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    Clinical Trial Results:
    A Long-term, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of a Modigraf® based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

    Summary
    EudraCT number
    		 2022-002351-19
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    14 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Sep 2024
    First version publication date
    25 Sep 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    F506-CL-0406
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05153915
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Chinese Clinical Trial Registry: CTR20212679
    Sponsors
    Sponsor organisation name
    Astellas Pharma China, Inc.
    Sponsor organisation address
    No.3 Jia 6 Road 10, Shenyang City, China,
    Public contact
    Astellas Pharma China, Inc., Clinical Trial Transparency, +86 (0)10-85216666, astellas.resultsdisclosure@astellas.com
    Scientific contact
    Astellas Pharma China, Inc., Clinical Trial Transparency, +86 (0)10-85216666, astellas.resultsdisclosure@astellas.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Mar 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients.
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of Protected Health Information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Dec 2021
    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
    China: 56
    Worldwide total number of subjects
    56
    EEA total number of subjects
    0
    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)
    13
    Children (2-11 years)
    22
    Adolescents (12-17 years)
    21
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Chinese pediatric participants who had de novo allograft liver or kidney transplantation were enrolled in the study.

    Pre-assignment
    Screening details
    		 Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Liver transplant
    Arm description
    		 Pediatric participants who underwent de novo allograft liver transplantation received initial daily dose of 0.15 to 0.3 milligram per kilogram (mg/kg) of body weight oral suspension of tacrolimus granules post-operatively for 12 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tacrolimus
    Investigational medicinal product code
    Other name
    Modigraf
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received oral suspension of tacrolimus granules.

    Arm title
    		 Kidney transplant
    Arm description
    		 Pediatric participants who underwent de novo allograft kidney transplantation received initial daily dose of 0.15 to 0.3 mg/kg of body weight oral suspension of tacrolimus granules post-operatively for 12 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tacrolimus
    Investigational medicinal product code
    Other name
    Modigraf
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received oral suspension of tacrolimus granules.

    Number of subjects in period 1
    		Liver transplant Kidney transplant
    Started
    20
    36
    Safety Analysis (SAF)
    20
    35
    Completed
    18
    28
    Not completed
    2
    8
         Consent withdrawn by subject
    1
    3
         Adverse event, non-fatal
    1
    4
         Enrolled, but not treated
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Liver transplant
    Reporting group description
    		 Pediatric participants who underwent de novo allograft liver transplantation received initial daily dose of 0.15 to 0.3 milligram per kilogram (mg/kg) of body weight oral suspension of tacrolimus granules post-operatively for 12 months.

    Reporting group title
    Kidney transplant
    Reporting group description
    		 Pediatric participants who underwent de novo allograft kidney transplantation received initial daily dose of 0.15 to 0.3 mg/kg of body weight oral suspension of tacrolimus granules post-operatively for 12 months.

    Reporting group values
    		 Liver transplant Kidney transplant Total
    Number of subjects
    		 20 36 56
    Age Categorical
    Units: participants
        Infants and toddlers (28 days-23 months)
    		 13 0 13
        Children (2-11 years)
    		 6 16 22
        Adolescents (12-17 years)
    		 1 20 21
    Gender Categorical
    Units: participants
        Female
    		 8 12 20
        Male
    		 12 24 36
    Race
    Units: Subjects
        Asian
    		 20 36 56

    End points

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    End points reporting groups
    Reporting group title
    Liver transplant
    Reporting group description
    		 Pediatric participants who underwent de novo allograft liver transplantation received initial daily dose of 0.15 to 0.3 milligram per kilogram (mg/kg) of body weight oral suspension of tacrolimus granules post-operatively for 12 months.

    Reporting group title
    Kidney transplant
    Reporting group description
    		 Pediatric participants who underwent de novo allograft kidney transplantation received initial daily dose of 0.15 to 0.3 mg/kg of body weight oral suspension of tacrolimus granules post-operatively for 12 months.

    Primary: Percentage of Participants With Acute Rejection (AR)

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    End point title
    		 Percentage of Participants With Acute Rejection (AR) [1]
    End point description
    AR is an immune response against the donor graft that causes tissue impairment and potential failure. The criteria for rejection was performed by the local histopathologist following the “Histological Grading of Liver Biopsies for Rejection”, the “Banff diagnostic categories for renal allograft biopsies”. The Full Analysis Set (FAS) consisted of all participants who took at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    From first dose to month 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: Per protocol, statistical analysis was not planned for this endpoint.
    End point values
    		 Liver transplant Kidney transplant
    Number of subjects analysed
    20
    35
    Units: Percentage of participants
        number (confidence interval 95%)
    20.0 (5.7 to 43.7)
    5.7 (0.7 to 19.2)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Biopsy-Proven Acute Rejections (BPAR)

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    End point title
    		 Percentage of Participants With Biopsy-Proven Acute Rejections (BPAR) [2]
    End point description
    AR is an immune response against the donor graft that causes tissue impairment and potential failure. The criteria for rejection was performed by the local histopathologist following the “Histological Grading of Liver Biopsies for Rejection”, the “Banff diagnostic categories for renal allograft biopsies”. A BPAR episode was defined as any AR episode confirmed by biopsy. FAS population.
    End point type
    Primary
    End point timeframe
    From first dose to month 12
    Notes
    [2] - 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: Per protocol, statistical analysis was not planned for this endpoint.
    End point values
    		 Liver transplant Kidney transplant
    Number of subjects analysed
    20
    35
    Units: Percentage of participants
        number (confidence interval 95%)
    15.0 (3.2 to 37.9)
    2.9 (0.1 to 14.9)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Clinically Suspected Rejection

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    End point title
    		 Percentage of Participants With Clinically Suspected Rejection [3]
    End point description
    AR is an immune response against the donor graft that causes tissue impairment and potential failure. The criteria for rejection was performed by the local histopathologist following the “Histological Grading of Liver Biopsies for Rejection”, the “Banff diagnostic categories for renal allograft biopsies”. An AR was clinically suspected in participants who experienced an increase in serum creatinine, after the exclusion of other causes of graft dysfunction (generally with biopsy). FAS population.
    End point type
    Primary
    End point timeframe
    From first dose to month 12
    Notes
    [3] - 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: Per protocol, statistical analysis was not planned for this endpoint.
    End point values
    		 Liver transplant Kidney transplant
    Number of subjects analysed
    20
    35
    Units: Percentage of participants
        number (confidence interval 95%)
    5.0 (0.1 to 24.9)
    2.9 (0.1 to 14.9)
    No statistical analyses for this end point

    Primary: Number of Participants who Died

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    End point title
    		 Number of Participants who Died [4]
    End point description
    Number of participant who died was recorded during 12 months’ post-transplant; any cause of death was taken into account. FAS population.
    End point type
    Primary
    End point timeframe
    From first dose to month 12
    Notes
    [4] - 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: Per protocol, statistical analysis was not planned for this endpoint.
    End point values
    		 Liver transplant Kidney transplant
    Number of subjects analysed
    20
    35
    Units: Participants
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Primary: Number of Dose Adjustments Throughout the Study Period

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    End point title
    		 Number of Dose Adjustments Throughout the Study Period [5]
    End point description
    The dose adjustments required for the organ transplant were reported. The Safety Analysis Set (SAF) consisted of all participants who took at least one dose of study drug. SAF population with available data were reported.
    End point type
    Primary
    End point timeframe
    From first dose to month 12
    Notes
    [5] - 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: Per protocol, statistical analysis was not planned for this endpoint.
    End point values
    		 Liver transplant Kidney transplant
    Number of subjects analysed
    19
    33
    Units: dose adjustments
        arithmetic mean (standard deviation)
    11.6 ( 5.2 )
    13.3 ( 5.2 )
    No statistical analyses for this end point

    Primary: Number of Participant with Graft Failure

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    End point title
    		 Number of Participant with Graft Failure [6]
    End point description
    Graft failure was defined as graft dysfunction, including re-transplantation, graft loss or death, during the study period. A graft dysfunction to permanent dialysis in kidney transplantation was also considered as graft failure. FAS population with available data were reported.
    End point type
    Primary
    End point timeframe
    From first dose to month 12
    Notes
    [6] - 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: Per protocol, statistical analysis was not planned for this endpoint.
    End point values
    		 Liver transplant Kidney transplant
    Number of subjects analysed
    20
    35
    Units: Participants
        number (not applicable)
    0
    2
    No statistical analyses for this end point

    Primary: Number of Participants with Treatment Emergent Adverse Events (AEs)

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    End point title
    		 Number of Participants with Treatment Emergent Adverse Events (AEs) [7]
    End point description
    An AE is defined as any untoward medical occurrence in a participant given an study drug not necessarily linked to this treatment. An AE can be any unfavorable and unintended sign (e.g., abnormal laboratory finding; abnormal laboratory test result or other safety assessment, symptom, or disease temporally associated with the use of study drug whether or not considered related to the study drug. Treatment emergent adverse event (TEAE) is defined as AE observed after administering the study drug. SAF population.
    End point type
    Primary
    End point timeframe
    From first dose to month 12
    Notes
    [7] - 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: Per protocol, statistical analysis was not planned for this endpoint.
    End point values
    		 Liver transplant Kidney transplant
    Number of subjects analysed
    20
    35
    Units: Participants
        number (not applicable)
    18
    35
    No statistical analyses for this end point

    Primary: Whole Blood Trough Levels of Tacrolimus

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    End point title
    		 Whole Blood Trough Levels of Tacrolimus [8]
    End point description
    Tacrolimus whole blood trough levels were routinely monitored from whole blood samples, using a local assay method, for example EMITÒ or Liquid-Chromatography-Mass-Spectrometry-Mass-Spectrometry (LC-MS-MS) in the local laboratories. Mean trough levels of tacrolimus from month 1 through month 12 has been reported. SAF population.
    End point type
    Primary
    End point timeframe
    From month 1 through month 12 (predose)
    Notes
    [8] - 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: Per protocol, statistical analysis was not planned for this endpoint.
    End point values
    		 Liver transplant Kidney transplant
    Number of subjects analysed
    20
    35
    Units: nanograms per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    7.09 ( 2.28 )
    8.26 ( 1.47 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose to month 12
    Adverse event reporting additional description
    SAF population
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    v26.0
    Reporting groups
    Reporting group title
    Kidney Transplant
    Reporting group description
    		 Pediatric participants who underwent de novo allograft kidney transplantation received initial daily dose of 0.15 to 0.3 mg/kg of body weight oral suspension of tacrolimus granules post-operatively for 12 months.

    Reporting group title
    Liver Transplant
    Reporting group description
    		 Pediatric participants who underwent de novo allograft liver transplantation received initial daily dose of 0.15 to 0.3 mg/kg of body weight oral suspension of tacrolimus granules post-operatively for 12 months.

    Serious adverse events
    		 Kidney Transplant Liver Transplant
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 35 (54.29%)
    10 / 20 (50.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Donor specific antibody present
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Post transplant lymphoproliferative disorder
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Delayed graft function
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complications of transplanted kidney
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complications of transplant surgery
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (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
    Posterior reversible encephalopathy syndrome
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Impaired healing
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (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 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingivitis ulcerative
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venoocclusive liver disease
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal vein thrombosis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery thrombosis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoporosis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (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
    Bacterial infection
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 35 (2.86%)
    4 / 20 (20.00%)
         occurrences causally related to treatment / all
    0 / 1
    4 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 20 (15.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Kidney Transplant Liver Transplant
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 35 (100.00%)
    17 / 20 (85.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Post transplant lymphoproliferative disorder
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 35 (8.57%)
    7 / 20 (35.00%)
         occurrences all number
    4
    19
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Pneumothorax
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Hypocapnia
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Atelectasis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Investigations
    BK polyomavirus test positive
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 20 (0.00%)
         occurrences all number
    5
    0
    Blood albumin decreased
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 20 (5.00%)
         occurrences all number
    2
    2
    Blood bilirubin increased
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Blood urea increased
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Lymphocyte count decreased
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    7
    0
    Lymphocyte count increased
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Mycoplasma test positive
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    5
    0
    Neutrophil count increased
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Platelet count decreased
         subjects affected / exposed
    3 / 35 (8.57%)
    1 / 20 (5.00%)
         occurrences all number
    5
    1
    Procalcitonin increased
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Protein urine present
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 20 (0.00%)
         occurrences all number
    4
    0
    SARS-CoV-2 test positive
         subjects affected / exposed
    1 / 35 (2.86%)
    4 / 20 (20.00%)
         occurrences all number
    1
    4
    Transaminases increased
         subjects affected / exposed
    5 / 35 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    6
    0
    Urine leukocyte esterase positive
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 20 (0.00%)
         occurrences all number
    6
    0
    White blood cell count decreased
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    7
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Cardiac disorders
    Cardiac failure acute
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Hypoglobulinaemia
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Anaemia
         subjects affected / exposed
    4 / 35 (11.43%)
    5 / 20 (25.00%)
         occurrences all number
    4
    6
    Thrombocytopenia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Neutropenia
         subjects affected / exposed
    5 / 35 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    5
    0
    Leukopenia
         subjects affected / exposed
    14 / 35 (40.00%)
    0 / 20 (0.00%)
         occurrences all number
    21
    0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Abdominal pain
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Constipation
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    7 / 35 (20.00%)
    5 / 20 (25.00%)
         occurrences all number
    8
    6
    Vomiting
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    6
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Intestinal obstruction
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Hepatobiliary disorders
    Liver injury
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Hepatobiliary disease
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Hepatic function abnormal
         subjects affected / exposed
    2 / 35 (5.71%)
    4 / 20 (20.00%)
         occurrences all number
    2
    8
    Hepatic artery thrombosis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Dermatitis allergic
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Eczema asteatotic
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 20 (0.00%)
         occurrences all number
    4
    0
    Proteinuria
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 20 (0.00%)
         occurrences all number
    4
    0
    Endocrine disorders
    Hyperparathyroidism
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Bacterial infection
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    BK virus infection
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 35 (2.86%)
    7 / 20 (35.00%)
         occurrences all number
    1
    9
    Epstein-Barr virus infection
         subjects affected / exposed
    1 / 35 (2.86%)
    10 / 20 (50.00%)
         occurrences all number
    1
    16
    Exanthema subitum
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 20 (10.00%)
         occurrences all number
    3
    2
    Pneumonia
         subjects affected / exposed
    1 / 35 (2.86%)
    4 / 20 (20.00%)
         occurrences all number
    1
    4
    Post procedural infection
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Tonsillitis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 35 (20.00%)
    2 / 20 (10.00%)
         occurrences all number
    12
    3
    Urinary tract infection
         subjects affected / exposed
    14 / 35 (40.00%)
    0 / 20 (0.00%)
         occurrences all number
    14
    0
    Metabolism and nutrition disorders
    Hypoproteinaemia
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 20 (0.00%)
         occurrences all number
    5
    0
    Hypophosphataemia
         subjects affected / exposed
    5 / 35 (14.29%)
    0 / 20 (0.00%)
         occurrences all number
    8
    0
    Hyponatraemia
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Hypomagnesaemia
         subjects affected / exposed
    6 / 35 (17.14%)
    1 / 20 (5.00%)
         occurrences all number
    7
    1
    Hypokalaemia
         subjects affected / exposed
    10 / 35 (28.57%)
    0 / 20 (0.00%)
         occurrences all number
    10
    0
    Hypoglycaemia
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Hypochloraemia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Hypocalcaemia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Hyperuricaemia
         subjects affected / exposed
    19 / 35 (54.29%)
    0 / 20 (0.00%)
         occurrences all number
    31
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Hyperphosphataemia
         subjects affected / exposed
    6 / 35 (17.14%)
    0 / 20 (0.00%)
         occurrences all number
    13
    0
    Hyperlipidaemia
         subjects affected / exposed
    16 / 35 (45.71%)
    0 / 20 (0.00%)
         occurrences all number
    19
    0
    Hyperkalaemia
         subjects affected / exposed
    10 / 35 (28.57%)
    0 / 20 (0.00%)
         occurrences all number
    20
    0
    Hypercalcaemia
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Hyperglycaemia
         subjects affected / exposed
    8 / 35 (22.86%)
    0 / 20 (0.00%)
         occurrences all number
    10
    0
    Vitamin D deficiency
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Metabolic acidosis
         subjects affected / exposed
    8 / 35 (22.86%)
    0 / 20 (0.00%)
         occurrences all number
    10
    0
    Lactose intolerance
         subjects affected / exposed
    0 / 35 (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? Yes
    Date
    Amendment
    17 Dec 2020
    The sample size was reduced for acceptable precision. An inclusion criterion was added as advised by authority. The exclusion criteria were updated based on the advice from Key Opinion Leaders (KOLs). The proportion of bilateral kidney transplantation was very small, and there was higher risk of post-operative complications. Same for the participants with a low body weight and severe primary diseases. The safety endpoints were added as the study was aiming to accumulate safety and efficacy data from the very first Chinese pediatric patients who receive Modigraf. Other administrative changes were made.

    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 reported
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    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
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