment
    Screening details
    		 Between January 2014 and June 2015, 96 haemodialysis patients consented to participate in the main ALTERED study. This represented 26% of all approached subjects. Of those who consented, 16 participants were not eligible for randomisation following formal screening, 80 participants were therefore randomised.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Allopurinol
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Allopurinol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100mg, 200mg, 250mg, 300mg or 350mg

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants will be given blinded medication. At the randomisation visit they will be dosed with either allopurinol 100mg or matched placebo. They will then be asked to take one tablet after each dialysis session for two weeks (+/-one dialysis session). Thereafter the medication will be increased weekly as tolerated (+/- 2 days) to the dose decided in the phase 1 dose escalation study – ie one week at 200mg, one week at 250mg, one week at 300mg and up to 350mg, or placebo as determined by pilot data. Compliance will be checked and documented using tablet counts at each visit. If non compliant, they will be encouraged to become compliant. If they persist as non compliant (<70% compliance), they will stay in the study, but not on study medication, in order to do an “intention to treat” analysis.

    Number of subjects in period 1
    		Allopurinol Placebo
    Started
    40
    40
    Completed
    28
    25
    Not completed
    12
    15
         Consent withdrawn by subject
    1
    4
         unknown
    1
    -
         Frailty
    1
    1
         New MRI contraindication
    1
    -
         Death
    2
    5
         Transplanted
    6
    5

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Allopurinol
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Allopurinol Placebo Total
    Number of subjects
    		 40 40 80
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 27 29 56
        From 65-84 years
    		 13 11 24
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.8 ± 11.6 58.0 ± 13.0 -
    Gender categorical
    Units: Subjects
        Female
    		 20 20 40
        Male
    		 20 20 40

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Allopurinol
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: change in LVMI

    		 Close Top of page
    End point title
    		 change in LVMI
    End point description
    End point type
    Primary
    End point timeframe
    12 Months
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: g/m2
        log mean (standard deviation)
    1.6 ± 11.0
    3.6 ± 10.4
    Statistical analysis title
    		 LVMI over 12
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.489
    Method
    		 ANOVA
    Confidence interval

    Secondary: change in LVM

    		 Close Top of page
    End point title
    		 change in LVM
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: g/m2
        log mean (standard deviation)
    2.38 ± 18.82
    6.58 ± 19.01
    Statistical analysis title
    		 change in LVM
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.422
    Method
    		 ANOVA
    Confidence interval

    Secondary: Change in LVEF

    		 Close Top of page
    End point title
    		 Change in LVEF
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: percent
        log mean (standard deviation)
    -1.3 ± 5.6
    -1.0 ± 7.2
    Statistical analysis title
    		 Change in LVEF
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.858
    Method
    		 ANOVA
    Confidence interval

    Secondary: Blood Pressure Pre-dialysis Systolic

    		 Close Top of page
    End point title
    		 Blood Pressure Pre-dialysis Systolic
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: mmHg
        log mean (standard deviation)
    144 ± 28
    141 ± 22
    Statistical analysis title
    		 Blood Pressure
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.626
    Method
    		 ANOVA
    Confidence interval

    Secondary: BP - Pre-dialysis Diastolic

    		 Close Top of page
    End point title
    		 BP - Pre-dialysis Diastolic
    End point description
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: mmHg
        log mean (standard deviation)
    70 ± 15
    72 ± 13
    Statistical analysis title
    		 BP -Pre-dialysis Diastolic
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.547
    Method
    		 ANOVA
    Confidence interval

    Secondary: BP -Post-dialysis Systolic

    		 Close Top of page
    End point title
    		 BP -Post-dialysis Systolic
    End point description
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: mmHg
        log mean (standard deviation)
    131 ± 25
    130 ± 19
    Statistical analysis title
    		 Post-dialysis Systolic
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.772
    Method
    		 ANOVA
    Confidence interval

    Secondary: BP -Post-dialysis Diastolic

    		 Close Top of page
    End point title
    		 BP -Post-dialysis Diastolic
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: mmHg
        log mean (standard deviation)
    66 ± 12
    66 ± 16
    Statistical analysis title
    		 Post-dialysis Diastolic
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.973
    Method
    		 ANOVA
    Confidence interval

    Secondary: Mean 24-hour

    		 Close Top of page
    End point title
    		 Mean 24-hour
    End point description
    End point type
    Secondary
    End point timeframe
    24 hour
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    134 (122 to 148)
    146 (136 to 147)
    Statistical analysis title
    		 Systolic BP
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.73
    Method
    		 ANOVA
    Confidence interval

    Secondary: Mean 24-hour Diastolic BP

    		 Close Top of page
    End point title
    		 Mean 24-hour Diastolic BP
    End point description
    End point type
    Secondary
    End point timeframe
    24 hour
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    70 (59 to 91)
    80 (61 to 95)
    Statistical analysis title
    		 Diastolic BP
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.413
    Method
    		 ANOVA
    Confidence interval

    Secondary: Flow Mediated Dilation (FMD)Change in endothelial dependent flow mediated dilation

    		 Close Top of page
    End point title
    		 Flow Mediated Dilation (FMD)Change in endothelial dependent flow mediated dilation
    End point description
    Change in endothelial dependent flow mediated dilation
    End point type
    Secondary
    End point timeframe
    9 months
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: percent
        log mean (standard deviation)
    0.0 ± 2.9
    -2.6 ± 4.0
    Statistical analysis title
    		 Change in endothelial dependent flow mediated dila
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.124
    Method
    		 ANOVA
    Confidence interval

    Secondary: Flow Mediated Dilation (FMD)Change in endothelial dependent flow mediated dilation

    		 Close Top of page
    End point title
    		 Flow Mediated Dilation (FMD)Change in endothelial dependent flow mediated dilation
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: percent
        median (inter-quartile range (Q1-Q3))
    -0.4 (-2.1 to -0.0)
    1.4 (-3.4 to 5.2)
    Statistical analysis title
    		 Change in endothelial dependent flow mediated dila
    Statistical analysis description
    Change in endothelial dependent flow mediated dilation
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.546
    Method
    		 ANOVA
    Confidence interval

    Secondary: Flow Mediated Dilation (FMD)Change in endothelial independent nitrate mediated dilation

    		 Close Top of page
    End point title
    		 Flow Mediated Dilation (FMD)Change in endothelial independent nitrate mediated dilation
    End point description
    End point type
    Secondary
    End point timeframe
    9 months
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: percent
        log mean (standard deviation)
    -1.5 ± 6.0
    -4.9 ± 4.3
    Statistical analysis title
    		 Flow Mediated Dilation (FMD)
    Statistical analysis description
    Change in endothelial independent nitrate mediated dilation at 9 months
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.193
    Method
    		 ANOVA
    Confidence interval

    Secondary: Flow Mediated Dilation (FMD)Change in endothelial independent nitrate mediated dilation

    		 Close Top of page
    End point title
    		 Flow Mediated Dilation (FMD)Change in endothelial independent nitrate mediated dilation
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: percent
        log mean (standard deviation)
    -2.3 ± 5.2
    -0.4 ± 4.9
    Statistical analysis title
    		 Flow Mediated Dilation (FMD)
    Statistical analysis description
    Change in endothelial independent nitrate mediated dilation at 12 months
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.54
    Method
    		 ANOVA
    Confidence interval

    Secondary: Pulse Wave Analysis (PWA)Change in PWV at 9 months

    		 Close Top of page
    End point title
    		 Pulse Wave Analysis (PWA)Change in PWV at 9 months
    End point description
    End point type
    Secondary
    End point timeframe
    9 months
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: m/s
        log mean (standard deviation)
    0.9 ± 2.7
    0.5 ± 1.8
    Statistical analysis title
    		 Change in PWV at 9 months
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.719
    Method
    		 ANOVA
    Confidence interval

    Secondary: Pulse Wave Analysis (PWA)Change in PWV at 12 months

    		 Close Top of page
    End point title
    		 Pulse Wave Analysis (PWA)Change in PWV at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: m/s
        log mean (standard deviation)
    1.1 ± 1.7
    0.7 ± 2.0
    Statistical analysis title
    		 Pulse Wave Analysis (PWA)
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.718
    Method
    		 ANOVA
    Confidence interval

    Secondary: Change in radial Aix at 12 months

    		 Close Top of page
    End point title
    		 Change in radial Aix at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    12 month
    End point values
    		 Allopurinol Placebo
    Number of subjects analysed
    39
    40
    Units: percent
        log mean (standard deviation)
    -1.4 ± 8.8
    3.6 ± 9.9
    Statistical analysis title
    		 Change in radial Aix at 12 months
    Comparison groups
    Allopurinol v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.255
    Method
    		 ANOVA
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events reported from August 2013 to June 2016
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Randomised Patients
    Reporting group description
    		 -

    Serious adverse events
    		 Randomised Patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 80 (20.00%)
         number of deaths (all causes)
    7
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Arteriovenous fistula site haematoma
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Colectomy
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colectomy total
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal resection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Haematemesis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Intestinal ischaemia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary oedema
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Randomised Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 80 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Intermittent claudication
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Surgical and medical procedures
    Arteriovenous fistula operation
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Arteriovenous graft
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Catheterisation venous
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Enterostomy
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Haemodialysis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Nephrectomy
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Parathyroidectomy
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Tooth extraction
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Vascular catheterisation
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Vascular cauterisation
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Vascular stent insertion
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Catheter site erythema
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Catheter site inflammation
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Catheter site pain
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Catheter site related reaction
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Chest discomfort
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Chest pain
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    9
    Chills
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Complication associated with device
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Feeling cold
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Influenza like illness
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Malaise
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Productive cough
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    5
    Dyspnoea
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Pleural effusion
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Product issues
    Device failure
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Device occlusion
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Thrombosis in device
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    8
    Investigations
    Blood culture positive
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Blood potassium increased
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    2
    Endoscopy upper gastrointestinal tract
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Arteriovenous fistula aneurysm
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences all number
    3
    Arteriovenous fistula maturation failure
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences all number
    3
    Arteriovenous fistula site complication
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences all number
    3
    Arteriovenous fistula site haemorrhage
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    sunburn
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Joint injury
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    fall
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    7
    Limb injury
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Post procedural complication
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Procedural headache
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Procedural vomiting
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Vascular graft complication
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Vascular graft thrombosis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Fistulogram
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences all number
    3
    Gram stain negative
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Imaging procedure
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Liver function test abnormal
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Troponin increased
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Aortic valve thickening
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Atrial fibrillation
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Bradyarrhythmia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Supraventricular tachycardia
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences all number
    5
    Intracardiac thrombus
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Myocardial infarction
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Non STEMI
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Palpitations
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Pericardial effusion
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Pericarditis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Tachyarrhythmia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Aortic valve incompetence
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Hypoaesthesia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Hypoglycaemic unconsciousness
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Neuralgia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Restless legs syndrome
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    5
    Diverticular perforation
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Haematemesis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Intestinal ischaemia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences all number
    3
    Rectal haemorrhage
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    7
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Biliary dilatation
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Rash
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences all number
    3
    skin ulcer
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Costochondritis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Joint swelling
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences all number
    3
    Infections and infestations
    Arteriovenous fistula site infection
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Arthritis infective
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Beta haemolytic streptococcal infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    9
    Viral diarrhoea
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Viral infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    2
    Viral pericarditis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Wound infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Wound infection staphylococcal
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Catheter site infection
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    7
    Cellulitis
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    5
    Device related infection
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    5
    Device related sepsis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Empyema
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    5
    Endocarditis bacterial
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    graft infections
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Hepatic cyst infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Herpes zoster
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Infected fistula
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Infected skin ulcer
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Infection
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Influenza
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    2
    Lower respiratory tract infection
         subjects affected / exposed
    9 / 80 (11.25%)
         occurrences all number
    9
    Nail bed infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Osteomyelitis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Peritonsillar abscess
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    pulmonary sep
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Sepsis
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Staphylococcal infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    9
    Gout
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences all number
    3

    More information

    		 Close Top of page

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 16:09:53 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA