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    Clinical Trial Results:
    Anti-donor alloreactivity-guided CNI minimization versus unguided standard triple therapy in living-donor kidney transplantation

    Summary
    EudraCT number
    		 2015-002465-28
    Trial protocol
    		 DE  
    Global end of trial date
    05 Feb 2021

    Results information
    Results version number
    		 v1
    This version publication date
    18 Jun 2022
    First version publication date
    18 Jun 2022
    Other versions
    		 v2
    Summary report(s)
    		 ICANMINI Final Study report

    Trial information

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    Trial identification
    Sponsor protocol code
    ICANMINI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LMU Klinikum - Koordinationszentrum Chirurgische Studien - AVT-KliniK
    Sponsor organisation address
    Marchioninistr. 15, Munich, Germany, 81377
    Public contact
    KCS Chirurgie, Klinik für Allgemeine-, Viszeral-, und Transplantationschirurgie, Klinikum der Universität München, +49 894400-0, michael.eder@med.uni-muenchen.de
    Scientific contact
    KCS Chirurgie, Klinik für Allgemeine-, Viszeral-, und Transplantationschirurgie, Klinikum der Universität München, 9440076573 894400-0, michael.eder@med.uni-muenchen.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
    Final
    Date of interim/final analysis
    31 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Feb 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Feb 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of an anti-donor alloreactivity guided CNI minimization on the evolution of renal function
    Protection of trial subjects
    In principle, the Safety population should include all patients who had taken at least one dose of the study medication. Yet, patients not treated, not treated for certain or patients with no observation after first intake of study medication were excluded from the safety evaluation. Excluding patients with no observation after the first intake from the safety population serves the purpose of consumer protection, as their exclusion leads to higher percentages of adverse events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 May 2016
    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
    Germany: 35
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    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)
    35
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Due to difficulties in study conduct and recruitment, further enhanced by the pandemic situation with COVIUD-19, it was decided to stop recruitment prematurely on 20-APR-2020. Already included patients remained in the follow up until their regular 12 months visit. The study end then occurred with the last patient last visit (LPLV) on 05-FEB-2021.

    Pre-assignment
    Screening details
    		 Between 23-May-2016(First Patient First Visit: Pat # 001) and 14-JAN-2020 (Last Patient First Visit: Pat. # 035) a total of 35 patients were included into the study (Table 4). The first 28 Patients were recruited under the contract with Astellas and the last patient (pat. #28) included 26-Feb-2019 within this contract. Pat 29 (included 19-Mar-2019

    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
    		 Reference
    Arm description
    		 Unguided standard triple therapy with prolonged-release tacrolimus, EC mycophenolic acid (720 mg b.i.d.) and steroids. Tacrolimus target trough levels 8-12 ng/ml 0-w4, 8-12 ng/ml w5-w12; 6-8 ng/ml w13-m12
    Arm type
    		 unguided

    Investigational medicinal product name
    tacrolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    Tacrolimus target trough levels 8-12 ng/ml 0-w4, 6-8 ng/ml w5-w12; 4-6 ng/ml w13-m12

    Arm title
    		 Investigational
    Arm description
    		 Anti-donor alloreactivity-guided CNI minimization with prolonged-release tacrolimus, EC mycophenolic acid (720 mg b.i.d.) and steroids. Tacrolimus target trough levels 8-12 ng/ml 0-w4, 6-8 ng/ml w5-w12; 4-6 ng/ml w13-m12
    Arm type
    		 guided

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Reference Investigational
    Started
    14
    21
    Completed
    14
    21

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Reference
    Reporting group description
    		 Unguided standard triple therapy with prolonged-release tacrolimus, EC mycophenolic acid (720 mg b.i.d.) and steroids. Tacrolimus target trough levels 8-12 ng/ml 0-w4, 8-12 ng/ml w5-w12; 6-8 ng/ml w13-m12

    Reporting group title
    Investigational
    Reporting group description
    		 Anti-donor alloreactivity-guided CNI minimization with prolonged-release tacrolimus, EC mycophenolic acid (720 mg b.i.d.) and steroids. Tacrolimus target trough levels 8-12 ng/ml 0-w4, 6-8 ng/ml w5-w12; 4-6 ng/ml w13-m12

    Reporting group values
    		 Reference Investigational Total
    Number of subjects
    		 14 21 35
    Age categorical
    Male or female subjects ≥ 18 years of age. Subjects must be recipients of a primary renal transplant from a living unrelated, living related non-human leukocyte antigen identical donor
    Units: Subjects
        only Adults
    		 14 21 35
    Gender categorical
    Units: Subjects
        Female
    		 3 11 14
        Male
    		 11 10 21

    End points

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    End points reporting groups
    Reporting group title
    Reference
    Reporting group description
    		 Unguided standard triple therapy with prolonged-release tacrolimus, EC mycophenolic acid (720 mg b.i.d.) and steroids. Tacrolimus target trough levels 8-12 ng/ml 0-w4, 8-12 ng/ml w5-w12; 6-8 ng/ml w13-m12

    Reporting group title
    Investigational
    Reporting group description
    		 Anti-donor alloreactivity-guided CNI minimization with prolonged-release tacrolimus, EC mycophenolic acid (720 mg b.i.d.) and steroids. Tacrolimus target trough levels 8-12 ng/ml 0-w4, 6-8 ng/ml w5-w12; 4-6 ng/ml w13-m12

    Primary: Primary Endpoint

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    End point title
    		 Primary Endpoint
    End point description
    eGFR (MDRD-4) [ml/min/1.73 m2] IM (immune monitored) UC (unguided control) N 21 14 Mean ± SD 52.6±16.9 60.7±12.7 Median (Q1-Q3) 53.9 (43.1-60.4) 58.5 (50.2-66.0) P=0.1524 (Wilcoxon rank sum test)
    End point type
    Primary
    End point timeframe
    The primary endpoint was defined as eGFR calculated according to the 4 variable MDRD formula at 12 months after transplantation. The result shows a numerically lower eGFR in the immune monitored group but no statistically significant difference. The resul
    End point values
    		 Reference Investigational
    Number of subjects analysed
    14 [1]
    21 [2]
    Units: 35
        eGFR
    14
    21
    Notes
    [1] - 60,7
    [2] - 52
    Statistical analysis title
    		 Primary Efficacy Criterion
    Statistical analysis description
    Among various measures of renal function, the MDRD-4 formula has been selected for the primary endpoint. The parameter to be tested will therefore be the eGFR calculated by the MDRD-4 formula at 12 months after transplantation. The 4-variable MDRD formula estimates GFR using the four variables: serum creatinine, age, ethnicity, and gender (Version 2000 [10]): eGFR12M (ml/min/1.73 m2) = 186 * Serum Creatinine (mg/dl)-1.154 * age-0.203 * [1.210 if black] * [0.742 if female] (Creatinine level
    Comparison groups
    Reference v Investigational
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.05 [4]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Cox proportional hazard
    Point estimate
    95
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 95
    Variability estimate
    Standard deviation
    Dispersion value
    0.8881
    Notes
    [3] - The statistical analysis was planned after completion of the trial, which is when all patients had completed their follow up phase. This final analysis therefore includes all efficacy and safety data until end of study. Statistical analysis is based on the final statistical analysis plan, dated 07-FEB-2022 which is available in the appendix. If p values are calculated in the area of explorative analysis, they should be presented explicitly without referring to hypotheses or a significance leve
    [4] - The confirmatory analysis is based on the ITT population. A detailed analysis plan is given in the Study Protocol amendment 1, dated MMM DD, YYYY and elaborated with the final statistical analysis plan dated 30-JAN-2019. The primary analysis had bee

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First Patient First Visit: 23-May-2016 Last Patient Last Visit: 05-Feb-2021
    Adverse event reporting additional description
    A qualified physician associated with the study will be available to assess clinical signs and symptoms that may be indicative of an adverse event. All physical examination findings, vital sign abnormalities, and clinical laboratory abnormalities will be captured as AEs when deemed medically significant by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    unguided
    Reporting group description
    		 -

    Reporting group title
    IM group
    Reporting group description
    		 -

    Serious adverse events
    		 unguided IM group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (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
    		 unguided IM group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 11 (27.27%)
    8 / 12 (66.67%)
    Blood and lymphatic system disorders
    After bleeding
    Additional description: Injury, poisoning and procedural complications 1 18 After bleeding 11/04/18 1 3-Severe Not related to study drug Post procedural haemorrhage UC
         subjects affected / exposed [1]
    3 / 3 (100.00%)
    8 / 8 (100.00%)
         occurrences all number
    65
    146
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: unknown

    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.
    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
    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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