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    Clinical Trial Results:
    A Single Centered, Prospective, Open-labeled, Pharmacokinetic Pilot Study of Tacrolimus Administration via Rectiole

    Summary
    EudraCT number
    		 2014-002425-35
    Trial protocol
    		 NL  
    Global end of trial date
    15 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jan 2018
    First version publication date
    20 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NL2014-002425-35/SpartacusBrindisi
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Medical Center Utrecht
    Sponsor organisation address
    Heidelberglaan 100, Utrecht, Netherlands, 3584 CX
    Public contact
    M.A. Sikma, University Medical Center Utrecht, 0031 887558561, m.a.sikma@umcutrecht.nl
    Scientific contact
    M.A. Sikma, University Medical Center Utrecht, 0031 887558561, m.a.sikma@umcutrecht.nl
    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
    15 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Dec 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Bio-availability of rectal administered tacrolimus
    Protection of trial subjects
    No investigational acts have been conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2015
    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
    Netherlands: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 11 patients have been recruited. They all have granted informed consent. No study procedures have been conducted.

    Pre-assignment
    Screening details
    		 11 patients have granted informed consent, no study procedures have been performed.

    Pre-assignment period milestones
    Number of subjects started
    		 11
    Number of subjects completed
    		 11

    Period 1
    Period 1 title
    inclusion period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    no blinding

    Arms
    Arm title
    		 rectiole
    Arm description
    		 There is one arm in this study. All patients would have been treated the same. No comparator group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    tacrolimus
    Investigational medicinal product code
    Other name
    tacrolimus rectiole
    Pharmaceutical forms
    Rectal solution
    Routes of administration
    Enteral use
    Dosage and administration details
    The starting dose via the rectiole will be 0.025 mg/kg divided in two doses per day or lower based on the whole blood tacrolimus trough concentration of day 1 equal to the intravenous dose. No investigational activities have been conducted.

    Number of subjects in period 1
    		rectiole
    Started
    11
    Completed
    11

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    rectiole
    Reporting group description
    		 There is one arm in this study. All patients would have been treated the same. No comparator group.

    Primary: bioavailability of tacrolimus

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    End point title
    		 bioavailability of tacrolimus [1]
    End point description
    End point type
    Primary
    End point timeframe
    2 years
    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: the study has been preliminary halted due to organisational reasons. No statistical analyses have been performed
    End point values
    		 rectiole
    Number of subjects analysed
    0 [2]
    Units: ng/ml
        median (inter-quartile range (Q1-Q3))
    ( to )
    Notes
    [2] - the study is preliminary halted
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Serious adverse events such as: death, prolongation of existing inpatients’ hospitalization or requiring hospitalization, repeated surgery, significant disability or incapacity, wound complications, serious bleeding (> 1000 ml per day), sepsis, infection,
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Frequency threshold for reporting non-serious adverse events: 0.05%
    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 adverse events have occurred, because the study was preliminary halted

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Dec 2017
    Halt of trial: Due to organisational difficulties to produce the tacrolimus rectiole in our pharmacy, whereby the production process has been stopped. No patient has been exposed to the investigational product. No risk to the patients is therefore expected.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    15 Dec 2017
    Halt of study, because of organisational causes.
    -

    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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