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    Clinical Trial Results:
    The role of immunosuppressives in immunosenescence and immunotolerance in renal transplantation

    Summary
    EudraCT number
    		 2011-003604-21
    Trial protocol
    		 AT  
    Global end of trial date
    05 Apr 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Sep 2020
    First version publication date
    17 Sep 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    KT-IBA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52 A, Innsbruck, Austria, 6020
    Public contact
    Christian Koppelstätter, Medical University Innsbruck, University Hospital for Internal Medicine IV, +43 51250425885, christian.koppelstaetter@tirol-kliniken.at
    Scientific contact
    Christian Koppelstätter, Medical University Innsbruck, University Hospital for Internal Medicine IV, +43 51250425885, christian.koppelstaetter@tirol-kliniken.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
    Final
    Date of interim/final analysis
    05 Apr 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Apr 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In the present study we investigated the effect of longterm (> 1 year after kidney transplantation) immunosuppressive therapy on T cells from kidney transplanted patients of different age and compared the results to agematched healthy individuals. We also analysed the influence of latent CMV infection on the T cell pool of patients and controls.
    Protection of trial subjects
    One blood sample was taken from kidney transplanted patients under immunosuppressive therapy as well as from age-matched healthy controls.
    Background therapy
    		 All patients were under immunosuppressive therapy. Treatment regimens varied among patients, but were similar for the different age groups. The most commonly used combination of immunosuppressive drugs was tacrolimus with mycophenolate mofetil (MMF) and cortisone (22·1%).
    Evidence for comparator
    		 No comparators were used.
    Actual start date of recruitment
    18 Nov 2011
    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: 78
    Worldwide total number of subjects
    78
    EEA total number of subjects
    78
    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)
    53
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who underwent a kidney tranplanation at the University Hospital for Internal Medicine IV one or more years ago and who were under immunosuppressive treatment.

    Pre-assignment
    Screening details
    		 Indications for transplantation varied greatly among patients. All patients were under immunosuppressive therapy. Patients with symptoms of chronic or acute rejection and patients with impaired transplant function were excluded from the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Young participants
    Arm description
    		 In this study, T cell function and the composition of the T cell repertoire were analysed in immunosuppressed renal transplant recipients of different age and cytomegalovirus (CMV) status in comparison to age- and CMV-matched controls.
    Arm type
    		 long-term immunosuppressive therapy

    Investigational medicinal product name
    Certican
    Investigational medicinal product code
    Other name
    Everolimus
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients were under immunosuppressive therapy. Treatment regimens varied among patients, but were similar for the different age groups.

    Investigational medicinal product name
    Rapamune
    Investigational medicinal product code
    Other name
    Sirolismus
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients were under immunosuppressive therapy. Treatment regimens varied among patients, but were similar for the different age groups.

    Investigational medicinal product name
    Sandimmun
    Investigational medicinal product code
    Other name
    Cyclosporin
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    All patients were under immunosuppressive therapy. Treatment regimens varied among patients, but were similar for the different age groups.

    Investigational medicinal product name
    Prograf
    Investigational medicinal product code
    Other name
    Tacrolimus
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    All patients were under immunosuppressive therapy. Treatment regimens varied among patients, but were similar for the different age groups.

    Arm title
    		 Middle-aged participants
    Arm description
    		 In this study, T cell function and the composition of the T cell repertoire were analysed in immunosuppressed renal transplant recipients of different age and cytomegalovirus (CMV) status in comparison to age- and CMV-matched controls.
    Arm type
    		 long-term immunosuppressive therapy

    Investigational medicinal product name
    Certican
    Investigational medicinal product code
    Other name
    Everolimus
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients were under immunosuppressive therapy. Treatment regimens varied among patients, but were similar for the different age groups.

    Investigational medicinal product name
    Rapamune
    Investigational medicinal product code
    Other name
    Sirolismus
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients were under immunosuppressive therapy. Treatment regimens varied among patients, but were similar for the different age groups.

    Investigational medicinal product name
    Sandimmun
    Investigational medicinal product code
    Other name
    Cyclosporin
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    All patients were under immunosuppressive therapy. Treatment regimens varied among patients, but were similar for the different age groups.

    Investigational medicinal product name
    Prograf
    Investigational medicinal product code
    Other name
    Tacrolimus
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    All patients were under immunosuppressive therapy. Treatment regimens varied among patients, but were similar for the different age groups.

    Arm title
    		 Elderly participants
    Arm description
    		 In this study, T cell function and the composition of the T cell repertoire were analysed in immunosuppressed renal transplant recipients of different age and cytomegalovirus (CMV) status in comparison to age- and CMV-matched controls.
    Arm type
    		 long-term immunosuppressive therapy

    Investigational medicinal product name
    Certican
    Investigational medicinal product code
    Other name
    Everolimus
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients were under immunosuppressive therapy. Treatment regimens varied among patients, but were similar for the different age groups.

    Investigational medicinal product name
    Rapamune
    Investigational medicinal product code
    Other name
    Sirolismus
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients were under immunosuppressive therapy. Treatment regimens varied among patients, but were similar for the different age groups.

    Investigational medicinal product name
    Sandimmun
    Investigational medicinal product code
    Other name
    Cyclosporin
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    All patients were under immunosuppressive therapy. Treatment regimens varied among patients, but were similar for the different age groups.

    Investigational medicinal product name
    Prograf
    Investigational medicinal product code
    Other name
    Tacrolimus
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    All patients were under immunosuppressive therapy. Treatment regimens varied among patients, but were similar for the different age groups.

    Number of subjects in period 1
    		Young participants Middle-aged participants Elderly participants
    Started
    21
    32
    25
    Completed
    21
    32
    25

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Young participants
    Reporting group description
    		 In this study, T cell function and the composition of the T cell repertoire were analysed in immunosuppressed renal transplant recipients of different age and cytomegalovirus (CMV) status in comparison to age- and CMV-matched controls.

    Reporting group title
    Middle-aged participants
    Reporting group description
    		 In this study, T cell function and the composition of the T cell repertoire were analysed in immunosuppressed renal transplant recipients of different age and cytomegalovirus (CMV) status in comparison to age- and CMV-matched controls.

    Reporting group title
    Elderly participants
    Reporting group description
    		 In this study, T cell function and the composition of the T cell repertoire were analysed in immunosuppressed renal transplant recipients of different age and cytomegalovirus (CMV) status in comparison to age- and CMV-matched controls.

    Reporting group values
    		 Young participants Middle-aged participants Elderly participants Total
    Number of subjects
    		 21 32 25 78
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 21 32 0 53
        From 65-84 years
    		 0 0 25 25
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 5 8 12 25
        Male
    		 16 24 13 53

    End points

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    End points reporting groups
    Reporting group title
    Young participants
    Reporting group description
    		 In this study, T cell function and the composition of the T cell repertoire were analysed in immunosuppressed renal transplant recipients of different age and cytomegalovirus (CMV) status in comparison to age- and CMV-matched controls.

    Reporting group title
    Middle-aged participants
    Reporting group description
    		 In this study, T cell function and the composition of the T cell repertoire were analysed in immunosuppressed renal transplant recipients of different age and cytomegalovirus (CMV) status in comparison to age- and CMV-matched controls.

    Reporting group title
    Elderly participants
    Reporting group description
    		 In this study, T cell function and the composition of the T cell repertoire were analysed in immunosuppressed renal transplant recipients of different age and cytomegalovirus (CMV) status in comparison to age- and CMV-matched controls.

    Subject analysis set title
    Healthy controls, young
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    In addition, peripheral blood was obtained from healthy age-matched control patients.

    Subject analysis set title
    Healthy controls, middle aged
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    In addition, peripheral blood was obtained from healthy age-matchedcontrol patients.

    Subject analysis set title
    Healthy controls, elderly
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    In addition, peripheral blood was obtained from healthy age-matchedcontrol patients.

    Primary: CD4+ T cell subsets in healthy controls (HC) and kidney transplanted immunosuppressed patients (KTx)

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    End point title
    		 CD4+ T cell subsets in healthy controls (HC) and kidney transplanted immunosuppressed patients (KTx)
    End point description
    Analysis of CD4+ effector memory (CD45RO+CD28−) cells in subjects without latent cytomegalovirus (CMV) infection
    End point type
    Primary
    End point timeframe
    >1 year after kidney transplantation
    End point values
    		 Young participants Middle-aged participants Elderly participants Healthy controls, young Healthy controls, middle aged Healthy controls, elderly
    Number of subjects analysed
    8
    8
    4
    27
    4
    19
    Units: Percentage
        arithmetic mean (standard error)
    2.5 ( 1.7 )
    5.4 ( 1.2 )
    7.0 ( 5.4 )
    0.5 ( 0.1 )
    0.6 ( 0.3 )
    0.6 ( 0.1 )
    Statistical analysis title
    		 CD45RO+CD28− in HC and KTx, CMV negative, young
    Comparison groups
    Young participants v Healthy controls, young
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.041
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 CD45RO+CD28− in HC and KTx, CMV negative, middle
    Comparison groups
    Middle-aged participants v Healthy controls, middle aged
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.013
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 CD45RO+CD28− in HC and KTx, CMV negative, elderly
    Comparison groups
    Elderly participants v Healthy controls, elderly
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.009
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: CD4+ T cell subsets in healthy controls (HC) and kidney transplanted immunosuppressed patients (KTx)

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    End point title
    		 CD4+ T cell subsets in healthy controls (HC) and kidney transplanted immunosuppressed patients (KTx)
    End point description
    Analysis of CD4+ effector memory (CD45RO+CD28−) cells in subjects with latent cytomegalovirus (CMV) infection
    End point type
    Primary
    End point timeframe
    >1 year after kidney transplantation
    End point values
    		 Young participants Middle-aged participants Elderly participants Healthy controls, young Healthy controls, middle aged Healthy controls, elderly
    Number of subjects analysed
    8
    9
    14
    12
    6
    22
    Units: Percentage
        arithmetic mean (standard error)
    4.9 ( 1.8 )
    5.9 ( 1.7 )
    9.3 ( 1.9 )
    3.5 ( 1.2 )
    3.8 ( 1.4 )
    5.3 ( 0.9 )
    Statistical analysis title
    		 CD45RO+CD28− in HC and KTx, CMV positive, young
    Comparison groups
    Young participants v Healthy controls, young
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.505
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 CD45RO+CD28− in HC and KTx, CMV positive, middle
    Comparison groups
    Middle-aged participants v Healthy controls, middle aged
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.38
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 CD45RO+CD28− in HC and KTx, CMV positive, elderly
    Comparison groups
    Elderly participants v Healthy controls, elderly
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.04
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: CD4+ T cell subsets in healthy controls (HC) and kidney transplanted immunosuppressed patients (KTx)

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    End point title
    		 CD4+ T cell subsets in healthy controls (HC) and kidney transplanted immunosuppressed patients (KTx)
    End point description
    Analysis of CD4+ effector memory (CD45RO−CD28−) cells in subjects without latent cytomegalovirus (CMV) infection
    End point type
    Primary
    End point timeframe
    >1 year after kidney transplantation
    End point values
    		 Young participants Middle-aged participants Elderly participants Healthy controls, young Healthy controls, middle aged Healthy controls, elderly
    Number of subjects analysed
    8
    8
    4
    27
    4
    19
    Units: Percentage
        arithmetic mean (standard error)
    5.4 ( 1.3 )
    12.5 ( 2.6 )
    10.0 ( 2.7 )
    0.9 ( 0.2 )
    2.7 ( 1.4 )
    0.7 ( 0.1 )
    Statistical analysis title
    		 CD45RO-CD28− in HC and KTx, CMV negative, young
    Comparison groups
    Young participants v Healthy controls, young
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 CD45RO-CD28− in HC and KTx, CMV negative, middle
    Comparison groups
    Middle-aged participants v Healthy controls, middle aged
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.023
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 CD45RO-CD28− in HC and KTx, CMV negative, elderly
    Comparison groups
    Elderly participants v Healthy controls, elderly
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: CD4+ T cell subsets in healthy controls (HC) and kidney transplanted immunosuppressed patients (KTx)

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    End point title
    		 CD4+ T cell subsets in healthy controls (HC) and kidney transplanted immunosuppressed patients (KTx)
    End point description
    Analysis of CD4+ effector memory (CD45RO−CD28−) cells in subjects with latent cytomegalovirus (CMV) infection
    End point type
    Primary
    End point timeframe
    >1 year after kidney transplantation
    End point values
    		 Young participants Middle-aged participants Elderly participants Healthy controls, young Healthy controls, middle aged Healthy controls, elderly
    Number of subjects analysed
    8
    9
    14
    12
    6
    22
    Units: Percentage
        arithmetic mean (standard error)
    8.1 ( 2.9 )
    12.3 ( 3.7 )
    18.8 ( 3.9 )
    2.6 ( 1.2 )
    6.5 ( 1.5 )
    5.7 ( 1.1 )
    Statistical analysis title
    		 CD45RO-CD28− in HC and KTx, CMV positive, young
    Comparison groups
    Young participants v Healthy controls, young
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.064
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 CD45RO-CD28− in HC and KTx, CMV positive, middle
    Comparison groups
    Middle-aged participants v Healthy controls, middle aged
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.223
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 CD45RO-CD28− in HC and KTx, CMV positive, elderly
    Comparison groups
    Elderly participants v Healthy controls, elderly
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Proliferation index of T cells

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    End point title
    		 Proliferation index of T cells
    End point description
    Proliferation index of T cells from healthy subjects (HC) and kidney transplanted patients (KTx)stimulated with anti-CD3 (3 ng/ml) and cultured in medium containing 10 % fetal calf serum (FCS) for 5 days. Proliferation was assessed by carboxyfluorescein succinimidyl ester (CFSE) staining and is expressed as proliferation index.
    End point type
    Secondary
    End point timeframe
    >1 year after kidney transplantation
    End point values
    		 Young participants Middle-aged participants Elderly participants Healthy controls, young Healthy controls, middle aged Healthy controls, elderly
    Number of subjects analysed
    13
    13
    20
    16
    1
    17
    Units: proliferation index
        arithmetic mean (standard error)
    51.9 ( 5.6 )
    65.5 ( 4.8 )
    58.0 ( 3.4 )
    61.0 ( 3.7 )
    60.1 ( 0.0 )
    64.4 ( 3.1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    18.11.2011- 05.04.2013
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    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: As there were no interventions in this trial, no AEs or SAEs were observed.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24028181
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