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    Clinical Trial Results:
    A randomised controlled comparison of standard release Tacrolimus vs extended-release Tacrolimus as baseline maintenance monotherapy for kidney transplantation after induction with Campath 1-H.

    Summary
    EudraCT number
    		 2008-000889-22
    Trial protocol
    		 GB  
    Global end of trial date
    29 Mar 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Feb 2020
    First version publication date
    08 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ICKTI08TX01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00807144
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College Healthcare NHS Trust
    Sponsor organisation address
    Pread Street, London, United Kingdom, W2 1NY
    Public contact
    Adam McLean, Imperial College Healthcare NHS Trust, adammclean@nhs.net
    Scientific contact
    Adam McLean, Imperial College Healthcare NHS Trust, adammclean@nhs.net
    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
    16 Jan 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Mar 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Mar 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare outcomes of kidney transplantation after induction with Alemtuzumab/short course steroids, followed by maintenance with either standard release Tacrolimus (Prograf) monotherapy, or extended-release tacrolimus (Advagraf) monotherapy. Primary outcome measures: Survival with a functioning graft at 1 year and 3 years.
    Protection of trial subjects
    None
    Background therapy
    		 Alemtuzumab 30mg IV post-operatively. Early steroid withdrawal with Prednisolone: 3 days 60mg then 4 days 30 mg then steroid cessation.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Scientific research
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 102
    Worldwide total number of subjects
    102
    EEA total number of subjects
    102
    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)
    84
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 the recruitment was at Imperial College Kidney & Transplant Centre, Hammersmith Hospital, United Kingdom.

    Pre-assignment
    Screening details
    		 Follow the protocol.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open-labelled

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard release tacrolimus
    Arm description
    		 Participants received Standard release Tacrolimus (Prograf) 0.05 mg/kg twice daily
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tacrolimus
    Investigational medicinal product code
    Other name
    Prograf
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    0.05 mg/kg twice daily

    Arm title
    		 Extended Release Tacrolimus
    Arm description
    		 Participants received Tacrolimus 0.1 mg/kg once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tacrolimus
    Investigational medicinal product code
    Other name
    Advagraf
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    0.1 mg/kg once daily

    Number of subjects in period 1
    		Standard release tacrolimus Extended Release Tacrolimus
    Started
    50
    52
    Completed
    48
    52
    Not completed
    2
    0
         death
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard release tacrolimus
    Reporting group description
    		 Participants received Standard release Tacrolimus (Prograf) 0.05 mg/kg twice daily

    Reporting group title
    Extended Release Tacrolimus
    Reporting group description
    		 Participants received Tacrolimus 0.1 mg/kg once daily

    Reporting group values
    		 Standard release tacrolimus Extended Release Tacrolimus Total
    Number of subjects
    		 50 52 102
    Age categorical
    Units: Subjects
        Adults (50-70years)
    		 50 52 102
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.5 ( 14.4 ) 53.1 ( 15.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 13 13 26
        Male
    		 37 39 76

    End points

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    End points reporting groups
    Reporting group title
    Standard release tacrolimus
    Reporting group description
    		 Participants received Standard release Tacrolimus (Prograf) 0.05 mg/kg twice daily

    Reporting group title
    Extended Release Tacrolimus
    Reporting group description
    		 Participants received Tacrolimus 0.1 mg/kg once daily

    Primary: Survival with functioning graft

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    End point title
    		 Survival with functioning graft
    End point description
    End point type
    Primary
    End point timeframe
    1 year
    End point values
    		 Standard release tacrolimus Extended Release Tacrolimus
    Number of subjects analysed
    50
    52
    Units: percent
        number (not applicable)
    96
    92.3
    Statistical analysis title
    		 Functioning graft
    Comparison groups
    Standard release tacrolimus v Extended Release Tacrolimus
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.26
    Method
    		 Logrank
    Confidence interval

    Secondary: Rejection-free survival year 1

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    End point title
    		 Rejection-free survival year 1
    End point description
    End point type
    Secondary
    End point timeframe
    1 year
    End point values
    		 Standard release tacrolimus Extended Release Tacrolimus
    Number of subjects analysed
    50
    52
    Units: percent
        number (not applicable)
    84
    86
    Statistical analysis title
    		 Rejection-free survival
    Comparison groups
    Standard release tacrolimus v Extended Release Tacrolimus
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.48
    Method
    		 Logrank
    Confidence interval

    Secondary: Rejection-free survival year 2

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    End point title
    		 Rejection-free survival year 2
    End point description
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Standard release tacrolimus Extended Release Tacrolimus
    Number of subjects analysed
    50
    52
    Units: percent
        number (not applicable)
    80.1
    83.4
    Statistical analysis title
    		 Rejection free survival year 2
    Comparison groups
    Standard release tacrolimus v Extended Release Tacrolimus
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.75
    Method
    		 Logrank
    Confidence interval

    Secondary: Mean graft function

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    End point title
    		 Mean graft function
    End point description
    End point type
    Secondary
    End point timeframe
    1 year
    End point values
    		 Standard release tacrolimus Extended Release Tacrolimus
    Number of subjects analysed
    50
    52
    Units: ml/min
        number (confidence interval 95%)
    53.9 (47 to 60)
    54.0 (46.5 to 61.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2 years
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Standard release tacrolimus
    Reporting group description
    		 Participants received Standard release Tacrolimus (Prograf) 0.05 mg/kg twice daily

    Reporting group title
    Extended Release Tacrolimus
    Reporting group description
    		 Participants received Tacrolimus 0.1 mg/kg once daily

    Serious adverse events
    		 Standard release tacrolimus Extended Release Tacrolimus
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Hepatobiliary disorders
    Liver failure
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Standard release tacrolimus Extended Release Tacrolimus
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 50 (18.00%)
    8 / 52 (15.38%)
    General disorders and administration site conditions
    Any rejection symptome
         subjects affected / exposed
    9 / 50 (18.00%)
    8 / 52 (15.38%)
         occurrences all number
    9
    8

    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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