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    Clinical Trial Results:
    Single-center pilot study, prospective, open-label, to evaluate the efficacy and safety of immunosuppression low nephrotoxicity, based on the use of ATeGe-Fresenius in patients with renal insufficiency pretransplant liver

    Summary
    EudraCT number
    		 2011-000691-34
    Trial protocol
    		 ES  
    Global end of trial date
    01 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2021
    First version publication date
    27 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ATG-IRA.HVH.10
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01453218
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHIR
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Joaquin Lopez-Soriano, VHIR, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Dra Itxarone Bilbao, Servicio de Cirugía Hepática y Trasplantes, VHIR, 0034 932746113, ibilbao@vhebron.net
    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 Sep 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of an immunosuppressor regimen plus induction therapy with low-dose Anti-human T-lymphocyte globulin (ATG) in preserving renal function and preventing liver rejection in liver transplantation recipients with pretransplant renal dysfunction
    Protection of trial subjects
    The study was conducted in compliance with the provisions of the Declaration of Helsinki and Good Clinical Practice guidelines. This study was approved by the Hospital Vall d’Hebron Institutional Review Board (Barcelona, Spain). All patients provided their written informed consent form prior to initiation of the study and were allowed to withdraw at any time
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 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
    Spain: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    28
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Single centre (Vall Hebron) prospective study. From January 2012 to December 2016, twenty patients received ATG as immunosuppression induction therapy. They were compared with 20 matched patients who received basiliximab immunosuppression induction therapy from January 2005 to December 2011.

    Pre-assignment
    Screening details
    		 Adult patients on the waiting list for LT from brain-dead donors with pre-LT renal dysfunction were included. In cases of cirrhosis due to hepatitis C virus (HCV) infection, negative HCV-RNA was required. Patients in the ATG study group were compared with a historical cohort of patients with pretransplant renal dysfunction

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Prospective study against historical cohort

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Anti-T Lymphocyte Globulin
    Arm description
    		 ATG was intravenously (i.v.) administered on Intensive Care Unit (ICU) admission at a dose of 1mg/kg/ bodyweight. All patients were premedicated with methyl prednisolone 250mg i.v., dexchlorpheniramine 5mg i.v., and paracetamol 1g. Following doses were given on days 2 and 4 with dose adjustment according to CD2/CD3 levels (>20cel/uL). The third dose of ATG on day 4 was omitted if CD2/CD3 levels were below 20 cel/uL and platelet counts <50,000cells/mm3 on the day after the second dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anti-T Lymphocyte Globulin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    ATG was intravenously (i.v.) administered on Intensive Care Unit (ICU) admission at a dose of 1mg/kg/ bodyweight. All patients were premedicated with methylprednisolone 250mg i.v., dexchlorpheniramine 5mg i.v., and paracetamol 1g

    Arm title
    		 Basiliximab
    Arm description
    		 Historical cohort
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Basiliximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients in the BAS group received induction therapy with basiliximab (Simulect; Novartis) 20mg intravenously on day 0 intraoperatively afer allograf reperfusion and on day 4 afer LT.

    Number of subjects in period 1
    		Anti-T Lymphocyte Globulin Basiliximab
    Started
    20
    20
    Completed
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Anti-T Lymphocyte Globulin
    Reporting group description
    		 ATG was intravenously (i.v.) administered on Intensive Care Unit (ICU) admission at a dose of 1mg/kg/ bodyweight. All patients were premedicated with methyl prednisolone 250mg i.v., dexchlorpheniramine 5mg i.v., and paracetamol 1g. Following doses were given on days 2 and 4 with dose adjustment according to CD2/CD3 levels (>20cel/uL). The third dose of ATG on day 4 was omitted if CD2/CD3 levels were below 20 cel/uL and platelet counts <50,000cells/mm3 on the day after the second dose.

    Reporting group title
    Basiliximab
    Reporting group description
    		 Historical cohort

    Reporting group values
    		 Anti-T Lymphocyte Globulin Basiliximab Total
    Number of subjects
    		 20 20 40
    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)
    		 60 ( 6 ) 57 ( 7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 3 5
        Male
    		 18 17 35

    End points

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    End points reporting groups
    Reporting group title
    Anti-T Lymphocyte Globulin
    Reporting group description
    		 ATG was intravenously (i.v.) administered on Intensive Care Unit (ICU) admission at a dose of 1mg/kg/ bodyweight. All patients were premedicated with methyl prednisolone 250mg i.v., dexchlorpheniramine 5mg i.v., and paracetamol 1g. Following doses were given on days 2 and 4 with dose adjustment according to CD2/CD3 levels (>20cel/uL). The third dose of ATG on day 4 was omitted if CD2/CD3 levels were below 20 cel/uL and platelet counts <50,000cells/mm3 on the day after the second dose.

    Reporting group title
    Basiliximab
    Reporting group description
    		 Historical cohort

    Primary: ACR episodes 7 days

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    End point title
    		 ACR episodes 7 days
    End point description
    Combination of absence of ACR (Acute Cellular Rejection) episodes and eGFR ≥ 60mL/min/1.73m2
    End point type
    Primary
    End point timeframe
    7 days after transplantation
    End point values
    		 Anti-T Lymphocyte Globulin Basiliximab
    Number of subjects analysed
    20
    20
    Units: percent
        number (not applicable)
    45
    40
    Statistical analysis title
    		 ACR 7 days
    Comparison groups
    Anti-T Lymphocyte Globulin v Basiliximab
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Primary: ACR episodes 1 month

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    End point title
    		 ACR episodes 1 month
    End point description
    Combination of absence of ACR (Acute Cellular Rejection) episodes and eGFR ≥ 60mL/min/1.73m2
    End point type
    Primary
    End point timeframe
    1 month after transplantation
    End point values
    		 Anti-T Lymphocyte Globulin Basiliximab
    Number of subjects analysed
    20
    20
    Units: percent
        number (not applicable)
    50
    55
    Statistical analysis title
    		 ACR 1 month
    Comparison groups
    Anti-T Lymphocyte Globulin v Basiliximab
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Renal function 1 month

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    End point title
    		 Renal function 1 month
    End point description
    Recovery of renal function as eGFR ≥60 mL/min/1.73m2
    End point type
    Secondary
    End point timeframe
    1 month after transplantation
    End point values
    		 Anti-T Lymphocyte Globulin Basiliximab
    Number of subjects analysed
    20
    20
    Units: percent
        number (not applicable)
    50
    55
    Statistical analysis title
    		 Renal function recovery
    Comparison groups
    Anti-T Lymphocyte Globulin v Basiliximab
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 > 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Renal function 1 year

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    End point title
    		 Renal function 1 year
    End point description
    End point type
    Secondary
    End point timeframe
    1 year after transplantation
    End point values
    		 Anti-T Lymphocyte Globulin Basiliximab
    Number of subjects analysed
    20
    20
    Units: ml/min/1.73m2
        arithmetic mean (standard deviation)
    58 ( 16 )
    62 ( 16 )
    Statistical analysis title
    		 Renal function 1 year
    Comparison groups
    Anti-T Lymphocyte Globulin v Basiliximab
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.31
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    One year
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12
    Reporting groups
    Reporting group title
    ATG group
    Reporting group description
    		 -

    Reporting group title
    BAS group
    Reporting group description
    		 -

    Serious adverse events
    		 ATG group BAS group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ATG group BAS group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 20 (30.00%)
    7 / 20 (35.00%)
    Immune system disorders
    Thrombocytopenia
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Thrombocytopenia and Leukopenia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Infections and infestations
    Cholangitis
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 20 (5.00%)
         occurrences all number
    3
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    MRSA
    Additional description: Methicillin-resistant Staphylococcus aureus infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1

    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.
    Low number of patients owing to the exploratory nature of the trial and bias in inclusion criteria. Patients with severe thrombocytopenia or leucopenia were not included in the ATG group. Prospective studies are required to confirm these results

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30186817
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