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    Clinical Trial Results:
    Bortezomib in late antibody-mediated kidney transplant rejection (BORTEJECT Study)

    Summary
    EudraCT number
    		 2012-002857-41
    Trial protocol
    		 AT  
    Global end of trial date
    23 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Mar 2020
    First version publication date
    20 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BORTEJECT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01873157
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienna, Austria, 1090
    Public contact
    Abt. für Nephrologie und Dialyse, Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, 0043 014040043630, georg.boehmig@meduniwien.ac.at
    Scientific contact
    Abt. für Nephrologie und Dialyse, Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, 0043 014040043630, georg.boehmig@meduniwien.ac.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
    01 Mar 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the planned non-commercial investigator-initiated and -driven study is to assess the efficiency of the innovative concept of proteasome inhibition in the treatment of late AMR. Our primary hypothesis is that, by inhibiting alloantibody production bortezomib halts the progression of ongoing graft injury and dysfunction.
    Protection of trial subjects
    The study was conducted in conformance with Good Clinical Practice standards and local statutes and regulations regarding ethical committee review. Safety evaluation included a monitoring of all adverse events that occurred throughout the 24-month study period, as defined by the International Conference on Harmonization guidelines and World Health Organization Good Clinical Practice guidelines. The following measures were repeatedly assessed throughout the course of the study to monitor subject safety: assessment of adverse events, clinical laboratory tests, medical history, and vital signs assessment. An independent data and safety monitoring board (DSMB) monitored all safety issues and reviewed data at the interim analyses. Interim analyses were performed after completion of 10 and 20 cases.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 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
    Austria: 44
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    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)
    36
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited at the outpatient ward (in the context of routine visits) of the Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Austria (Between Oct 2013 and Feb 2015: 1165 patients registered; 741 subjected to ABMR screening), according to HLA antibody/ABMR screening results.

    Pre-assignment
    Screening details
    		 Screening included 1076 kidney transplant recipients registered between Oct 2013 and Feb 2014 (age >18 years, ≥180 days post-transplantation, eGFR >20 ml/min/1.73 m2); 741 patients were subjected to serological DSA screening. Of those 86 DSA+ patients underwent biopsies and 45 were eligible. 44 patients entered the RCT (1 withdrawal after randomiza

    Period 1
    Period 1 title
    RCT (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Randomisation was conducted by members of the pharmacy of the General Hospital of Vienna, using a password-protected web based system (web-based randomizer of the Medical University of Vienna. Patients were randomised on a 1:1 ratio to either Velcade or Placebo. The study was double-blind (subjects, investigators, monitor, data analysis).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bortezomib
    Arm description
    		 Bortezomib
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bortezomib
    Investigational medicinal product code
    ATC group: L01XX32
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Patients received two cycles of bortezomib. Each treatment cycle consisted of bortezomib at 1.3 mg/m2, administered intravenously twice weekly on days 1, 4, 8 and 11.

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    A 0.9% sodium chloride solution (normal saline solution) was used as placebo.

    Number of subjects in period 1
    		Bortezomib Placebo
    Started
    21
    23
    Completed
    21
    23

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RCT
    Reporting group description
    		 -

    Reporting group values
    		 RCT Total
    Number of subjects
    		 44 44
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 36 36
        From 65-84 years
    		 8 8
        85 years and over
    		 0 0
    Age continuous
    Median age (IQR)
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 55.7 (43.3 to 60.9) -
    Gender categorical
    Proportion of female reccipients
    Units: Subjects
        Female
    		 26 26
        Male
    		 18 18
    DSA positive
    Luminex single antigen test-based detection of DSA against the organ donor.
    Units: Subjects
        DSA-positive
    		 44 44
    ABMR-specific features on biopsy
    Detection of ABMR-specific features on biopsy
    Units: Subjects
        ABMR features
    		 44 44

    End points

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    End points reporting groups
    Reporting group title
    Bortezomib
    Reporting group description
    		 Bortezomib

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Slope of the estimated glomerular filtration rate

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    End point title
    		 Slope of the estimated glomerular filtration rate
    End point description
    The eGFR was calculated according to the Mayo equation.
    End point type
    Primary
    End point timeframe
    The slope of eGFR was computed from measurements at 0, 6, 12, 18 and 24 months.
    End point values
    		 Bortezomib Placebo
    Number of subjects analysed
    21
    23
    Units: ml/min/1.73 m2 per year
        arithmetic mean (confidence interval 95%)
    -4.7 (-8.6 to -0.8)
    -5.2 (-8.9 to -1.4)
    Statistical analysis title
    		 Linear mixed model for eGFR slope comparison
    Statistical analysis description
    GFR trajectories were analyzed using a mixed linear model with eGFR values from 0 to 24 months as dependent, and time and the interaction of treatment and time, as fixed effects. Furthermore, patient-specific random effects for intercept and slope were specified. The covariance structure was specified as an autoregressive model of the first order. The null hypothesis that the coefficient of the interaction term treatment and time is zero was tested at a two-sided significance level of 5%.
    Comparison groups
    Placebo v Bortezomib
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.86
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.81
         upper limit
    		 5.75
    Notes
    [1] - Linear mixed model

    Secondary: HLA antibody levels

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    End point title
    		 HLA antibody levels
    End point description
    Median of the mean fluorescence intinsity of the immunodominant DSA at 24 months
    End point type
    Secondary
    End point timeframe
    Measurement at month 24
    End point values
    		 Bortezomib Placebo
    Number of subjects analysed
    18
    22
    Units: no unit
    median (inter-quartile range (Q1-Q3))
        DSA-MFI
    5365 (1728 to 11812)
    2255 (1075 to 11697)
    Statistical analysis title
    		 Group comparison for DSA-MFI
    Statistical analysis description
    Mann Whitney U test
    Comparison groups
    Placebo v Bortezomib
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.49
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [2] - Mann Whitney U test

    Secondary: Death-censored graft loss

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    End point title
    		 Death-censored graft loss
    End point description
    Death censored graft survival
    End point type
    Secondary
    End point timeframe
    Until the end-of follow-up at 24 months
    End point values
    		 Bortezomib Placebo
    Number of subjects analysed
    21
    23
    Units: Number
        Graft loss
    3
    1
    Statistical analysis title
    		 Kaplan Meier analysis for survival assessment
    Statistical analysis description
    The log rank test was used for group comparison.
    Comparison groups
    Placebo v Bortezomib
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.23
    Method
    		 Logrank
    Confidence interval

    Secondary: Measured GFR

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    End point title
    		 Measured GFR
    End point description
    Clearance of chromium-51 ethylenediaminetetraacetic acid based on the slope-intercept method
    End point type
    Secondary
    End point timeframe
    Measurement at 24 months
    End point values
    		 Bortezomib Placebo
    Number of subjects analysed
    17
    22
    Units: ml/min/1.73 m2
        median (inter-quartile range (Q1-Q3))
    33 (28 to 39)
    42 (23 to 49)
    Statistical analysis title
    		 Group comparison for mGFR
    Statistical analysis description
    For group comparison the Mann Whitney U test was used
    Comparison groups
    Bortezomib v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.31
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [3] - For group comparison the Mann Whitney U test was used.

    Secondary: Microcirculation inflammation

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    End point title
    		 Microcirculation inflammation
    End point description
    Sum of g and ptc Banff scores
    End point type
    Secondary
    End point timeframe
    Measurement in biopsies performed at the end of follow-up at 24 months.
    End point values
    		 Bortezomib Placebo
    Number of subjects analysed
    16
    22
    Units: score
        median (inter-quartile range (Q1-Q3))
    4 (0 to 5)
    2 (1 to 5)
    Statistical analysis title
    		 Group comparison for microcirculation inflammation
    Statistical analysis description
    For group comparison with respect to microcirculation inflammation the Mann Whitney U test was used.
    Comparison groups
    Bortezomib v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.87
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [4] - For group comparison the Mann Whitney U test was used.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the baseline visit untel the end-of the study period at 24 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 as reported
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Bortezomib
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Bortezomib Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 21 (28.57%)
    3 / 23 (13.04%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
    Additional description: NSTEMI
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal cancer metastatic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    LUMBAR syndrome
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Bortezomib Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 21 (90.48%)
    21 / 23 (91.30%)
    Vascular disorders
    Oedema
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Cardiac disorders
    Cardiovascular disease
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Arrhythmia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 23 (8.70%)
         occurrences all number
    2
    2
    Restless legs syndrome
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    0
    Headache
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 23 (13.04%)
         occurrences all number
    2
    3
    Fatigue
         subjects affected / exposed
    6 / 21 (28.57%)
    3 / 23 (13.04%)
         occurrences all number
    6
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 21 (19.05%)
    0 / 23 (0.00%)
         occurrences all number
    4
    0
    Dysphagia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    13 / 21 (61.90%)
    5 / 23 (21.74%)
         occurrences all number
    13
    5
    Obstipation
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Pancreatitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    lip carcinoma
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Basal cell carcinoma
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Actinic keratosis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Stasis dermatitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Prostate cancer
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Endocrine disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Hyperthyreosis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    LUMBAR syndrome
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Arthralgia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 21 (38.10%)
    12 / 23 (52.17%)
         occurrences all number
    8
    12
    Pneumonia
         subjects affected / exposed
    2 / 21 (9.52%)
    4 / 23 (17.39%)
         occurrences all number
    2
    4
    Urinary tract infection
         subjects affected / exposed
    5 / 21 (23.81%)
    2 / 23 (8.70%)
         occurrences all number
    5
    2
    dental infection
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Herpes simplex
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Influenza
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Polyomavirus-associated nephropathy
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29242250
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