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    Clinical Trial Results:
    A MULTICENTRE, SINGLE-ARM, OPEN-LABEL STUDY TO CHARACTERISE THE RELATIONSHIP BETWEEN PRE-TRANSPLANT PHARMACOKINETICS OF ADVAGRAF® AND THE DOSE REQUIRED POST-TRANSPLANT TO ACHIEVE TARGET TROUGH LEVELS IN DE NOVO KIDNEY TRANSPLANT RECIPIENTS

    Summary
    EudraCT number
    		 2013-000985-13
    Trial protocol
    		 ES  
    Global end of trial date
    31 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2019
    First version publication date
    29 Dec 2019
    Other versions
    Summary report(s)
    		 Cancelled Before Active Statement

    Trial information

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    Trial identification
    Sponsor protocol code
    PMR-EC-1214
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Astellas Pharma Europe Ltd.
    Sponsor organisation address
    Sylviusweg 62, Leiden, Netherlands,
    Public contact
    Service Desk, Astellas Pharma Europe B.V., 0031 (0)715455878, contact@nl.astellas.com
    Scientific contact
    Service Desk, Astellas Pharma Europe B.V., 0031 (0)715455878, contact@nl.astellas.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 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess if Advagraf® pharmacokinetic parameters measured prior to transplantation can predict the dose required after transplantation to achieve target trough levels of 10 ng/mL in individual patients.
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Oct 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
    Spain: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 99999 is "Not applicable" value or 0 participants. This trial was discontinued with no participants enrolled in the trial.

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 Advagraf
    Arm description
    		 Advagraf oral capsules
    Arm type
    		 Experimental

    Investigational medicinal product name
    Advagraf
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    This trial was discontinued with no participants enrolled or dosed in the trial.

    Number of subjects in period 1
    		Advagraf
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Advagraf
    Reporting group description
    		 Advagraf oral capsules

    Primary: Dose of tacrolimus required to achieve a trough level of 10 ng/mL on Day 3 after transplantation.

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    End point title
    		 Dose of tacrolimus required to achieve a trough level of 10 ng/mL on Day 3 after transplantation. [1]
    End point description
    99999 is "Not applicable" value or 0 participants. This trial was discontinued with no participants enrolled in the trial.
    End point type
    Primary
    End point timeframe
    Day 3 after transplantation
    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: No statistical analyses were performed. This trial was discontinued with no participants enrolled in the trial.
    End point values
    		 Advagraf
    Number of subjects analysed
    99999 [2]
    Units: Number
    99999
    Notes
    [2] - This trial was discontinued with no participants enrolled in the trial.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Not applicable. This trial was discontinued with no participants enrolled in the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: 99999 is "Not applicable" value or 0 participants. This trial was discontinued with no participants enrolled in the trial.

    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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