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    Clinical Trial Results:
    Combined low-dose everolimus and low-dose tacrolimus after alemtuzumab induction therapy: a randomized prospective trial in lung transplantation

    Summary
    EudraCT number
    		 2018-001680-24
    Trial protocol
    		 AT  
    Global end of trial date
    23 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Apr 2026
    First version publication date
    11 Apr 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ALiKE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Medical University of Vienna, Division of Thoracic surgery, Medical University of Vienna, 0043 14040056400,
    Scientific contact
    Medical University of Vienna, Division of Thoracic surgery, Medical University of Vienna, 0043 14040056400,
    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
    17 Dec 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 May 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    23 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    -Primary Objective To analyze the effect of the combined use of low-dose everolimus and low-dose tacrolimus after alemtuzumab induction therapy on kidney function, measured as eGFR.
    Protection of trial subjects
    The patients' study visits were sceduled as part of their regular transplant follow-up visits to the outpatient clinic
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2018
    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: 110
    Worldwide total number of subjects
    110
    EEA total number of subjects
    110
    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)
    85
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 bilateral lung transplantation, age greater than 18 years, no pre-transplant colonization of Burkholderia or resistant Mycobacterium abscessus

    Pre-assignment
    Screening details
    		 bilateral lung transplantation, age greater than 18 years, no pre-transplant colonization of Burkholderia or resistant Mycobacterium abscessus, no inclusion in other studies, complete healing of bronchial anastomosis at the time of randomization, no wound infection at the time of randomization

    Period 1
    Period 1 title
    baseline period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 control
    Arm description
    		 Tacrolimus: initial dose: no change compared to pre-randomization dose target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    tacrolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    initial dose: no change compared to pre-randomization dose target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml)

    Arm title
    		 treatment
    Arm description
    		 Everolimus: initial dose: the standard dose of 75mg twice daily, adjusted according to body weight target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml) Tacrolimus: initial dose: half dose of pre-randomization dose target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml)
    Arm type
    		 Experimental

    Investigational medicinal product name
    everolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    initial dose: the standard dose of 75mg twice daily, adjusted according to body weight target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml)

    Investigational medicinal product name
    tacrolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    initial dose: half dose of pre-randomization dose target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml)

    Number of subjects in period 1
    		control treatment
    Started
    56
    54
    Completed
    40
    39
    Not completed
    16
    15
         Adverse event, serious fatal
    9
    4
         regimen changed due to side effects
    5
    10
         re-transplantation
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    control
    Reporting group description
    		 Tacrolimus: initial dose: no change compared to pre-randomization dose target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml)

    Reporting group title
    treatment
    Reporting group description
    		 Everolimus: initial dose: the standard dose of 75mg twice daily, adjusted according to body weight target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml) Tacrolimus: initial dose: half dose of pre-randomization dose target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml)

    Reporting group values
    		 control treatment Total
    Number of subjects
    		 56 54 110
    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)
    		 46 39 85
        From 65-84 years
    		 10 15 25
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 17 21 38
        Male
    		 39 33 72

    End points

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    End points reporting groups
    Reporting group title
    control
    Reporting group description
    		 Tacrolimus: initial dose: no change compared to pre-randomization dose target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml)

    Reporting group title
    treatment
    Reporting group description
    		 Everolimus: initial dose: the standard dose of 75mg twice daily, adjusted according to body weight target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml) Tacrolimus: initial dose: half dose of pre-randomization dose target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml)

    Primary: eGFR

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    End point title
    		 eGFR
    End point description
    End point type
    Primary
    End point timeframe
    24 months
    End point values
    		 control treatment
    Number of subjects analysed
    40
    39
    Units: ml/min/1.73m²
        number (confidence interval 95%)
    69 (61.9 to 76.1)
    68.9 (61.1 to 76.8)
    Statistical analysis title
    		 mixed-effects model for eGFR difference at 24 m
    Comparison groups
    control v treatment
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.475
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from randomization to 24 months post tx
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28
    Reporting groups
    Reporting group title
    control
    Reporting group description
    		 Tacrolimus: initial dose: no change compared to pre-randomization dose target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml)

    Reporting group title
    treatment
    Reporting group description
    		 Everolimus: initial dose: the standard dose of 75mg twice daily, adjusted according to body weight target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml) Tacrolimus: initial dose: half dose of pre-randomization dose target dose: the dose is adjusted according to target drug blood level (1st-3rd mo 4-5 ng/ml, 3rd-12th mo 3-4 ng/ml, 12th-24th mo 2.5 ng/ml)

    Serious adverse events
    		 control treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    32 / 56 (57.14%)
    26 / 54 (48.15%)
         number of deaths (all causes)
    9
    4
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Peripheral vascular disease
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Septum perforation closure
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    7 / 56 (12.50%)
    4 / 54 (7.41%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    6 / 56 (10.71%)
    2 / 54 (3.70%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Respiratory infection
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute allograft rejection
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute cellular rejection
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARDS
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aspiration pneumonia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bilateral pneumonia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lung allograft dysfunction
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnea
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza A H1N1 pneumonia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung transplant rejection
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organizing pneumonia
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory insufficiency
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open wound
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orbital fracture
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative thoracic procedure complication
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Serial rib fracture
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (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
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary vein isolation
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (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
    Cerebral abscess
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Acute appendicitis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon perforation
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epigastric discomfort
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GI bleed
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sigmoid diverticulitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcerative gastritis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney failure
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Kidney stone
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Acute pancreatitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankle fracture
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis of knee
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture L1
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile infection
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CMV infection
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema and pericarditis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 54 (3.70%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory infection
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 54 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SARS-CoV-2 infection
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 54 (3.70%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycemia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatremia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 control treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 56 (78.57%)
    44 / 54 (81.48%)
    Investigations
    CRP increased
         subjects affected / exposed
    12 / 56 (21.43%)
    8 / 54 (14.81%)
         occurrences all number
    12
    10
    Donor specific antibody present
         subjects affected / exposed
    3 / 56 (5.36%)
    4 / 54 (7.41%)
         occurrences all number
    3
    4
    Lung function decreased
         subjects affected / exposed
    6 / 56 (10.71%)
    3 / 54 (5.56%)
         occurrences all number
    7
    4
    Injury, poisoning and procedural complications
    Wound infection
         subjects affected / exposed
    3 / 56 (5.36%)
    5 / 54 (9.26%)
         occurrences all number
    3
    5
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    4 / 56 (7.14%)
    3 / 54 (5.56%)
         occurrences all number
    4
    3
    General disorders and administration site conditions
    Edema
         subjects affected / exposed
    5 / 56 (8.93%)
    10 / 54 (18.52%)
         occurrences all number
    5
    11
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    6 / 56 (10.71%)
    2 / 54 (3.70%)
         occurrences all number
    6
    2
    Gastrointestinal disorders
    Dairrhea
         subjects affected / exposed
    4 / 56 (7.14%)
    7 / 54 (12.96%)
         occurrences all number
    5
    9
    Gastroparesis
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 54 (1.85%)
         occurrences all number
    4
    1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    3 / 56 (5.36%)
    4 / 54 (7.41%)
         occurrences all number
    3
    4
    Pneumonia
         subjects affected / exposed
    4 / 56 (7.14%)
    0 / 54 (0.00%)
         occurrences all number
    4
    0
    Respiratory tract infection
         subjects affected / exposed
    11 / 56 (19.64%)
    5 / 54 (9.26%)
         occurrences all number
    17
    5
    Respiratory tract infection bacterial
         subjects affected / exposed
    5 / 56 (8.93%)
    7 / 54 (12.96%)
         occurrences all number
    6
    8
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 54 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Aspergillus infection
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 54 (1.85%)
         occurrences all number
    4
    1
    CMV infection
         subjects affected / exposed
    6 / 56 (10.71%)
    3 / 54 (5.56%)
         occurrences all number
    7
    3
    SARS-CoV-2 infection
         subjects affected / exposed
    12 / 56 (21.43%)
    12 / 54 (22.22%)
         occurrences all number
    13
    12
    Fungal infection
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 54 (1.85%)
         occurrences all number
    3
    1
    Herpes zoster
         subjects affected / exposed
    0 / 56 (0.00%)
    4 / 54 (7.41%)
         occurrences all number
    0
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 May 2020
    Gene Expression Analysis was included

    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.
    the non-double-blind design may have introduced bias
    For support, Contact us.
    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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