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    Clinical Trial Results:
    Etude prospective, multicentrique, randomisée, en double-aveugle, contrôlée à groupes parallèles, visant à évaluer la balance bénéfice-risque du sevrage progressif d'un inhibiteur de la calcineurine (Tacrolimus) chez des patients transplantés depuis plus de 4 ans et cliniquement sélectionnés

    Summary
    EudraCT number
    		 2010-019574-33
    Trial protocol
    		 FR  
    Global end of trial date
    20 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2017
    First version publication date
    29 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BRD 09/7-D
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01292525
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU Nantes
    Sponsor organisation address
    5 allée de l'Ile Gloriette, Nantes, France, 44093
    Public contact
    Pr GIRAL, Coordinator Investigator, CHU Nantes, +33 0253482835, magali.giral@chu-nantes.fr
    Scientific contact
    Pr GIRAL, Coordinator Investigator, CHU Nantes, +33 0253482835, magali.giral@chu-nantes.fr
    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
    08 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 May 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Démontrer le bénéfice du sevrage du Tacrolimus (Prograf) sur la fonction rénale des patients un an après la fin de la période de sevrage
    Protection of trial subjects
    Very close follow-up of the patients with biological analysis and biopsies if necessary.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    9
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Renal transplant patients for more than 4 years and clinically selected

    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, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tacrolimus
    Arm description
    		 A control group continued conventional therapy, Tacrolimus (Prograf®) ("control" group) and was followed in parallel group "withdrawal" that will stop treatment with Tacrolimus (Prograf®).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tacrolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Buccal use
    Dosage and administration details
    The dosage of Tacrolimus was adjusted to maintain a Tacrolimus blood concentration of between 5 and 10 ng / ml.

    Arm title
    		 Withdrawal of Tacrolimus
    Arm description
    		 Patients randomized to the "withdrawal" group began the protocol with their usual dose of Tacrolimus (Prograf®) (initial dose). The initial dose of tacrolimus (Prograf®) was reduced by one third at visit 3 (day 0) and again a third visit 5 (J60). The complete withdrawal Tacrolimus (Prograf®) began to visit 7 (J120). The withdrawal of Tacrolimus (Prograf®) was obtained in four months. Monitoring of all patients lasted 17 months in total from the screening visit, which corresponded to 12 months after complete withdrawal of Tacrolimus (Prograf®) for patients in the "withdrawal" group.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Buccal use
    Dosage and administration details
    Patients randomized to the "withdrawal" group began the protocol with their usual dose of Tacrolimus (Prograf®) (initial dose). The initial dose of tacrolimus (Prograf®) was reduced by one third at visit 3 (day 0) and again a third visit 5 (J60). The complete withdrawal Tacrolimus (Prograf®) began to visit 7 (J120). The withdrawal of Tacrolimus (Prograf®) was obtained in four months. Monitoring of all patients lasted 17 months in total from the screening visit, which corresponded to 12 months after complete withdrawal of Tacrolimus (Prograf®) for patients in the "withdrawal" group.

    Number of subjects in period 1
    		Tacrolimus Withdrawal of Tacrolimus
    Started
    5
    5
    Completed
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tacrolimus
    Reporting group description
    		 A control group continued conventional therapy, Tacrolimus (Prograf®) ("control" group) and was followed in parallel group "withdrawal" that will stop treatment with Tacrolimus (Prograf®).

    Reporting group title
    Withdrawal of Tacrolimus
    Reporting group description
    		 Patients randomized to the "withdrawal" group began the protocol with their usual dose of Tacrolimus (Prograf®) (initial dose). The initial dose of tacrolimus (Prograf®) was reduced by one third at visit 3 (day 0) and again a third visit 5 (J60). The complete withdrawal Tacrolimus (Prograf®) began to visit 7 (J120). The withdrawal of Tacrolimus (Prograf®) was obtained in four months. Monitoring of all patients lasted 17 months in total from the screening visit, which corresponded to 12 months after complete withdrawal of Tacrolimus (Prograf®) for patients in the "withdrawal" group.

    Reporting group values
    		 Tacrolimus Withdrawal of Tacrolimus Total
    Number of subjects
    		 5 5 10
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 5 4 9
        From 65-84 years
    		 0 1 1
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1 1 2
        Male
    		 4 4 8

    End points

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    End points reporting groups
    Reporting group title
    Tacrolimus
    Reporting group description
    		 A control group continued conventional therapy, Tacrolimus (Prograf®) ("control" group) and was followed in parallel group "withdrawal" that will stop treatment with Tacrolimus (Prograf®).

    Reporting group title
    Withdrawal of Tacrolimus
    Reporting group description
    		 Patients randomized to the "withdrawal" group began the protocol with their usual dose of Tacrolimus (Prograf®) (initial dose). The initial dose of tacrolimus (Prograf®) was reduced by one third at visit 3 (day 0) and again a third visit 5 (J60). The complete withdrawal Tacrolimus (Prograf®) began to visit 7 (J120). The withdrawal of Tacrolimus (Prograf®) was obtained in four months. Monitoring of all patients lasted 17 months in total from the screening visit, which corresponded to 12 months after complete withdrawal of Tacrolimus (Prograf®) for patients in the "withdrawal" group.

    Primary: Renal function

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    End point title
    		 Renal function [1]
    End point description
    The primary endpoint was the improvement of renal function one year after complete withdrawal of Tacrolimus (Prograf®) assessed by measuring the glomerular filtration rate (GFR) calculated by the dosage of cystatin C according to the equation Bricon. The DFG was compared between times J-30 and J480 (1 year after the withdrawal).
    End point type
    Primary
    End point timeframe
    One year after complete withdrawal of Tacrolimus.
    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: Due to the premature discontinuation of the study after the inclusion of 16 patients (including 10 randomized patients), it was not possible to statistically evaluate the primary endpoint of improvement in renal function one year after complete weaning of Tacrolimus (Prograf®) evaluated by measuring the Glomerular Filtration Rate (GFR) calculated by the cystatin C assay according to the Le Bricon equation.
    End point values
    		 Tacrolimus Withdrawal of Tacrolimus
    Number of subjects analysed
    5
    5
    Units: mL/min
        number (not applicable)
    5
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the signature of the consent form until the end of follow-up for the non-serious adverse events and until resolution for the serious adverse events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Tacrolimus
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Tacrolimus Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
    5 / 5 (100.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Antibody positive
         subjects affected / exposed
    1 / 5 (20.00%)
    3 / 5 (60.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Transplant rejection
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 5 (60.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    IgA nephropathy
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Tacrolimus Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
    3 / 5 (60.00%)
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    1 / 5 (20.00%)
    3 / 5 (60.00%)
         occurrences all number
    1
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Apr 2012
    The main changes to the protocole are : - Addition of a new center, - Increase of the inclusion period to 36 months, - Modification of too restrictive inclusion criteria.

    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/27367750
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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
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