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    Clinical Trial Results:
    Differences in response to treatment with mycophenolic acid (MPA).

    Summary
    EudraCT number
    		 2009-014997-16
    Trial protocol
    		 AT  
    Global end of trial date
    03 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Feb 2021
    First version publication date
    26 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MPASNP1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria,
    Public contact
    Division of Nephrology and Dialysis, Medical University of Vienna, 0043 14040043890, guerkan.sengoelge@meduniwien.ac.at
    Scientific contact
    Division of Nephrology and Dialysis, Medical University of Vienna, 0043 14040043890, guerkan.sengoelge@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
    Interim
    Date of interim/final analysis
    18 Sep 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Detection of functionally relevant SNPs in IMPDH 2 gene.
    Protection of trial subjects
    Insurance for each study subject, exclusion of minors and persons not capable of written informed consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jan 2010
    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: 155
    Worldwide total number of subjects
    155
    EEA total number of subjects
    155
    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)
    102
    From 65 to 84 years
    53
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult kidney allograft recipients

    Pre-assignment
    Screening details
    		 Screening of all adult kidney allograft recipients on a consecutive Basis. Exclusion ctiteria: Pregnancy, Age below 18 years.

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

    Arms
    Arm title
    		 Observation arm
    Arm description
    		 -
    Arm type
    		 Observation arm

    Investigational medicinal product name
    MPA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Standard dosage: 180mg-720mg bid

    Number of subjects in period 1
    		Observation arm
    Started
    155
    Completed
    155

    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
    		 155 155
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 102 102
        From 65-84 years
    		 53 53
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 49 49
        Male
    		 106 106
    Subject analysis sets

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    In this study, subjects with and without kidney transplant rejection were tested for the presence of rs11706052 SNP by genetic sequencing.

    Subject analysis sets values
    		 Overall trial
    Number of subjects
    155
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    102
        From 65-84 years
    53
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    49
        Male
    106

    End points

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    End points reporting groups
    Reporting group title
    Observation arm
    Reporting group description
    		 -

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    In this study, subjects with and without kidney transplant rejection were tested for the presence of rs11706052 SNP by genetic sequencing.

    Primary: IMPDH 2 single nucleotide polymorphisms

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    End point title
    		 IMPDH 2 single nucleotide polymorphisms
    End point description
    End point type
    Primary
    End point timeframe
    Within the study period beginning from the time of kidney transplantation
    End point values
    		 Observation arm Overall trial
    Number of subjects analysed
    155
    155
    Units: number of patients
    155
    155
    Statistical analysis title
    		 logistic regression analysis
    Comparison groups
    Observation arm v Overall trial
    Number of subjects included in analysis
    310
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [1] - In this study, subjects with and without kidney transplant rejection were tested for the presence of rs11706052 SNP by genetic sequencing.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    09.02.2010 - 03.06.2014
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    2014
    Reporting groups
    Reporting group title
    Adverse Event
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse Event
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 155 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Adverse Event
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 155 (9.03%)
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    14 / 155 (9.03%)
         occurrences all number
    25

    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
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    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.

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