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    Clinical Trial Results:
    A randomized controlled clinical trial to determine if a combined screening /treatment programme can prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies.

    Summary
    EudraCT number
    		 2012-004308-36
    Trial protocol
    		 GB  
    Global end of trial date
    29 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Mar 2023
    First version publication date
    12 Mar 2023
    Other versions
    Summary report(s)
    		 CSR OUTSMART

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    OuTSMART
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Anthony Dorling, Kings College London, 44 207188 5880 , anthony.dorling@kcl.ac.uk
    Scientific contact
    Anthony Dorling, Kings College London, 44 207188 5880 , anthony.dorling@kcl.ac.uk
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Anthony Dorling, Guy's and St Thomas' Foundation NHS Trust, 44 0207188 5880 , anthony.dorling@kcl.ac.uk
    Scientific contact
    Anthony Dorling, Guy's and St Thomas' Foundation NHS Trust, 44 0207188 5880 , anthony.dorling@kcl.ac.uk
    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
    18 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Nov 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determine the time to graft failure in patients testing positive for HLA Ab at baseline or within 32 months of randomization who receive an optimized anti-rejection medication intervention with prednisone, Tac and MMF (‘treatment’), compared to a control group who test positive for HLA Ab at baseline or within 32 months post-randomization who remain on their established immunotherapy and whose clinicians are not aware of their Ab status.
    Protection of trial subjects
    Participants have the right to withdraw from the study at any time for any reason. The investigator also has the right to withdraw patients from the study drug in the event of inter-current illness, AEs, SAE’s, SUSAR’s, protocol violations, cure, administrative reasons or other reasons
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Sep 2013
    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
    United Kingdom: 2037
    Worldwide total number of subjects
    2037
    EEA total number of subjects
    2037
    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)
    1767
    From 65 to 84 years
    270
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 2094 [1]
    Number of subjects completed
    		 2037

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 screen fail: 57
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The pre assignment period includes screen failures who were not enrolled
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DSA BLC (B1)
    Arm description
    		 Positive for Donor Specific Antibodies Biomarker Led Care
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mycophenolic Acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Mycophenolate mofetil bd, tds or qds, or enteric coated mycophenolic acid bd, with daily dose determined according to local unit guidelines. The patient will be stabilized on the maximum tolerated dose.

    Investigational medicinal product name
    Tacrolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Tacrolimus od or bd, according to local unit preference, with dose titrated to achieve 12-hour post-dose levels of 4g/L to 8g/L (4-8 ng/ml). The patient will be stabilized on the maximum tolerated dose that achieves these levels.

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Prednisolone od. Starting at 20mg for two weeks, then reducing by 5 mg od every two weeks down to their previous maintenance dose or 5mg od, if not previously taking.

    Arm title
    		 DSA SC (A1)
    Arm description
    		 Positive Donor specific antibodies blinded standard care
    Arm type
    		 standard of care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Non-DSA BLC (B2)
    Arm description
    		 Positive non- Donor specific antibodies Biomarker Led Care
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mycophenolic Acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Mycophenolate mofetil bd, tds or qds, or enteric coated mycophenolic acid bd, with daily dose determined according to local unit guidelines. The patient will be stabilized on the maximum tolerated dose.

    Investigational medicinal product name
    Tacrolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Tacrolimus od or bd, according to local unit preference, with dose titrated to achieve 12-hour post-dose levels of 4g/L to 8g/L (4-8 ng/ml). The patient will be stabilized on the maximum tolerated dose that achieves these levels.

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Prednisolone od. Starting at 20mg for two weeks, then reducing by 5 mg od every two weeks down to their previous maintenance dose or 5mg od, if not previously taking.

    Arm title
    		 Neg Unblinded (D)
    Arm description
    		 HLA Ab negative unblinded standard of care
    Arm type
    		 standard of care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Neg Blinded (C)
    Arm description
    		 HLA ab negative blinded standard of care
    Arm type
    		 standard of care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Non DSA SC (A2)
    Arm description
    		 Positive non- Donor specific antibodies Standard of care
    Arm type
    		 standard of care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		DSA BLC (B1) DSA SC (A1) Non-DSA BLC (B2) Neg Unblinded (D) Neg Blinded (C) Non DSA SC (A2)
    Started
    106
    92
    427
    495
    526
    391
    Completed
    97
    83
    374
    421
    450
    344
    Not completed
    9
    9
    53
    74
    76
    47
         randomised in error
    -
    -
    -
    -
    2
    -
         Lost to follow-up
    9
    9
    53
    74
    74
    47

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DSA BLC (B1)
    Reporting group description
    		 Positive for Donor Specific Antibodies Biomarker Led Care

    Reporting group title
    DSA SC (A1)
    Reporting group description
    		 Positive Donor specific antibodies blinded standard care

    Reporting group title
    Non-DSA BLC (B2)
    Reporting group description
    		 Positive non- Donor specific antibodies Biomarker Led Care

    Reporting group title
    Neg Unblinded (D)
    Reporting group description
    		 HLA Ab negative unblinded standard of care

    Reporting group title
    Neg Blinded (C)
    Reporting group description
    		 HLA ab negative blinded standard of care

    Reporting group title
    Non DSA SC (A2)
    Reporting group description
    		 Positive non- Donor specific antibodies Standard of care

    Reporting group values
    		 DSA BLC (B1) DSA SC (A1) Non-DSA BLC (B2) Neg Unblinded (D) Neg Blinded (C) Non DSA SC (A2) Total
    Number of subjects
    		 106 92 427 495 526 391 2037
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.8 ± 14.0 48.1 ± 13.7 50.3 ± 12.6 51.0 ± 13.3 51.1 ± 12.7 49.4 ± 12.7 -
    Gender categorical
    Units: Subjects
        Female
    		 20 26 176 123 145 152 642
        Male
    		 86 66 251 372 381 239 1395

    End points

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    End points reporting groups
    Reporting group title
    DSA BLC (B1)
    Reporting group description
    		 Positive for Donor Specific Antibodies Biomarker Led Care

    Reporting group title
    DSA SC (A1)
    Reporting group description
    		 Positive Donor specific antibodies blinded standard care

    Reporting group title
    Non-DSA BLC (B2)
    Reporting group description
    		 Positive non- Donor specific antibodies Biomarker Led Care

    Reporting group title
    Neg Unblinded (D)
    Reporting group description
    		 HLA Ab negative unblinded standard of care

    Reporting group title
    Neg Blinded (C)
    Reporting group description
    		 HLA ab negative blinded standard of care

    Reporting group title
    Non DSA SC (A2)
    Reporting group description
    		 Positive non- Donor specific antibodies Standard of care

    Primary: Time to Graft Failure

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    End point title
    		 Time to Graft Failure [1]
    End point description
    Time to graft failure in HLA Ab positive patients randomized to biomarker-led treatment groups vs. time to graft failure in HLA Ab positive patients randomized to the control (standard care) group. Graft failure was defined as re-starting dialysis or requiring a new transplant.
    End point type
    Primary
    End point timeframe
    Date of recruitment to month 92.
    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: Please see separate attachment
    End point values
    		 DSA BLC (B1) DSA SC (A1) Non-DSA BLC (B2) Neg Unblinded (D) Neg Blinded (C) Non DSA SC (A2)
    Number of subjects analysed
    106
    91
    427
    495
    524
    391
    Units: Number of Graft Failures
        0-1 years
    5
    1
    2
    2
    1
    1
        1-2 years
    6
    3
    6
    6
    6
    8
        2-3 years
    3
    4
    6
    3
    9
    4
        3-4 years
    0
    2
    5
    10
    5
    5
        4-5 years
    3
    1
    4
    0
    7
    2
        5-6 years
    2
    0
    0
    1
    0
    2
        6-7 years
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    AEs were collected from start of treatment to month 32
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Body System Code
    Dictionary version
    1
    Reporting groups
    Reporting group title
    DSA BLC (B1)
    Reporting group description
    		 Positive for Donor Specific Antibodies Biomarker Led Care

    Reporting group title
    DSA SC (A1)
    Reporting group description
    		 Positive Donor specific antibodies blinded standard care

    Reporting group title
    Non-DSA BLC (B2)
    Reporting group description
    		 Positive non- Donor specific antibodies Biomarker Led Care

    Reporting group title
    Neg Unblinded (D)
    Reporting group description
    		 HLA Ab negative unblinded standard of care

    Reporting group title
    Neg Blinded (C)
    Reporting group description
    		 HLA ab negative blinded standard of care

    Reporting group title
    Non DSA SC (A2)
    Reporting group description
    		 Positive non- Donor specific antibodies Standard of care

    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: Please see attachment that includes a summary of adverse events
    Serious adverse events
    		 DSA BLC (B1) DSA SC (A1) Non-DSA BLC (B2) Neg Unblinded (D) Neg Blinded (C) Non DSA SC (A2)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 106 (24.53%)
    18 / 92 (19.57%)
    93 / 427 (21.78%)
    85 / 492 (17.28%)
    88 / 526 (16.73%)
    65 / 391 (16.62%)
         number of deaths (all causes)
    6
    3
    37
    52
    50
    28
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasia
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 92 (0.00%)
    3 / 427 (0.70%)
    1 / 492 (0.20%)
    1 / 526 (0.19%)
    0 / 391 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 3
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    other
         subjects affected / exposed
    5 / 106 (4.72%)
    3 / 92 (3.26%)
    25 / 427 (5.85%)
    15 / 492 (3.05%)
    23 / 526 (4.37%)
    17 / 391 (4.35%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 3
    5 / 30
    0 / 18
    0 / 26
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Immunological
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 92 (0.00%)
    1 / 427 (0.23%)
    0 / 492 (0.00%)
    0 / 526 (0.00%)
    0 / 391 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory
         subjects affected / exposed
    5 / 106 (4.72%)
    2 / 92 (2.17%)
    13 / 427 (3.04%)
    11 / 492 (2.24%)
    17 / 526 (3.23%)
    12 / 391 (3.07%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 2
    5 / 15
    0 / 12
    0 / 24
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychological
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 92 (0.00%)
    0 / 427 (0.00%)
    0 / 492 (0.00%)
    0 / 526 (0.00%)
    2 / 391 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiovascular disorder
         subjects affected / exposed
    4 / 106 (3.77%)
    0 / 92 (0.00%)
    13 / 427 (3.04%)
    14 / 492 (2.85%)
    6 / 526 (1.14%)
    6 / 391 (1.53%)
         occurrences causally related to treatment / all
    3 / 8
    0 / 0
    0 / 16
    0 / 17
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Neurological
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 92 (0.00%)
    3 / 427 (0.70%)
    3 / 492 (0.61%)
    4 / 526 (0.76%)
    2 / 391 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 3
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Haematological
         subjects affected / exposed
    2 / 106 (1.89%)
    3 / 92 (3.26%)
    1 / 427 (0.23%)
    4 / 492 (0.81%)
    5 / 526 (0.95%)
    2 / 391 (0.51%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
    1 / 3
    0 / 4
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Eyes, ear, nose, throat
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 92 (1.09%)
    2 / 427 (0.47%)
    0 / 492 (0.00%)
    0 / 526 (0.00%)
    2 / 391 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal
         subjects affected / exposed
    6 / 106 (5.66%)
    5 / 92 (5.43%)
    14 / 427 (3.28%)
    16 / 492 (3.25%)
    26 / 526 (4.94%)
    10 / 391 (2.56%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 5
    2 / 16
    0 / 20
    0 / 35
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 92 (0.00%)
    3 / 427 (0.70%)
    1 / 492 (0.20%)
    1 / 526 (0.19%)
    0 / 391 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 9
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatological
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 92 (0.00%)
    3 / 427 (0.70%)
    3 / 492 (0.61%)
    5 / 526 (0.95%)
    3 / 391 (0.77%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    3 / 3
    0 / 3
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Genito-urinary/renal
         subjects affected / exposed
    14 / 106 (13.21%)
    11 / 92 (11.96%)
    38 / 427 (8.90%)
    29 / 492 (5.89%)
    31 / 526 (5.89%)
    23 / 391 (5.88%)
         occurrences causally related to treatment / all
    3 / 29
    0 / 17
    14 / 53
    0 / 44
    0 / 51
    0 / 37
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Endocrine
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 92 (0.00%)
    3 / 427 (0.70%)
    4 / 492 (0.81%)
    0 / 526 (0.00%)
    4 / 391 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 4
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal
         subjects affected / exposed
    1 / 106 (0.94%)
    2 / 92 (2.17%)
    6 / 427 (1.41%)
    6 / 492 (1.22%)
    5 / 526 (0.95%)
    2 / 391 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 7
    0 / 6
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 DSA BLC (B1) DSA SC (A1) Non-DSA BLC (B2) Neg Unblinded (D) Neg Blinded (C) Non DSA SC (A2)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 92 (0.00%)
    0 / 427 (0.00%)
    0 / 492 (0.00%)
    0 / 526 (0.00%)
    0 / 391 (0.00%)

    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? Yes
    Date
    Interruption
    Restart date
    20 Mar 2020
    The trial was temporarily suspended during the first COVID-19 pandemic (20/03/2020 – 01/09/2020), and date for completion of primary endpoint data collection extended from June 2020 to November 2020.
    01 Sep 2020

    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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