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    Clinical Trial Results:
    A prospective, observational long-term follow-up trial of kidney transplant patients treated with imlifidase or plasma exchange after an active/chronic active antibody-mediated rejection episode

    Summary
    EudraCT number
    		 2020-004777-49
    Trial protocol
    		 FR   AT   DE  
    Global end of trial date
    30 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Mar 2025
    First version publication date
    12 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20-HMedIdeS-18
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04711850
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hansa Biopharma AB
    Sponsor organisation address
    Scheelevägen 22, Lund, Sweden, 223 63
    Public contact
    Clinical Operation Department, Hansa Biopharma AB, +46 046165670, info@hansabiopharma.com
    Scientific contact
    Clinical Operation Department, Hansa Biopharma AB, +46 046165670, info@hansabiopharma.com
    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
    22 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Mar 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Mar 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to evaluate kidney graft survival in subjects that have been treated with imlifidase or plasma exchange in association with AMR in trial 16-HMedIdeS-12 (referred to as the feeder trial).
    Protection of trial subjects
    No treatment was administered during this follow-up study. Administration of imlifidase was done during the feeder trial 16-HMedIdeS-12. Details of the goals of the research and the risk and benefits of the trial protocol were reviewed with each potential trial subject. Physicians expert in the care of patients with AMR were responsible for the patients' care at each site.
    Background therapy
    		 N/A this is a long-term follow-up study.
    Evidence for comparator
    		 N/A this is a long-term follow-up study.
    Actual start date of recruitment
    20 Jan 2021
    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
    France: 10
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Austria: 4
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    15
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited between 20-JAN-2021 and 11-NOV-2022

    Pre-assignment
    Screening details
    		 All 18 patients who were screened were enrolled in the trial.

    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
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Imlifidase
    Arm description
    		 Patients in this arm received imlifidase in the feeder study 16-HMedIdeS-12
    Arm type
    		 Experimental

    Investigational medicinal product name
    Imlifidase
    Investigational medicinal product code
    Other name
    IdeS, IgG endopeptidase
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Imlifidase was not administered in this long-term follow-up trial. Subjects randomized to imlifidase treatment in the feeder study 16-HMedIdeS-12 received one intravenous dose of imlifidase, 0.25 mg/kg, administered over 15 minutes.

    Arm title
    		 PLEX
    Arm description
    		 Subjects randomized to plasma exchange (PLEX) treatment in the feeder study 16-HMedIdes-12 received 5-10 sessions of PLEX, as judged by the investigator. Immunoadsorption (IA) could replace PE, at the discretion of the investigator.
    Arm type
    		 PLEX

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Imlifidase PLEX
    Started
    11
    7
    Completed
    3
    1
    Not completed
    8
    6
         Patient not eligible - no AMR in feeder study
    1
    -
         Graft loss
    2
    1
         Sponsor decision
    -
    2
         Trial terminated by Sponsor
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Imlifidase
    Reporting group description
    		 Patients in this arm received imlifidase in the feeder study 16-HMedIdeS-12

    Reporting group title
    PLEX
    Reporting group description
    		 Subjects randomized to plasma exchange (PLEX) treatment in the feeder study 16-HMedIdes-12 received 5-10 sessions of PLEX, as judged by the investigator. Immunoadsorption (IA) could replace PE, at the discretion of the investigator.

    Reporting group values
    		 Imlifidase PLEX Total
    Number of subjects
    		 11 7 18
    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)
    		 8 7 15
        From 65-84 years
    		 3 0 3
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.9 ( 17.6 ) 48.0 ( 13.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 4 9
        Male
    		 6 3 9
    BMI
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.1 ( 6.9 ) 29.0 ( 7.1 ) -

    End points

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    End points reporting groups
    Reporting group title
    Imlifidase
    Reporting group description
    		 Patients in this arm received imlifidase in the feeder study 16-HMedIdeS-12

    Reporting group title
    PLEX
    Reporting group description
    		 Subjects randomized to plasma exchange (PLEX) treatment in the feeder study 16-HMedIdes-12 received 5-10 sessions of PLEX, as judged by the investigator. Immunoadsorption (IA) could replace PE, at the discretion of the investigator.

    Primary: Overall graft survival at Year 3

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    End point title
    		 Overall graft survival at Year 3 [1]
    End point description
    Graft survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to graft loss. Graft loss is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy.
    End point type
    Primary
    End point timeframe
    Three (3) years after start of AMR treatment in feeder trial 16-HMedIdeS-12.
    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: Due to early termination of the study a large proportion of patients were censored.
    End point values
    		 Imlifidase PLEX
    Number of subjects analysed
    11 [2]
    7 [3]
    Units: Patients
        Patients
    9
    6
    Notes
    [2] - Due to the early termination of the trial a large proportion of patients were censored prior to Y3.
    [3] - Due to the early termination of the trial a large proportion of patients were censored prior to Y3.
    No statistical analyses for this end point

    Secondary: Overall graft survival at Year 1 and Year 2

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    End point title
    		 Overall graft survival at Year 1 and Year 2
    End point description
    Graft survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to graft loss. Graft loss is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy.
    End point type
    Secondary
    End point timeframe
    Up to 2 years after start of AMR treatment in the feeder trial (16-HMedIdes-12).
    End point values
    		 Imlifidase PLEX
    Number of subjects analysed
    11 [4]
    7 [5]
    Units: Patients
        Patients with functioning graft Year 1
    9
    6
        Patients with functioning graft Year 2
    9
    6
    Notes
    [4] - Due to the early termination of the trial a large proportion of patients were censored prior to Y2.
    [5] - Due to the early termination of the trial a large proportion of patients were censored prior to Y2.
    No statistical analyses for this end point

    Secondary: Patient survival at Year 3

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    End point title
    		 Patient survival at Year 3
    End point description
    Overall patient survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to death for any cause.
    End point type
    Secondary
    End point timeframe
    Up to 3 years after start of AMR treatment in the feeder study (16-HMedIdeS-12).
    End point values
    		 Imlifidase PLEX
    Number of subjects analysed
    11 [6]
    7 [7]
    Units: Patients
        Patients alive Year 3
    11
    7
    Notes
    [6] - Due to the early termination of the trial a large proportion of patients were censored prior to Y3.
    [7] - Due to the early termination of the trial a large proportion of patients were censored prior to Y3.
    No statistical analyses for this end point

    Secondary: Kidney function as evaluated by eGFR

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    End point title
    		 Kidney function as evaluated by eGFR
    End point description
    Estimated glomerular filtration rate (eGFR) was calculated as described by the Modification of Diet in Renal Disease Study (MDRD) equation. eGFR is a measure of kidney function. eGFR for a kidney with normal function is 90 mL/min/1.72m2. Kidney disease is characterised by a decreased eGFR value.
    End point type
    Secondary
    End point timeframe
    Up to 3 years after start of AMR treatment in the feeder study (16-HMedIdes-12)
    End point values
    		 Imlifidase PLEX
    Number of subjects analysed
    11 [8]
    7 [9]
    Units: mL/min/1.73m2
    arithmetic mean (standard deviation)
        Year 1
    30.1 ( 20.9 )
    36.6 ( 12.3 )
        Year 2
    41.2 ( 6.4 )
    39.7 ( 0 )
        Year 3
    30.5 ( 0 )
    0 ( 0 )
    Notes
    [8] - 8 patients Y1, 3 patients Y2, 1 patient Y3 due to early termination of trial.
    [9] - 4 patients Y1, 1 patient Y2, 0 patients Y3 due to early termination of trial.
    No statistical analyses for this end point

    Secondary: Kidney function as evaluated by creatinine

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    End point title
    		 Kidney function as evaluated by creatinine
    End point description
    The creatinine in blood is a measure of kidney function. Kidney disease is characterized by an increased creatinine level.
    End point type
    Secondary
    End point timeframe
    Up to 3 years after start of AMR treatment in the feeder study (16-HMedIdes-12).
    End point values
    		 Imlifidase PLEX
    Number of subjects analysed
    11 [10]
    7 [11]
    Units: micromole(s)/litre
    arithmetic mean (full range (min-max))
        Year 1
    297 (81 to 795)
    187 (102 to 288)
        Year 2
    130 (107 to 161)
    187 (187 to 187)
        Year 3
    144 (144 to 144)
    0 (0 to 0)
    Notes
    [10] - 8 patients Y1, 3 patients Y2, 1 patient Y3 due to early termination of trial.
    [11] - 4 patients Y1, 1 patient Y2, 0 patients Y3 due to early termination of trial.
    No statistical analyses for this end point

    Secondary: AMR episodes (presumed or biopsy proven)

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    End point title
    		 AMR episodes (presumed or biopsy proven)
    End point description
    Information about AMR episodes was collected according to Banff 2017 or later classification. For-cause biopsies together with contemporaneous local donor specific antibodies (DSA) analyses, kidney function parameters (creatinine, albumin/creatinine ratio in urine) and treatments (e.g. plasma exchange and IVIg) were collected to assess the rejection episodes.
    End point type
    Secondary
    End point timeframe
    Up to 3 years after start of AMR treatment in the feeder study (16-HMedIdeS-12).
    End point values
    		 Imlifidase PLEX
    Number of subjects analysed
    11 [12]
    7 [13]
    Units: Patients
        Patients with AMR episodes
    9
    6
    Notes
    [12] - Due to early termination of the trial a large proportion of patients were censored prior to Y3.
    [13] - Due to early termination of the trial a large proportion of patients were censored prior to Y3.
    No statistical analyses for this end point

    Secondary: Rejection episodes other than AMR (presumed or biopsy proven)

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    End point title
    		 Rejection episodes other than AMR (presumed or biopsy proven)
    End point description
    Information about rejection episodes were collected according to Banff 2017 or later classification. For-cause biopsies together with contemporaneous local donor specific antibodies (DSA) analyses, kidney function parameters (creatinine, albumin/creatinine ratio in urine) and treatments (e.g. plasma exchange and IVIg) were collected to assess the rejection episodes.
    End point type
    Secondary
    End point timeframe
    Up to 3 years after AMR treatment in the feeder study (16-HMedIdeS-12).
    End point values
    		 Imlifidase PLEX
    Number of subjects analysed
    11 [14]
    7 [15]
    Units: Patients
        Patients with rejection episodes other than AMR
    3
    4
    Notes
    [14] - Due to early termination of the trial a large proportion of patients were censored prior to Y3.
    [15] - Due to early termination of the trial a large proportion of patients were censored prior to Y3.
    No statistical analyses for this end point

    Secondary: Levels of donor specific antibodies (DSA)

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    End point title
    		 Levels of donor specific antibodies (DSA)
    End point description
    DSA levels were measured using single antigen bead human leukocyte antigen (SAB-HLA) assay.
    End point type
    Secondary
    End point timeframe
    Up to 3 years after start of AMR treatment in the feeder study (16-HMedIdeS-12).
    End point values
    		 Imlifidase PLEX
    Number of subjects analysed
    11 [16]
    7 [17]
    Units: MFI level
    arithmetic mean (standard deviation)
        Pre-treatment in feeder study (Visit 2)
    10764 ( 7603 )
    15794 ( 5897 )
        Year 1
    5964 ( 5539 )
    3672 ( 643 )
        Year 2
    2156 ( 1025 )
    12362 ( 0 )
        Year 3
    974 ( 0 )
    0 ( 0 )
    Notes
    [16] - 10 pre-dose in 16-HMedIdeS-12, 8 patients Y1, 3 patients Y2, 1 patient Y3 due to early termination
    [17] - 5 pre-dose in 16-HMedIdeS-12, 2 patients Y1, 1 patients Y2, 0 patients Y3 due to early termination
    No statistical analyses for this end point

    Secondary: Levels of anti-drug IgG antibodies

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    End point title
    		 Levels of anti-drug IgG antibodies [18]
    End point description
    The immunogenicity of imlifidase was assessed by measuring ADA levels. Only patients exposed to imlifidase were assessed for ADA.
    End point type
    Secondary
    End point timeframe
    Up to 3 years after start of AMR treatment in the feeder study (16-HMedIdeS-12).
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The patients in the PLEX arm were not exposed to imlifidase. Hence N/A to measure ADA for this group.
    End point values
    		 Imlifidase
    Number of subjects analysed
    11 [19]
    Units: mg/L
    geometric mean (geometric coefficient of variation)
        Year 1
    75 ( 405 )
        Year 2
    41 ( 1426 )
        Year 3
    15 ( 0 )
    Notes
    [19] - 8 patients at Y1, 3 patients at Y2, 1 patient at Y3 due to early termination of the trial
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From inclusion until end of study (Year 3).
    Adverse event reporting additional description
    Only AEs related to trial procedure or related to IMP administered in feeder trial were to be collected.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Imlifidase treatment in the feeder study (16-HMedIdeS-12)
    Reporting group description
    		 All patients treated with imlifidase in the feeder study 16-HMedIdes-12. No treatment was administered in this long-term follow-up trial.

    Reporting group title
    PLEX treatment in the feeder study (16-HMedIdeS-12)
    Reporting group description
    		 All patients treated with PLEX in the feeder study. No treatment was administered in this long-term follow-up study.

    Serious adverse events
    		 Imlifidase treatment in the feeder study (16-HMedIdeS-12) PLEX treatment in the feeder study (16-HMedIdeS-12)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Imlifidase treatment in the feeder study (16-HMedIdeS-12) PLEX treatment in the feeder study (16-HMedIdeS-12)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    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: Only AEs related to trial procedure or related to IMP administered in feeder trial were to be collected. No such events were reported.

    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.
    Early termination leading to small number of subjects analysed.
    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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