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    Clinical Trial Results:
    Prospective donor-specific Cellular alloresponse assessment for Immunosuppression Minimization in de novo renal transplantation

    Summary
    EudraCT number
    		 2014-001325-33
    Trial protocol
    		 DE   ES   CZ   NL  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jul 2022
    First version publication date
    09 Jul 2022
    Other versions
    Summary report(s)
    		 Preformed T cell alloimmunity and HLA eplet mismatch to guide immunosuppression minimization with tacrolimus monotherapy in kidney transplantation: Results of the CELLIMIN trial

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CELLIMIN
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02540395
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department Nephrology and BCRT, Charité Universitätsmedizin Berlin
    Sponsor organisation address
    Augustenburger Pl. 1, Berlin, Germany, 13353
    Public contact
    Project manager, Charité - Universitätsmedizin Berlin, +34 932607385, petra.reinke@charite.de
    Scientific contact
    Project manager, Charité - Universitätsmedizin Berlin, +34 932607385, petra.reinke@charite.de
    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
    Interim
    Date of interim/final analysis
    31 Oct 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study is to demonstrate the utility and safety of the IFN-? ELISPOT marker for the stratification of kidney transplant recipients into low and high IS regimens. The enrichment study will test non-inferiority of low IS regimen compared to high IS regimen, assuming 10% of BPAR at 6-months in the control group, and allowing a non-inferiority limit of maximum 15%.
    Protection of trial subjects
    An external Data Safety Monitoring Board (DSMB) was responsible for periodic safety review and guided by predetermined protocol–defined stopping criteria.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2015
    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
    Netherlands: 42
    Country: Number of subjects enrolled
    Spain: 52
    Country: Number of subjects enrolled
    Czechia: 19
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 50
    Worldwide total number of subjects
    167
    EEA total number of subjects
    167
    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)
    167
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Low immunological risk subjects were eligible to participate if >18 years of age and receiving a primary single kidney transplant. Enrolment was targeted to 673 patients, with 302 E− transplant patients randomized to low or SOC immunosuppression. the trial was terminated when 167 were recruited. In all, 101 patients were randomized and followed

    Pre-assignment
    Screening details
    		 All subjects freely gave written informed consent prior to participation, including informed consent for the screening procedures to establish subject eligibility. Screened Patients: 186 Screening failure: 19 (10 Invalid ELISPOT; 1 Pre transplant DSA; 1 Early graft loss; 7 Consent withdrawal)

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 E−/SOC Group
    Arm description
    		 Standard of care immunosuppression (SOC)
    Arm type
    		 Experimental

    Investigational medicinal product name
    TACROLIMUS
    Investigational medicinal product code
    Tacrolimus
    Other name
    Tacrolimus
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Based on current standard of care therapy consisting in TAC to achieve a 4–8ng/ml plasma trough levels.

    Investigational medicinal product name
    mycophenolate mofetil
    Investigational medicinal product code
    mycophenolate mofetil
    Other name
    MYCOPHENOLATE MOFETIL
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    mycophenolate mofetil (MMF) initially 1gr bid and subsequently adjusted according to the subjects tolerance.

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Prednisolone
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intraarticular use, Intramuscular use, Oral use
    Dosage and administration details
    500 mg methylprednisolone perioperatively to continue with oral prednisone (20 mg/day the first 2 weeks and tapered not less than 5 mg/day at 4 weeks posttransplant).

    Arm title
    		 E−/LI Group
    Arm description
    		 Low immunosuppression (LI)
    Arm type
    		 Experimental

    Investigational medicinal product name
    TACROLIMUS
    Investigational medicinal product code
    Tacrolimus
    Other name
    Tacrolimus
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Based on TAC monotherapy to achieve TAC 8–10 ng/ml plasma trough levels during the first 4 weeks and 6–8ng/ml thereafter.

    Investigational medicinal product name
    mycophenolate mofetil
    Investigational medicinal product code
    mycophenolate mofetil
    Other name
    MYCOPHENOLATE MOFETIL
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    MMF (1 g bid) during the first week

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Prednisolone
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intraarticular use, Intramuscular use, Oral use
    Dosage and administration details
    500 mg methylprednisolone perioperatively to continue with oral prednisone 20 mg/day the first 2 weeks and tapered to 5 mg/day from month 1 to month 2 when finally discontinued.

    Arm title
    		 E+ Group
    Arm description
    		 Group II. ELISPOT positive (E+) transplant candidates received the same current standard of care immunosuppressive regimen than group E−/SOC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TACROLIMUS
    Investigational medicinal product code
    Tacrolimus
    Other name
    Tacrolimus
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Based on current standard of care therapy consisting in TAC to achieve a 4–8ng/ml plasma trough levels.

    Investigational medicinal product name
    mycophenolate mofetil
    Investigational medicinal product code
    mycophenolate mofetil
    Other name
    MYCOPHENOLATE MOFETIL
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    mycophenolate mofetil (MMF) initially 1gr bid and subsequently adjusted according to the subjects tolerance.

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Prednisolone
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intraarticular use, Intramuscular use, Oral use
    Dosage and administration details
    500 mg methylprednisolone perioperatively to continue with oral prednisone (20 mg/day the first 2 weeks and tapered not less than 5 mg/day at 4 weeks posttransplant).

    Number of subjects in period 1
    		E−/SOC Group E−/LI Group E+ Group
    Started
    53
    48
    66
    Completed
    41
    35
    55
    Not completed
    12
    13
    11
         rATG
    1
    -
    -
         Belatacept
    1
    -
    -
         TAC/mTori
    -
    -
    8
         MMF withdrawal
    2
    -
    -
         CsA
    4
    -
    -
         triple therapy
    -
    2
    -
         TAC+ steroids
    -
    5
    -
         rescue therapy for sc-BPAR
    -
    3
    -
         Lost to follow-up
    2
    2
    3
         mTORI
    1
    -
    -
         low TAC levels
    -
    1
    -
         Protocol deviation
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    E−/SOC Group
    Reporting group description
    		 Standard of care immunosuppression (SOC)

    Reporting group title
    E−/LI Group
    Reporting group description
    		 Low immunosuppression (LI)

    Reporting group title
    E+ Group
    Reporting group description
    		 Group II. ELISPOT positive (E+) transplant candidates received the same current standard of care immunosuppressive regimen than group E−/SOC.

    Reporting group values
    		 E−/SOC Group E−/LI Group E+ Group Total
    Number of subjects
    		 53 48 66 167
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.51 ( 12.81 ) 54.68 ( 14.11 ) 53.88 ( 13.97 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12 16 19 47
        Male
    		 41 32 46 119
        N/A
    		 0 0 1 1
    Recipient ethnicity
    Units: Subjects
        Caucasian
    		 50 45 46 141
        No Caucasian
    		 3 3 1 7
        N/A
    		 0 0 19 19
    Cause of end-stage renal disease
    Units: Subjects
        Glomerulonephritis
    		 10 15 17 42
        Vascular
    		 3 3 8 14
        Diabetes Mellitus
    		 12 4 7 23
        Polycystic kidney disease
    		 12 10 13 35
        Unknown
    		 9 10 15 34
        Others
    		 7 5 5 17
        N/A
    		 0 1 1 2
    Time on dialysis (months)
    Units: monthths
        arithmetic mean (standard deviation)
    		 41.20 ( 50.44 ) 34.50 ( 51.06 ) 23.06 ( 28.30 ) -
    Baseline Panel Reactive Antibodies
    Units: Levels
        arithmetic mean (standard deviation)
    		 0.45 ( 2.43 ) 0 ( 0 ) 0.23 ( 1.14 ) -
    HLA allelic MM
    Units: Count?
        arithmetic mean (standard deviation)
    		 5.58 ( 2.59 ) 6.77 ( 1.77 ) 7.24 ( 2.30 ) -
    HLA Class I
    Units: Count
        arithmetic mean (standard deviation)
    		 3.57 ( 1.69 ) 4.33 ( 1.19 ) 4.24 ( 1.59 ) -
    HLA Class II
    Units: Count
        arithmetic mean (standard deviation)
    		 2.02 ( 1.29 ) 2.44 ( 1.09 ) 3.00 ( 1.07 ) -
    Pretransplant donor-specific IFN-γ ELISpots
    Units: Count
        arithmetic mean (standard deviation)
    		 7.75 ( 6.82 ) 7.67 ( 7.03 ) 80.02 ( 83.14 ) -

    End points

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    End points reporting groups
    Reporting group title
    E−/SOC Group
    Reporting group description
    		 Standard of care immunosuppression (SOC)

    Reporting group title
    E−/LI Group
    Reporting group description
    		 Low immunosuppression (LI)

    Reporting group title
    E+ Group
    Reporting group description
    		 Group II. ELISPOT positive (E+) transplant candidates received the same current standard of care immunosuppressive regimen than group E−/SOC.

    Subject analysis set title
    E+ with low eplet risk
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Donor/recipient HLA DQ eplet MM risk score for clinical and subclinical BPAR between study groups

    Subject analysis set title
    E+ with high risk
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Donor/recipient HLA DQ eplet MM risk score for clinical and subclinical BPAR between study groups

    Subject analysis set title
    E-/SOC low eplet risk
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Donor/recipient HLA DQ eplet MM risk score for clinical and subclinical BPAR between study groups

    Subject analysis set title
    E-/SOC high risk
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Donor/recipient HLA DQ eplet MM risk score for clinical and subclinical BPAR between study groups

    Subject analysis set title
    E-/LI low risk
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Donor/recipient HLA DQ eplet MM risk score for clinical and subclinical BPAR between study groups.

    Subject analysis set title
    E-/LI high risk
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Donor/recipient HLA DQ eplet MM risk score for clinical and subclinical BPAR between study groups.

    Primary: Evaluation of the BPAR between E-/Soc vs E-/LI

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    End point title
    		 Evaluation of the BPAR between E-/Soc vs E-/LI
    End point description
    BPAR, biopsy-proven acute rejection; BL, borderline lesions;
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 E−/SOC Group E−/LI Group E+ Group
    Number of subjects analysed
    43
    35
    55
    Units: Subjects
        BPAR (excluding BL)
    1
    4
    12
    Attachments
    		 BPAR between the study groups in all patients
    Statistical analysis title
    		 The time-dependent association of BPAR
    Statistical analysis description
    Since the primary study endpoint could not be achieved, a number of clinically relevant outcomes were analyzed as a post-hoc analysis.
    Comparison groups
    E−/SOC Group v E−/LI Group
    Number of subjects included in analysis
    78
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05 [1]
    Method
    		 Logrank
    Confidence interval
    Notes
    [1] - excluding BL lesions, showed no statistically significant differences between groups (1/43 [2%] vs. 4/35 [13%], p = .16, respectively)

    Primary: Evaluation BPAR ITT

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    End point title
    		 Evaluation BPAR ITT
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 E−/SOC Group E−/LI Group E+ Group
    Number of subjects analysed
    53
    48
    66
    Units: Subjects
        6-mo BPAR
    5
    11
    12
    Statistical analysis title
    		 BPAR ITT after six months
    Comparison groups
    E−/SOC Group v E−/LI Group v E+ Group
    Number of subjects included in analysis
    167
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Logrank
    Confidence interval

    Secondary: eGFR progression

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    End point title
    		 eGFR progression
    End point description
    Twelve-month eGFR progression between study groups in all patients (intention to treat)
    End point type
    Secondary
    End point timeframe
    untill 12 months
    End point values
    		 E−/SOC Group E−/LI Group E+ Group
    Number of subjects analysed
    53
    48
    66
    Units: ml/min
    arithmetic mean (standard deviation)
        at 15 days
    40.88 ( 19.88 )
    42.26 ( 16.36 )
    38.21 ( 17.74 )
        at 1 month
    47.66 ( 18.71 )
    43.46 ( 15.69 )
    42.93 ( 14.70 )
        at 2 months
    48.72 ( 19.98 )
    42.62 ( 15.51 )
    46.00 ( 13.79 )
        at 3 months
    49.95 ( 22.27 )
    39.97 ( 16.41 )
    47.20 ( 13.03 )
        at 6 months
    53.95 ( 21.16 )
    45.31 ( 15.44 )
    4991 ( 14.41 )
        at 12 months
    55.44 ( 18.21 )
    46.25 ( 13.29 )
    51.36 ( 15.81 )
    Attachments
    		 eGFR over 12 months
    No statistical analyses for this end point

    Secondary: De novo DSA at 12 months

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    End point title
    		 De novo DSA at 12 months
    End point description
    dnDSA, de novo donor-specific antibodies; At 12 months, 149 (89%) patients were tested for anti-HLA antibodies; 47 (88%) among E−/SOC, 43 (89%) within E−/LI and 59(89%) among E+ patients (Table S4). In all, 17 dnDSA were detected among 11 (7.4%) patients, 6 class I (3 anti-A and 3 anti-B), and 11 class II (7 anti-DQ and 4 anti-DR). no differences were observed regarding total dnDSA between the three groups, E+ patients displayed higher class-II dnDSA than the other groups.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 E−/SOC Group E−/LI Group E+ Group
    Number of subjects analysed
    47
    43
    53
    Units: Subjects
        Total dnDSA
    1
    3
    7
        Class-I dnDSA
    1
    3
    2
        Class-II dnDSA
    0
    1
    7
    No statistical analyses for this end point

    Secondary: Incidence of clinical and subclinical BPAR

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    End point title
    		 Incidence of clinical and subclinical BPAR
    End point description
    When E+ patients were also analyzed, at 6 months, E+ showed significantly higher BPAR (both with and without BL lesions) than E−/SOC patients. Similarly, at 12 months, BPAR rates were significantly higher within E+ and E−/LI patients as compared to E−/SOC, especially in patients remaining on protocol. 12-month cumulative BPAR between the three groups showed the same differences both when assessed PP or ITT (Figure 2C-D). Likewise clinical BPAR, both E+ and E−/LI groups developed significantly higher incidence of sc-BPAR than E−/SOC.
    End point type
    Secondary
    End point timeframe
    Baseline to 12 months
    End point values
    		 E−/SOC Group E−/LI Group E+ Group
    Number of subjects analysed
    53
    48
    66
    Units: Subjects
        6-mo BPAR
    5
    11
    12
        12-mo BPAR
    6
    12
    13
        Sc-BPAR
    1
    10
    6
        Sc-BL
    4
    4
    2
    No statistical analyses for this end point

    Secondary: HLA eplet mismatching and de novo alloimmune activation

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    End point title
    		 HLA eplet mismatching and de novo alloimmune activation
    End point description
    We next assessed the impact of donor/recipient HLAMatchmaker eplet mismatches on main immune-mediated events between the distinct study groups. Similar to HLA allele mismatches, E− patients showed lower eplet mismatches as compared to E+
    End point type
    Secondary
    End point timeframe
    From Baseline to 12 months
    End point values
    		 E−/SOC Group E−/LI Group E+ Group
    Number of subjects analysed
    53
    48
    66
    Units: Mismatch
    arithmetic mean (standard deviation)
        Global HLA Eplet MM
    28.24 ( 17.10 )
    33.33 ( 11.81 )
    36.15 ( 15.19 )
        HLA class I eplet MM
    12.94 ( 7.56 )
    16.0 ( 5.84 )
    15.62 ( 7.12 )
        HLA class II eplet MM
    15.30 ( 11.81 )
    17.33 ( 10.30 )
    20.54 ( 10.93 )
        HLA class II eplet MM: DRB1
    7.83 ( 6.20 )
    8.50 ( 5.32 )
    9.87 ( 5.44 )
        HLA class II eplet MM: DQB1
    5.64 ( 5.53 )
    6.69 ( 5.33 )
    8.07 ( 5.43 )
        HLA class II eplet MM:DQA1
    1.83 ( 1.95 )
    2.15 ( 1.99 )
    2.59 ( 1.98 )
        HLA class II eplet MM: DQ(A1+B1)
    7.47 ( 6.73 )
    8.83 ( 6.37 )
    10.67 ( 6.73 )
    No statistical analyses for this end point

    Secondary: HLA DQ eplet MM risk score for clinical BPAR between study groups

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    End point title
    		 HLA DQ eplet MM risk score for clinical BPAR between study groups
    End point description
    Mean class-II eplet mismatches (MM) (DRB1+DQ), and particularly at DQ locus, were significantly higher in patients developing BPAR than in those that did not.However, these differences were only observed among the two E− study groups. A threshold o f DQ ( A1/B1) e plet m ismatches ≥10 defined high eplet risk for BPAR with the highest accuracy within all E−patients. See attachment for more details: Donor/recipient HLA DQ eplet MM risk score
    End point type
    Secondary
    End point timeframe
    Baseline to 12months
    End point values
    		 E+ with low eplet risk E+ with high risk E-/SOC low eplet risk E-/SOC high risk E-/LI low risk E-/LI high risk
    Number of subjects analysed
    28
    38
    28
    25
    28
    20
    Units: Subjects
        at risk
    6
    7
    1
    5
    4
    8
    Attachments
    		 Donor/recipient HLA DQ eplet MM risk score
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Adverse event reporting additional description
    Please see publication
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 own
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Total cohort
    Reporting group description
    		 No distinguish between the Groups

    Serious adverse events
    		 Total cohort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    60 / 167 (35.93%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    Cardiac disorders
    Angina Pectoris
    Additional description: Requires inpatient hospitalisation or prolongation of existing hospitalisation
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    atrial fibrillation
    Additional description: Requires inpatient hospitalisation or prolongation of existing hospitalisation
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    cardiac decompensation
    Additional description: Requires inpatient hospitalisation or prolongation of existing hospitalisation
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    cardiogenic shock
    Additional description: Requires inpatient hospitalisation or prolongation of existing hospitalisation
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoe déffort
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    mitralvalveinsufficiency
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    NSTEMI
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    "Pulmonar thromboembolism suspected"
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    CVP Syndrome with cerebral filiae
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General disorders and administration site conditions
    Acute febrile illness
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    death
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    sudden death
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Immune system disorders
    Acute rejection grade IIA
    Additional description: Requires inpatient hospitalisation or prolongation of existing hospitalisation
         subjects affected / exposed
    3 / 167 (1.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Acute vascular rejection IB in graft
    Additional description: Requires inpatient hospitalisation or prolongation of existing hospitalisation
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    abdominal wall hermatoma
    Additional description: Requires inpatient hospitalisation or prolongation of existing hospitalisation
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxemic lung failure
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Bronchitis
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    accute cellular rejection type
    Additional description: Requires inpatient hospitalisation or prolongation of existing hospitalisation
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute T-cell mediated rejection type I
    Additional description: other medically important conditions
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute tubular necrosis,
    Additional description: Requires inpatient hospitalisation or prolongation of existing hospitalisation
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    allograft dysfunction
    Additional description: Requires inpatient hospitalisation or prolongation of existing hospitalisation
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    acute on chronic renal failure due to rec. UTI
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    delayed graft function
         subjects affected / exposed
    3 / 167 (1.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Perirenal haematoma
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    renal transplant dysfunction
         subjects affected / exposed
    3 / 167 (1.80%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Ureteral stenosis
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    lymphocele
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Anxious
    Additional description: Requires inpatient hospitalisation or prolongation of existing hospitalisation
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Acute pyelonephritis
    Additional description: Requires inpatient hospitalisation or prolongation of existing hospitalisation
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bacteriemia due to Pseudomonas
    Additional description: Requires inpatient hospitalisation or prolongation of existing hospitalisation
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    urinary tract infection
         subjects affected / exposed
    15 / 167 (8.98%)
         occurrences causally related to treatment / all
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    urological sepsis
         subjects affected / exposed
    5 / 167 (2.99%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Infection with staphilococcus species (shunt)
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    CMV
         subjects affected / exposed
    4 / 167 (2.40%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory infections
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    spondylodiscitis
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Total cohort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    100 / 167 (59.88%)
    Surgical and medical procedures
    AVF shunt
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    General disorders and administration site conditions
    progressive pain left jaw and ear
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    A cold
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    3
    AF/GGT elevated
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Agitated
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    2
    alopecia
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    aque
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    2
    belly pain
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Diarrhea
         subjects affected / exposed
    33 / 167 (19.76%)
         occurrences all number
    45
    common cold
         subjects affected / exposed
    13 / 167 (7.78%)
         occurrences all number
    21
    dizziness
         subjects affected / exposed
    12 / 167 (7.19%)
         occurrences all number
    14
    Headache
         subjects affected / exposed
    11 / 167 (6.59%)
         occurrences all number
    13
    Immune system disorders
    Afunctio of kidney graft
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Afunctio of kidney graft
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Acute catarrh
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Back pain radiating out to stomach
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Psychiatric disorders
    A bit down
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    2
    Anxiety
         subjects affected / exposed
    3 / 167 (1.80%)
         occurrences all number
    3
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Arteria carotis externa stenosis right
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Arteria femoralis superior stenosis bilateral
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Arterial fibrillation
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    2
    atheromatosis
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Atrium fibrillation
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Bradycardia
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    2
    cardiac arrhythmia
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    cardiac decompensation
         subjects affected / exposed
    6 / 167 (3.59%)
         occurrences all number
    6
    Chest tightness and pain
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    2
    congestive heart failure
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    "Decompensation of secondary hypertension"
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    2
    dilitated aorta
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    2
    Dyslipidemia
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Dyspnoea NYHA II-III
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    2
    Edema
    Additional description: Edma foot and hand
         subjects affected / exposed
    24 / 167 (14.37%)
         occurrences all number
    37
    fast heartbeat
    Additional description: heartpalpitations or exercise
         subjects affected / exposed
    9 / 167 (5.39%)
         occurrences all number
    9
    Hemangioma abdominal
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Hepatomegaly
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    hypertensions
         subjects affected / exposed
    51 / 167 (30.54%)
         occurrences all number
    56
    Hypotension
         subjects affected / exposed
    5 / 167 (2.99%)
         occurrences all number
    5
    Nervous system disorders
    aphonia
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Benign paroxysmal positional vertigo
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Trembling, tremor
         subjects affected / exposed
    10 / 167 (5.99%)
         occurrences all number
    11
    Blood and lymphatic system disorders
    albuminurie
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    2
    Anemia
         subjects affected / exposed
    8 / 167 (4.79%)
         occurrences all number
    12
    hypercalcemia
         subjects affected / exposed
    7 / 167 (4.19%)
         occurrences all number
    7
    Leucopenia
         subjects affected / exposed
    13 / 167 (7.78%)
         occurrences all number
    15
    Gastrointestinal disorders
    abdominal pain, cramps, discomfort
         subjects affected / exposed
    13 / 167 (7.78%)
         occurrences all number
    15
    Air in colon
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Anal fissure
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Aerobilia
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    constipation and obstipation
         subjects affected / exposed
    31 / 167 (18.56%)
         occurrences all number
    31
    Nausea
         subjects affected / exposed
    10 / 167 (5.99%)
         occurrences all number
    11
    Vomiting
         subjects affected / exposed
    7 / 167 (4.19%)
         occurrences all number
    8
    fever
         subjects affected / exposed
    18 / 167 (10.78%)
         occurrences all number
    23
    Skin and subcutaneous tissue disorders
    Acne on scalp
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    acne medicemtosa/acneiforme
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Acrovesiculeus eczema,
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Actinic keratosis
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    2
    bad scarring
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Basal cell cardinoma
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    2
    BENIGN SKIN LESSION IN NOSE
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Renal and urinary disorders
    acute renal failure
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    2
    Acute tublar necrosis
         subjects affected / exposed
    3 / 167 (1.80%)
         occurrences all number
    3
    Alguria
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    acute rejection grad III
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    anuria
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Asymptomatic urinary tract infection
         subjects affected / exposed
    3 / 167 (1.80%)
         occurrences all number
    3
    AVF after biopsy in kidney graft
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    achilles tendon complaints
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences all number
    3
    Back Pain
         subjects affected / exposed
    9 / 167 (5.39%)
         occurrences all number
    11
    Baker's cyst right popliteal fossa,
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Biceps rupture
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Bilateral myopathy gluteal muscles
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Infections and infestations
    Aspergillus nidulans (bronchial lavage)
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences all number
    1
    Bact, Infection
         subjects affected / exposed
    4 / 167 (2.40%)
         occurrences all number
    11
    Unary infections
         subjects affected / exposed
    9 / 167 (5.39%)
         occurrences all number
    19
    BK Virus Infections
         subjects affected / exposed
    13 / 167 (7.78%)
         occurrences all number
    16
    CM Virus
         subjects affected / exposed
    14 / 167 (8.38%)
         occurrences all number
    14
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    3 / 167 (1.80%)
         occurrences all number
    3
    Hypercalcemia
         subjects affected / exposed
    23 / 167 (13.77%)
         occurrences all number
    33
    metabolic disorders
         subjects affected / exposed
    13 / 167 (7.78%)
         occurrences all number
    13

    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.
    A main limitation of the CELLIMIN trial was its premature termination due to insufficient recruitment rates, which illustrates the complexity of conducting large, prospective randomized trials using novel biomarkers.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33725408
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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
    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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