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    Clinical Trial Results:
    The use of Low Molecular Weight Heparin during Hemodiafiltration, A Cross Over Randomised Trial

    Summary
    EudraCT number
    		 2008-005224-91
    Trial protocol
    		 BE  
    Global end of trial date
    15 May 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2008/010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00756145
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    C. Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    HIRUZ CTU, Ghent University Hospital, 32 93320500, HIRUZ.ctu@uzgent.be
    Scientific contact
    HIRUZ CTU, Ghent University Hospital, 32 93320500, HIRUZ.ctu@uzgent.be
    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
    02 Feb 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study was to determine the optimal mode (place and time) of tinzaparin administration during postdilution hemodiafiltration.
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2008
    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
    Belgium: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    3
    From 65 to 84 years
    10
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 22 patients were screened in the period from 18-Sep-2008 till 02-Mar-2010. 14 patients were included and randomized. 1 patient was excluded from the study due to infection. End of trial notification was dated 02-Mar-2010 (last patient last visit) and submitted to EC and CA 24-Jul-2018.

    Pre-assignment
    Screening details
    		 Inclusion criteria -age > 18 years - Chronic kidney disease (CKD) stadium 5 requiring chronic hemodiafiltration of hemodialysis - haematocrit > 30% - signed informed consent

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IN0-OUT0-IN5
    Arm description
    		 Administration of tinzaparin in this arm the first week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0), the second week: administration at the outlet blood line just prior the start of the blood pump (OUT0) the third week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5)
    Arm type
    		 Experimental

    Investigational medicinal product name
    tinzaparin
    Investigational medicinal product code
    Other name
    Innohep, Leo Pharmaceutical Corp, Ballerup, Denmark
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Haemodialysis
    Dosage and administration details
    Tinzaparin with median and interquartile range of 4500 (3500–4500) IU was routinely used. Before the study, tinzaparin was injected in the afferent blood line shortly after the start of the session. The doses had been defined prior to the start of the study, based on the presence or absence of visible clotting of membrane and circuit and/or prolonged bleeding after dialysis.

    Arm title
    		 IN0-IN5-OUT0
    Arm description
    		 Administration of tinzaparin in this arm the first week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0), the second week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5) the third week: administration at the outlet blood line just prior the start of the blood pump (OUT0)
    Arm type
    		 Experimental

    Investigational medicinal product name
    tinzaparin
    Investigational medicinal product code
    Other name
    Innohep, Leo Pharmaceutical Corp, Ballerup, Denmark
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Haemodialysis
    Dosage and administration details
    Tinzaparin with median and interquartile range of 4500 (3500–4500) IU was routinely used. Before the study, tinzaparin was injected in the afferent blood line shortly after the start of the session. The doses had been defined prior to the start of the study, based on the presence or absence of visible clotting of membrane and circuit and/or prolonged bleeding after dialysis.

    Arm title
    		 OUT0-IN5-IN0
    Arm description
    		 Administration of tinzaparin in this arm the first week: administration at the outlet blood line just prior the start of the blood pump (OUT0) the second week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5) the third week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0)
    Arm type
    		 Experimental

    Investigational medicinal product name
    tinzaparin
    Investigational medicinal product code
    Other name
    Innohep, Leo Pharmaceutical Corp, Ballerup, Denmark
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Haemodialysis
    Dosage and administration details
    Tinzaparin with median and interquartile range of 4500 (3500–4500) IU was routinely used. Before the study, tinzaparin was injected in the afferent blood line shortly after the start of the session. The doses had been defined prior to the start of the study, based on the presence or absence of visible clotting of membrane and circuit and/or prolonged bleeding after dialysis.

    Arm title
    		 OUT0-IN0-IN5
    Arm description
    		 Administration of tinzaparin in this arm the first week: administration at the outlet blood line just prior the start of the blood pump (OUT0) the second week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0) the third week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5)
    Arm type
    		 Experimental

    Investigational medicinal product name
    tinzaparin
    Investigational medicinal product code
    Other name
    Innohep, Leo Pharmaceutical Corp, Ballerup, Denmark
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Haemodialysis
    Dosage and administration details
    Tinzaparin with median and interquartile range of 4500 (3500–4500) IU was routinely used. Before the study, tinzaparin was injected in the afferent blood line shortly after the start of the session. The doses had been defined prior to the start of the study, based on the presence or absence of visible clotting of membrane and circuit and/or prolonged bleeding after dialysis.

    Arm title
    		 IN5-IN0-OUT0
    Arm description
    		 Administration of tinzaparin in this arm the first week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5) the second week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0) the third week: administration at the outlet blood line just prior the start of the blood pump (OUT0)
    Arm type
    		 Experimental

    Investigational medicinal product name
    tinzaparin
    Investigational medicinal product code
    Other name
    Innohep, Leo Pharmaceutical Corp, Ballerup, Denmark
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Haemodialysis
    Dosage and administration details
    Tinzaparin with median and interquartile range of 4500 (3500–4500) IU was routinely used. Before the study, tinzaparin was injected in the afferent blood line shortly after the start of the session. The doses had been defined prior to the start of the study, based on the presence or absence of visible clotting of membrane and circuit and/or prolonged bleeding after dialysis.

    Arm title
    		 IN5-OUT0-IN0
    Arm description
    		 Administration of tinzaparin in this arm the first week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5) the second week: administration at the outlet blood line just prior the start of the blood pump (OUT0) the third week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0)
    Arm type
    		 Experimental

    Investigational medicinal product name
    tinzaparin
    Investigational medicinal product code
    Other name
    Innohep, Leo Pharmaceutical Corp, Ballerup, Denmark
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Haemodialysis
    Dosage and administration details
    Tinzaparin with median and interquartile range of 4500 (3500–4500) IU was routinely used. Before the study, tinzaparin was injected in the afferent blood line shortly after the start of the session. The doses had been defined prior to the start of the study, based on the presence or absence of visible clotting of membrane and circuit and/or prolonged bleeding after dialysis.

    Number of subjects in period 1
    		IN0-OUT0-IN5 IN0-IN5-OUT0 OUT0-IN5-IN0 OUT0-IN0-IN5 IN5-IN0-OUT0 IN5-OUT0-IN0
    Started
    2
    3
    1
    3
    3
    2
    Completed
    2
    3
    0
    3
    3
    2
    Not completed
    0
    0
    1
    0
    0
    0
         Adverse event, non-fatal
    -
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 14 14
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 3 3
        From 65-84 years
    		 9 9
        85 years and over
    		 2 2
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 74 (69 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 9 9
    renal diagnosis
    Units: Subjects
        diabetic nephropathy
    		 4 4
        vascular disease
    		 3 3
        kidney disease
    		 2 2
        other
    		 5 5
    body weight
    Units: kg
        median (inter-quartile range (Q1-Q3))
    		 68 (63 to 81.5) -

    End points

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    End points reporting groups
    Reporting group title
    IN0-OUT0-IN5
    Reporting group description
    		 Administration of tinzaparin in this arm the first week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0), the second week: administration at the outlet blood line just prior the start of the blood pump (OUT0) the third week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5)

    Reporting group title
    IN0-IN5-OUT0
    Reporting group description
    		 Administration of tinzaparin in this arm the first week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0), the second week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5) the third week: administration at the outlet blood line just prior the start of the blood pump (OUT0)

    Reporting group title
    OUT0-IN5-IN0
    Reporting group description
    		 Administration of tinzaparin in this arm the first week: administration at the outlet blood line just prior the start of the blood pump (OUT0) the second week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5) the third week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0)

    Reporting group title
    OUT0-IN0-IN5
    Reporting group description
    		 Administration of tinzaparin in this arm the first week: administration at the outlet blood line just prior the start of the blood pump (OUT0) the second week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0) the third week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5)

    Reporting group title
    IN5-IN0-OUT0
    Reporting group description
    		 Administration of tinzaparin in this arm the first week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5) the second week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0) the third week: administration at the outlet blood line just prior the start of the blood pump (OUT0)

    Reporting group title
    IN5-OUT0-IN0
    Reporting group description
    		 Administration of tinzaparin in this arm the first week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5) the second week: administration at the outlet blood line just prior the start of the blood pump (OUT0) the third week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0)

    Subject analysis set title
    IN0
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    analysis of the data of administration of tinzaparin at the inlet blood line just before the start of the blood pump

    Subject analysis set title
    IN5
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    analysis of the data of administration of tinzaparin at the inlet blood line 5 minutes after the detection of blood by the blood detector

    Subject analysis set title
    OUT0
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    analysis of the data of administration of tinzaparin at the outlet blood line just prior the start of the blood pump

    Primary: anti-Xa activity at the end of the session

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    End point title
    		 anti-Xa activity at the end of the session
    End point description
    End point type
    Primary
    End point timeframe
    anti-Xa activity at the end of the heamodiafiltration session
    End point values
    		 IN0 IN5 OUT0
    Number of subjects analysed
    13
    13
    13
    Units: activity
        median (inter-quartile range (Q1-Q3))
    0.14 (0.09 to 0.45)
    0.24 (0.17 to 0.60)
    0.25 (0.15 to 0.64)
    Statistical analysis title
    		 chi square test
    Statistical analysis description
    continuous paired data were analyzed with repeated measures analysis of variance (Friedman) followed by Wilcoxon in case of significance. Chi square test was performed for categorical variables. Correlations were tested with Spearman correlation test.
    Comparison groups
    IN0 v IN5 v OUT0
    Number of subjects included in analysis
    39
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: anti-Xa activity during the session

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    End point title
    		 anti-Xa activity during the session
    End point description
    End point type
    Secondary
    End point timeframe
    Anti-Xa activity measured pre, 30min, 120min and 180min of the heamodiafiltration session
    End point values
    		 IN0 IN5 OUT0
    Number of subjects analysed
    13
    13
    13
    Units: activity
    median (inter-quartile range (Q1-Q3))
        pre
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        30min
    0.95 (0.88 to 1.27)
    1.13 (1.06 to 1.33)
    1.12 (0.89 to 1.37)
        120min
    0.65 (0.46 to 0.97)
    0.77 (0.56 to 0.97)
    0.74 (0.57 to 1.07)
        180min
    0.34 (0.25 to 0.75)
    0.50 (0.34 to 0.78)
    0.47 (0.29 to 0.85)
    Statistical analysis title
    		 chi square test
    Statistical analysis description
    Continuous paired data were analyzed with repeated measures analysis of variance (Friedman) followed by Wilcoxon in case of significance. Chi square test was performed for categorical variables. Correlations were tested with Spearman correlation test.
    Comparison groups
    IN5 v IN0 v OUT0
    Number of subjects included in analysis
    39
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Endogenous Thrombin Potential (ETP)

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    End point title
    		 Endogenous Thrombin Potential (ETP)
    End point description
    End point type
    Secondary
    End point timeframe
    ETP measured pre, 30min, 120min, 180min and 240 min of the heamodiafiltration session
    End point values
    		 IN0 IN5 OUT0
    Number of subjects analysed
    13
    13
    13
    Units: ETP
    median (inter-quartile range (Q1-Q3))
        pre
    0.96 (0.84 to 1.16)
    0.97 (0.88 to 1.12)
    0.97 (0.86 to 1.14)
        30min
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        120min
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        180min
    0 (0 to 0.07)
    0 (0 to 0)
    0 (0 to 0)
        240min
    0.39 (0 to 0.60)
    0.06 (0 to 0.17)
    0.01 (0 to 0.09)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    overall trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    IN0-OUT0-IN5
    Reporting group description
    		 Administration of tinzaparin in this arm the first week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0), the second week: administration at the outlet blood line just prior the start of the blood pump (OUT0) the third week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5)

    Reporting group title
    IN0-IN5-OUT0
    Reporting group description
    		 Administration of tinzaparin in this arm the first week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0), the second week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5) the third week: administration at the outlet blood line just prior the start of the blood pump (OUT0)

    Reporting group title
    OUT0-IN5-IN0
    Reporting group description
    		 Administration of tinzaparin in this arm the first week: administration at the outlet blood line just prior the start of the blood pump (OUT0) the second week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5) the third week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0)

    Reporting group title
    OUT0-IN0-IN5
    Reporting group description
    		 Administration of tinzaparin in this arm the first week: administration at the outlet blood line just prior the start of the blood pump (OUT0) the second week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0) the third week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5)

    Reporting group title
    IN5-IN0-OUT0
    Reporting group description
    		 Administration of tinzaparin in this arm the first week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5) the second week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0) the third week: administration at the outlet blood line just prior the start of the blood pump (OUT0)

    Reporting group title
    IN5-OUT0-IN0
    Reporting group description
    		 Administration of tinzaparin in this arm the first week: administration at inlet blood line 5 minutes after the detection of blood by the blood detector (IN5) the second week: administration at the outlet blood line just prior the start of the blood pump (OUT0) the third week: administration of tinzaparin at the inlet blood line just before the start of the blood pump (IN0)

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events were found for these results
    Serious adverse events
    		 IN0-OUT0-IN5 IN0-IN5-OUT0 OUT0-IN5-IN0 OUT0-IN0-IN5 IN5-IN0-OUT0 IN5-OUT0-IN0
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IN0-OUT0-IN5 IN0-IN5-OUT0 OUT0-IN5-IN0 OUT0-IN0-IN5 IN5-IN0-OUT0 IN5-OUT0-IN0
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)

    More information

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

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

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26076014
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