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    Clinical Trial Results:
    Effects of mannitol on delayed graft function after cadaveric renal transplantation

    Summary
    EudraCT number
    		 2014-005391-29
    Trial protocol
    		 AT  
    Global end of trial date
    01 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2021
    First version publication date
    14 May 2021
    Other versions
    Summary report(s)
    		 Mannitol_BMC

    Trial information

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    Trial identification
    Sponsor protocol code
    2021/2014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02705573
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria,
    Public contact
    Head Office, Medical University of Vienna, 0043 14040041020, sekretariat-anaesthesie@meduniwien.ac.at
    Scientific contact
    Head Office, Medical University of Vienna, 0043 14040041020, sekretariat-anaesthesie@meduniwien.ac.at
    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
    12 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Effects of mannitol on delayed graft function after cadaveric renal transplantation
    Protection of trial subjects
    Blinded follow-up within 24 hours after surgery
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jan 2018
    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
    Austria: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    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)
    24
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: January 2018 and July 2018; Recruitment territories: Austria

    Pre-assignment
    Screening details
    		 Patients with end-stage renal disease between 18 and 80 years of age undergoing deceased donor renal transplantation were eligible. Exclusion criterion was a known allergy to mannitol.

    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
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    IMP was prepared and blinded by the hospital pharmacy "Bad Ischl".

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mannitol
    Arm description
    		 Patients assigned to this group received a solution of 20% mannitol after reperfusion of the graft.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mannitol 20% or NaCl 0-9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    20% mannitol solution (blinded) Dosage: 5mL/KG Administration: 100ml of 20% study medication were given as bolus after reperfusion of the graft, the remaining infusion was given until end of surgery

    Arm title
    		 NaCl
    Arm description
    		 Patients assigned to this group recieved 0.9% NaCl solution after reperfusion of the graft.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Mannitol 20% or NaCl 0-9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.9% NaCL (blinded) Dosage: 5mL/KG Administration: 100ml of study solution were given as bolus after reperfusion of the graft, the remaining infusion was given until end of surgery

    Number of subjects in period 1
    		Mannitol NaCl
    Started
    17
    17
    Completed
    16
    16
    Not completed
    1
    1
         Adverse event, serious fatal
    1
    -
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mannitol
    Reporting group description
    		 Patients assigned to this group received a solution of 20% mannitol after reperfusion of the graft.

    Reporting group title
    NaCl
    Reporting group description
    		 Patients assigned to this group recieved 0.9% NaCl solution after reperfusion of the graft.

    Reporting group values
    		 Mannitol NaCl Total
    Number of subjects
    		 17 17 34
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 10 14 24
        From 65-84 years
    		 7 3 10
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 62 (57 to 71) 53 (45 to 68) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7 14
        Male
    		 10 10 20

    End points

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    End points reporting groups
    Reporting group title
    Mannitol
    Reporting group description
    		 Patients assigned to this group received a solution of 20% mannitol after reperfusion of the graft.

    Reporting group title
    NaCl
    Reporting group description
    		 Patients assigned to this group recieved 0.9% NaCl solution after reperfusion of the graft.

    Primary: Differences in a set of biomarkers

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    End point title
    		 Differences in a set of biomarkers
    End point description
    End point type
    Primary
    End point timeframe
    within 24 hours after graft reperfusion
    End point values
    		 Mannitol NaCl
    Number of subjects analysed
    16 [1]
    16 [2]
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    3492 (3040 to 4910)
    3828 (3299 to 6556)
    Notes
    [1] - 1 patient died within the study period
    [2] - loss of follow up in 1 patient
    Statistical analysis title
    		 Mixed Linear Model for biomarker concentrations
    Comparison groups
    Mannitol v NaCl
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Within 24 hours after renal graft reperfussion
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Mannitol administration

    Reporting group title
    Arm 2
    Reporting group description
    		 Placebo administration

    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: 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. Either resolve this issue or provide a justification.
    Serious adverse events
    		 Arm 1 Arm 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 17 (5.88%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Cardiac Arrest
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm 1 Arm 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 17 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Dec 2017
    Amendment to the protocol: Change of the primary endpoint. Change of the sample size.

    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/32723374
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