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    Clinical Trial Results:
    EFFICACY OF THE NEW TACROLIMUS ONCE-DAILY DOSE LCTP (ENVARSUS®) FORMULATION TO PREVENT HYPERGLYCAEMIA AFTER KIDNEY TRANSPLANTATION IN AT-RISK PATIENTS: A RANDOMISED, CONTROLLED, OPEN-LABEL PILOT STUDY.

    Summary
    EudraCT number
    		 2017-000718-52
    Trial protocol
    		 ES  
    Global end of trial date
    26 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Aug 2024
    First version publication date
    10 Aug 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DMPT-17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hospital Universitario de Canarias
    Sponsor organisation address
    Ofra s/n, La Laguna, Spain, 38320
    Public contact
    Esteban Porrini, Hospital Universitario de Canarias. FIISC: Fundación Instituto Investigación de Canarias., 34 92267 8118, estebanlporrini@gmail.com
    Scientific contact
    Armando Torres, FIISC: Fundación Instituto Investigación de Canarias. Universidad de La Laguna. , +34 92267 8118, atorresram@gmail.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 May 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate whether de novo immunosuppression with the extended-release formulation of Tacrolimus®, Envarsus®, reduces the incidence of post-transplant diabetes mellitus (PTDM), defined by fasting blood glucose, after oral glucose tolerance test (OGTT) or by the use of antidiabetic drugs, compared to the standard formulation of Tacrolimus® (Prograf®), in patients at high risk of post-transplant diabetes. INCLUSION CRITERIA - 18 years or older were eligible to participate. - One of the following "metabolic criteria" must be met inter alia: a) Age ≥ 60 years or b) age < 60 years and one of these two risk factors: - Glucose intolerance (glycemia after 120min of a standard OGTT ≥140 and <200 mg/dl) - Metabolic syndrome (3 criteria): Impaired fasting glucose (100-125 mg/dl); Body Mass Index (BMI) ≥28 kg/m2; BP (>140/90, or on antihypertensive medication); Triglycerides ≥150 mg/dl; HDL cholesterol <40 mg/dl in men and <50 mg/dl in women.
    Protection of trial subjects
    This is a Phase-IV clinical trial and all participants received standard of care to minimize pain and stress. In addition, all patients participating in this clinical trial have been covered by the contracted Insurance Policy.
    Background therapy
    		 Mycophenolate mofetil (MMF) or Mycophenolic Acid Corticosteroids (methylprednisolone; prednisone) Induction therapy: Basiliximab (anti-CD25 antibody) or Thymoglobulin (depending on donor/recipient characteristics). Treatment to prevent early glucotoxicity: I.V.Insulin. Treatment of acute humoral rejection: plasmapheresis, immunoglobulins, and rituximab, alone or in combination. Drugs to prevent the most common infections: Pneumocystis jirovecii (cotrimoxazol) and cytomegalovirus (gancyclovir and valgancyclovir). Medications for dyslipidemia: statins or ezetimibe.
    Evidence for comparator
    		 Tacrolimus use in patients with pre-transplant risk factors such as metabolic syndrome and insulin resistance increases the risk of PTDM. The pharmacokinetics of different formulations of tacrolimus (immediate release: Prograf; sustained release: Advagraf; and the new once-daily meltdose-technology formulation LCTP-Envarsus®) have recently been compared. The LCTP formulation delays (Tmax) and reduces peak exposure (17% reduction in Cmax) and increases biodisponibility compared to Prograf and Advagraf without affecting overall exposure. This "flatter" pharmacokinetic profile of LCTP-Envarsus® compared to the other tacrolimus formulations may have clinical relevance if it is shown to result in less pancreatic beta-cell toxicity and thus a lower incidence of PTDM. In other words, there is sufficient evidence to support the hypothesis that patients at high risk of PTDM may benefit from tacrolimus pharmacokinetics with lower peak (Cmax) exposure as provided by the LCTP formulation. This may translate into a significant reduction in glycemia and glycotoxicity and ultimately the incidence of PTDM in the first three months post-transplant compared to other tacrolimus formulations.
    Actual start date of recruitment
    30 Aug 2017
    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
    Spain: 62
    Worldwide total number of subjects
    62
    EEA total number of subjects
    62
    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)
    31
    From 65 to 84 years
    31
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 62 patients were randomized during the study period and 52 completed the study (27 in the Prograf arm and 25 in the Envarsus arm). According to the planned withdrawal criteria, 3 patients in the Prograf group and 7 in the Envarsus group were excluded (p=0.3).

    Pre-assignment
    Screening details
    		 There was no pre-assignment period

    Period 1
    Period 1 title
    Number of subjects in period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IR-TAC (PROGRAF)
    Arm description
    		 Arm 1: Prograf divided into two doses. On the day of transplantation, a single dose was administered before surgery. This is the standard clinical practice of the HUC Nephrology Department.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PROGRAF
    Investigational medicinal product code
    Other name
    Tacrolimus monohydrate
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Arm 1: Prograf 0.1 mg/kg/day divided into two doses to maintain tacrolimus levels between 8-12 ng/ml for the first month and 6-10ng/ml until the third month. Before of transplantation, a single dose of 0.05 mg/kg or 0.10 mg/kg was administered before surgery, depending on whether the donor met the expanded criteria or not. This is the standard clinical practice of the HUC Nephrology Department.

    Investigational medicinal product name
    Mycophenolate mofetil (MMF)
    Investigational medicinal product code
    Other name
    Micofenolato mofetil (MMF)
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Mycophenolate mofetil (MMF) 2 g/day or mycophenolic acid (EC-MFA) 1.44 g/day for the first month post-transplant. From day 31 MMF or EC-MA will be reduced to 1 g/day or 720 mg/day, respectively.

    Investigational medicinal product name
    methylprednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Corticosteroids at reduced exposure: 0.25 g methylprednisolone intraoperatively and 60 mg on post-transplant day 1

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Corticosteroids at reduced exposure: Prednisone 0.3 mg/Kg/day (never >20 mg/day) until post-transplant day 14, 0. 2 mg/kg/day from day 15 to 28 (never >15 mg/day), 0.15 mg/kg/day from day 29 to 35 (never >10 mg/day), 0.1 mg/kg/day (never >7.5 mg/day) from day 36 to 42, and then 5 mg/day until 3 months.

    Arm title
    		 LCTP (ENVARSUS)
    Arm description
    		 Arm 2: Envarsus® as a single daily dose starting within 24 hours after transplantation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ENVARSUS
    Investigational medicinal product code
    Other name
    Sustained-release tacrolimus
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Arm 2: Envarsus® 0.1 mg/kg/day as a single daily dose starting within 24 hours after transplantation to maintain tacrolimus levels of 8-12 ng/ml for the first month and 6-10 ng/ml until 3 months.

    Investigational medicinal product name
    Mycophenolate mofetil (MMF)
    Investigational medicinal product code
    Other name
    Micofenolato mofetil (MMF)
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Mycophenolate mofetil (MMF) 2 g/day or mycophenolic acid (EC-MA) 1.44 g/day for the first month post-transplant. From day 31 MMF or EC-MA will be reduced to 1 g/day or 720 mg/day, respectively.

    Investigational medicinal product name
    Methylprednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Corticosteroids at reduced exposure: 0.25 g methylprednisolone intraoperatively, 60 mg on post-transplant day 1

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Corticosteroids at reduced exposure: From day 2 posttransplant prednisone 0.3 mg/Kg/day (never >20 mg/day) until post-transplant day 14, 0. 2 mg/kg/day from day 15 to 28 (never >15 mg/day), 0.15 mg/kg/day from day 29 to 35 (never >10 mg/day), 0.1 mg/kg/day (never >7.5 mg/day) from day 36 to 42, and then 5 mg/day until 3 months.

    Number of subjects in period 1
    		IR-TAC (PROGRAF) LCTP (ENVARSUS)
    Started
    30
    32
    Completed
    27
    25
    Not completed
    3
    7
         Immunosuppresion change
    1
    -
         Randomized not transplanted
    1
    -
         Adverse event + immunosupression change
    -
    5
         Adverse event, non-fatal
    -
    2
         Refusal of final OGTT
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IR-TAC (PROGRAF)
    Reporting group description
    		 Arm 1: Prograf divided into two doses. On the day of transplantation, a single dose was administered before surgery. This is the standard clinical practice of the HUC Nephrology Department.

    Reporting group title
    LCTP (ENVARSUS)
    Reporting group description
    		 Arm 2: Envarsus® as a single daily dose starting within 24 hours after transplantation.

    Reporting group values
    		 IR-TAC (PROGRAF) LCTP (ENVARSUS) Total
    Number of subjects
    		 30 32 62
    Age categorical
    Units: Subjects
        Adults (18 years and over)
    		 30 32 62
    Age continuous
    Attending the arm assigned, the median age was: IR-TAC (PROGRAF) = 64.82 (50.20-68.41) LCTP (ENVARSUS) = 63.52 (46.53-69.66)
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 64.82 (51.3 to 68.8) 64.89 (50.9 to 70.4) -
    Gender categorical
    Units: Subjects
        Female
    		 11 9 20
        Male
    		 19 23 42
    Recipient's Sex
    Units: Subjects
        Male
    		 19 23 42
        Female
    		 11 9 20
    Race
    Percentage of Caucasians: IR-TAC (PROGRAF)= 96.3% LCTP (ENVARSUS)= 92%
    Units: Subjects
        Caucasian
    		 29 30 59
        Other
    		 1 2 3
    Donor's Sex
    Units: Subjects
        Male
    		 17 24 41
        Female
    		 13 8 21
    Family history of diabetes
    Defined as first-degree relatives with Diabetes Mellitus
    Units: Subjects
        Yes
    		 7 11 18
        No
    		 23 21 44
    Polycystic kidney disease
    Units: Subjects
        Yes
    		 5 8 13
        No
    		 25 24 49
    Peritoneal dialysis
    Units: Subjects
        Yes
    		 8 14 22
        No
    		 22 18 40
    Tobacco
    Units: Subjects
        Yes
    		 10 18 28
        No
    		 19 14 33
        Not recorded
    		 1 0 1
    Pre-transplantation statins
    Units: Subjects
        Yes
    		 21 20 41
        No
    		 9 12 21
    Donor's Cardiac Death
    Units: Subjects
        Yes
    		 9 7 16
        No
    		 21 25 46
    Recipient's Age
    Units: Years
        median (standard deviation)
    		 60.9 ( 12.4 ) 60.4 ( 12.2 ) -
    Donor's Age
    Units: Years
        arithmetic mean (standard deviation)
    		 57.9 ( 10.8 ) 58.2 ( 13.6 ) -
    BMI
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.9 ( 4.9 ) 26.1 ( 4 ) -
    Dialysis time
    Dialysis time measured in months
    Units: Months
        arithmetic mean (standard deviation)
    		 23.7 ( 13.8 ) 24.3 ( 21.6 ) -
    Total cholesterol
    Units: mg/dl
        arithmetic mean (standard deviation)
    		 152.8 ( 38.1 ) 158 ( 39.1 ) -
    HDL-cholesterol
    Units: mg/dl
        arithmetic mean (standard deviation)
    		 43.6 ( 13 ) 44.4 ( 10.7 ) -
    LDL-cholesterol
    Units: mg/dl
        arithmetic mean (standard deviation)
    		 82.9 ( 34.2 ) 81.2 ( 36.5 ) -
    Triglycerides
    Units: mg/dl
        arithmetic mean (standard deviation)
    		 153.4 ( 94.4 ) 149.2 ( 60.4 ) -
    Fasting Glucose (baseline)
    Units: mg/dl
        arithmetic mean (standard deviation)
    		 89.1 ( 13.3 ) 91.8 ( 10.1 ) -
    HbA1c: Glycosylated haemoglobin
    Units: Percentage
        arithmetic mean (standard deviation)
    		 5.2 ( 0.41 ) 5.2 ( 0.3 ) -
    Cold ischemia time
    Units: Hours
        median (inter-quartile range (Q1-Q3))
    		 -
    Subject analysis sets

    Subject analysis set title
    Final sample included in IR-TAC (PROGRAF) group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The initial per-protocol sample size was 30 patients for IR-TAC (PROGRAF). However, 27 were included in the final analysis due to the exclusion of 3 patients from this group.

    Subject analysis set title
    Final sample included in LCTP (ENVARSUS) group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The initial per-protocol sample size was 32 patients for LCTP (ENVARSUS). However, 25 patients were included in the final analysis due to the exclusion of 7 patients from this group.

    Subject analysis sets values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects
    27
    25
    Age categorical
    Units: Subjects
        Adults (18 years and over)
    27
    25
    Age continuous
    Attending the arm assigned, the median age was: IR-TAC (PROGRAF) = 64.82 (50.20-68.41) LCTP (ENVARSUS) = 63.52 (46.53-69.66)
    Units: years
        median (inter-quartile range (Q1-Q3))
    64.82 (50.20 to 68.41)
    63.52 (46.53 to 69.66)
    Gender categorical
    Units: Subjects
        Female
    10
    6
        Male
    17
    19
    Recipient's Sex
    Units: Subjects
        Male
    17
    19
        Female
    10
    6
    Race
    Percentage of Caucasians: IR-TAC (PROGRAF)= 96.3% LCTP (ENVARSUS)= 92%
    Units: Subjects
        Caucasian
    26
    23
        Other
    1
    2
    Donor's Sex
    Units: Subjects
        Male
    17
    20
        Female
    10
    5
    Family history of diabetes
    Defined as first-degree relatives with Diabetes Mellitus
    Units: Subjects
        Yes
    7
    9
        No
    17
    14
    Polycystic kidney disease
    Units: Subjects
        Yes
    5
    6
        No
    22
    19
    Peritoneal dialysis
    Units: Subjects
        Yes
    7
    12
        No
    19
    13
    Tobacco
    Units: Subjects
        Yes
    8
    13
        No
    18
    12
        Not recorded
    1
    0
    Pre-transplantation statins
    Units: Subjects
        Yes
    19
    17
        No
    7
    8
    Donor's Cardiac Death
    Units: Subjects
        Yes
    8
    6
        No
    19
    19
    Recipient's Age
    Units: Years
        median (standard deviation)
    59.9 ( 11.96 )
    58.4 ( 12.9 )
    Donor's Age
    Units: Years
        arithmetic mean (standard deviation)
    56.70 ( 10.67 )
    55.24 ( 13.40 )
    BMI
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    28.61 ( 4.43 )
    25.53 ( 4.19 )
    Dialysis time
    Dialysis time measured in months
    Units: Months
        arithmetic mean (standard deviation)
    24.39 ( 13.82 )
    23.60 ( 22.86 )
    Total cholesterol
    Units: mg/dl
        arithmetic mean (standard deviation)
    152.92 ( 38.84 )
    158.59 ( 37.27 )
    HDL-cholesterol
    Units: mg/dl
        arithmetic mean (standard deviation)
    43.62 ( 13.32 )
    44.10 ( 11.42 )
    LDL-cholesterol
    Units: mg/dl
        arithmetic mean (standard deviation)
    82.58 ( 35.11 )
    79.71 ( 33.31 )
    Triglycerides
    Units: mg/dl
        arithmetic mean (standard deviation)
    156.31 ( 95.06 )
    154.91 ( 62.07 )
    Fasting Glucose (baseline)
    Units: mg/dl
        arithmetic mean (standard deviation)
    90.30 ( 12.97 )
    90.13 ( 8.58 )
    HbA1c: Glycosylated haemoglobin
    Units: Percentage
        arithmetic mean (standard deviation)
    5.19 ( 0.41 )
    5.22 ( 0.29 )
    Cold ischemia time
    Units: Hours
        median (inter-quartile range (Q1-Q3))
    11.42 (6.54 to 18.67)
    10.12 (7.66 to 16.58)

    End points

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    End points reporting groups
    Reporting group title
    IR-TAC (PROGRAF)
    Reporting group description
    		 Arm 1: Prograf divided into two doses. On the day of transplantation, a single dose was administered before surgery. This is the standard clinical practice of the HUC Nephrology Department.

    Reporting group title
    LCTP (ENVARSUS)
    Reporting group description
    		 Arm 2: Envarsus® as a single daily dose starting within 24 hours after transplantation.

    Subject analysis set title
    Final sample included in IR-TAC (PROGRAF) group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The initial per-protocol sample size was 30 patients for IR-TAC (PROGRAF). However, 27 were included in the final analysis due to the exclusion of 3 patients from this group.

    Subject analysis set title
    Final sample included in LCTP (ENVARSUS) group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The initial per-protocol sample size was 32 patients for LCTP (ENVARSUS). However, 25 patients were included in the final analysis due to the exclusion of 7 patients from this group.

    Primary: Glucose Metabolic Alteration

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    End point title
    		 Glucose Metabolic Alteration
    End point description
    End point type
    Primary
    End point timeframe
    3 months post-trasplantation
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: Subjects
        Normal Glucose Tolerance
    11
    14
        Impared Fasting Glucose
    3
    1
        Impared Glucose Tolerance
    8
    4
        Post-Transplant Diabetes Mellitus
    5
    6
    Statistical analysis title
    		 Normal Glucose Tolerance - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.49
    Method
    		 Chi-squared
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.24
         upper limit
    		 0.59
    Statistical analysis title
    		 Normal Glucose Tolerance - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.49
    Method
    		 Chi-squared
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 0.73
    Statistical analysis title
    		 Impared Fasting Glucose - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.6
    Method
    		 Chi-squared
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 0.48
    Statistical analysis title
    		 Impared Fasting Glucose - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.6
    Method
    		 Chi-squared
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 0.34
    Statistical analysis title
    		 Impared Glucose Tolerance - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.33
    Method
    		 Chi-squared
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 0.28
    Statistical analysis title
    		 Impared Glucose Tolerance - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.33
    Method
    		 t-test, 2-sided
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.19
    Statistical analysis title
    		 PTDM- IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.7
    Method
    		 Chi-squared
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 0.37
    Statistical analysis title
    		 PTDM- LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.7
    Method
    		 Chi-squared
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.11
         upper limit
    		 0.43

    Primary: Post-transplant Oral Glucose Tolerance Test (OGTT)

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    End point title
    		 Post-transplant Oral Glucose Tolerance Test (OGTT)
    End point description
    Glucose Level (mg/dl) by oral glucose tolerance test at 3 months measured at 3 time points: t0 (baseline) t30 (30 minutes after OGTT) t120 (120 minutes after OGTT)
    End point type
    Primary
    End point timeframe
    3-month post-transplant
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: mg/dl
    median (inter-quartile range (Q1-Q3))
        Glycaemia t0
    95.50 (87.75 to 104.25)
    88 (78.50 to 96.25)
        Glycaemia t30
    157 (138 to 178.50)
    139 (123.50 to 155.75)
        Glycaemia t120
    130.50 (108.25 to 170.25)
    125.50 (100 to 196)
    Statistical analysis title
    		 Glycaemia t0 - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.24
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Glycaemia t0 - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.24
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Glycaemia t30 - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.02
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Glycaemia t30 - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.02
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Glycaemia t120 - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.53
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Glycaemia t120 - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.53
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Insulinemia

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    End point title
    		 Insulinemia
    End point description
    Insulin levels (mcU/ml) at 3 months post-transplant OGTT measured at 3 time points: t0 (baseline) t30 (30 minutes after OGTT) t120 (30 minutes after OGTT)
    End point type
    Primary
    End point timeframe
    3 months post-transplant
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: mcU/ml
    median (inter-quartile range (Q1-Q3))
        Insulinemia t0
    7.95 (5.25 to 10.43)
    6.90 (5.05 to 10)
        Insulinemia t30
    25.35 (13.95 to 41.23)
    23.70 (8.45 to 47.23)
        Insulinemia t120
    32.35 (11.03 to 45.58)
    27.90 (3.80 to 44.73)
    Statistical analysis title
    		 Insulinemia t0 - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.84
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Insulinemia t0 - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.84
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Insulinemia t30 - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.67
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Insulinemia t30 - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.67
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Insulinemia t120 - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.32
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Insulinemia t120 - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.32
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: ISI- Insulin Sensitivity Index

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    End point title
    		 ISI- Insulin Sensitivity Index
    End point description
    3-month post-transplant Insulin Sensitivity Index
    End point type
    Primary
    End point timeframe
    3 months post-transplant
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: mcU/ml
        median (inter-quartile range (Q1-Q3))
    7.57 (4.56 to 8.70)
    9.22 (6.61 to 10.46)
    Statistical analysis title
    		 ISI - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.2
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 ISI - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.2
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: IGI- Insulinogenic Index

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    End point title
    		 IGI- Insulinogenic Index
    End point description
    3-month post-transplant Insulinogenic Index
    End point type
    Primary
    End point timeframe
    3-month post-transplant
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: mcU/ml
        median (inter-quartile range (Q1-Q3))
    46.65 (19.10 to 68.90)
    47.87 (24.46 to 172.78)
    Statistical analysis title
    		 IGI - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.96
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 IGI - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.96
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Fasting Glucose Levels (FGL)

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    End point title
    		 Fasting Glucose Levels (FGL)
    End point description
    End point type
    Primary
    End point timeframe
    Fasting Glucose Levels at: 1 week 1 month 2 months 3 months
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: mg/dl
    median (inter-quartile range (Q1-Q3))
        1 week
    106.50 (96.75 to 116)
    100 (94.25 to 121.75)
        1 month
    90 (84.50 to 98.25)
    89.50 (86 to 99.75)
        2 months
    100 (88.25 to 112.50)
    89 (85.25 to 105)
        3 months
    95.50 (87.75 to 104.25)
    88 (78.50 to 96.25)
    Statistical analysis title
    		 FGL - 1 week - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.88
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 FGL - 1 week - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.88
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 FGL - 1 month - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.69
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 FGL - 1 month - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.69
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 FGL - 2 months - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.68
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 FGL - 2 months - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.68
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 FGL - 3 months - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.24
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 FGL - 3 months - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.24
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Delayed Graft Function

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    End point title
    		 Delayed Graft Function
    End point description
    Delayed Graft Function is defined as needed for haemodialysis in the first-week post-transplantation
    End point type
    Secondary
    End point timeframe
    Delayed Graft Function in the first-week post-transplantation
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: subjects
    10
    2
    Statistical analysis title
    		 Delayed Graft Function - R-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.02
    Method
    		 Chi-squared
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.21
         upper limit
    		 0.56
    Statistical analysis title
    		 Delayed Graft Function - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.02
    Method
    		 Chi-squared
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 0.24

    Secondary: Plasma Creatinine Levels

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    End point title
    		 Plasma Creatinine Levels
    End point description
    End point type
    Secondary
    End point timeframe
    Creatinine post-transplant levels at the following times: 1 month 2 months 3 months
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: mg/dl
    median (inter-quartile range (Q1-Q3))
        1 month
    1.89 (1.66 to 2.64)
    1.60 (1.24 to 1.77)
        2 months
    1.85 (1.61 to 1.97)
    1.41 (1.20 to 1.87)
        3 months
    1.62 (1.42 to 1.93)
    1.48 (1.14 to 1.79)
    Statistical analysis title
    		 Plasma Creatinine Levels-1 month-IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.07
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Plasma Creatinine Levels-1 month-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.07
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Plasma Creatinine Levels-2 months-IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.14
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Plasma Creatinine Levels-2 months-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.14
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Plasma Creatinine Levels-3 months-IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.36
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Plasma Creatinine Levels-3 months-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.36
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Glomerular Filtration Rate (MDRD)

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    End point title
    		 Glomerular Filtration Rate (MDRD)
    End point description
    End point type
    Secondary
    End point timeframe
    Estimated glomerular filtration rate post-transplant at the following times: 1 month 2 months 3 months
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: ml/min/1,73m2
    arithmetic mean (standard deviation)
        1 month
    39.23 ( 16.57 )
    49.16 ( 15.74 )
        2 months
    41.16 ( 14.36 )
    48.92 ( 13.95 )
        3 months
    44.68 ( 13.99 )
    51.28 ( 15.48 )
    Statistical analysis title
    		 GFR 1 month - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.03
    Method
    		 t-student
    Confidence interval
    Variability estimate
    Standard deviation
    Dispersion value
    16.57
    Statistical analysis title
    		 GFR 1 month - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.03
    Method
    		 t-student
    Confidence interval
    Variability estimate
    Standard deviation
    Dispersion value
    15.74
    Statistical analysis title
    		 GFR 2 months - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.05
    Method
    		 t-student
    Confidence interval
    Variability estimate
    Standard deviation
    Dispersion value
    14.36
    Statistical analysis title
    		 GFR 2 months - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.05
    Method
    		 t-student
    Confidence interval
    Variability estimate
    Standard deviation
    Dispersion value
    13.95
    Statistical analysis title
    		 GFR 3 months - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.11
    Method
    		 t-student
    Confidence interval
    Variability estimate
    Standard deviation
    Dispersion value
    13.99
    Statistical analysis title
    		 GFR 3 months - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.11
    Method
    		 t-student
    Confidence interval
    Variability estimate
    Standard deviation
    Dispersion value
    15.48

    Secondary: Proteinuria Levels

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    End point title
    		 Proteinuria Levels
    End point description
    End point type
    Secondary
    End point timeframe
    Proteinuria level at 3 months post-transplant.
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: mg/gr creatinine
        median (inter-quartile range (Q1-Q3))
    153.62 (140.73 to 224.78)
    146.73 (121.29 to 178.58)
    Statistical analysis title
    		 Proteinuria - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.9
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Proteinuria - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.9
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Tacrolimus Levels

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    End point title
    		 Tacrolimus Levels
    End point description
    End point type
    Secondary
    End point timeframe
    Tacrolimus levels at the following times post-transplant: 1 week 1 month 2 months 3 months
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: ng/ml
    median (inter-quartile range (Q1-Q3))
        1 week
    9.25 (6.65 to 12.75)
    10.20 (9.40 to 11.30)
        1 month
    9.40 (7.63 to 10.28)
    9.20 (7.48 to 11.48)
        2 months
    9.50 (6.80 to 11.25)
    10.35 (7.93 to 12.03)
        3 months
    7.70 (6.93 to 8.58)
    10.35 (7.60 to 11.95)
    Statistical analysis title
    		 1 week-Tacrolimus Level-IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.21
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 1 week-Tacrolimus Level-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.21
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 1 month-Tacrolimus Level-IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.99
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 1 month-Tacrolimus Level-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.99
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 2 months-Tacrolimus Level-IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.21
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 2 months-Tacrolimus Level-IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.21
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 3 months-Tacrolimus Level-IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 3 months-Tacrolimus Level-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Pharmacokinetic Study (Median of 9 days post-transplantation)

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    End point title
    		 Pharmacokinetic Study (Median of 9 days post-transplantation)
    End point description
    End point type
    Secondary
    End point timeframe
    Average Tacrolimus doses and levels (mg/day) for each tacrolimus formulation at the following times: C0-basal (ng/ml) C1-2h (ng/ml) C2-4h (ng/ml) C3-6h (ng/ml) C4-8h (ng/ml) C5 12h (ng/ml) C6 24h (ng/ml)
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: ng/ml
    arithmetic mean (standard deviation)
        C0-basal
    9.7250 ( 3.81615 )
    10.4167 ( 3.36887 )
        C1-2h
    16.0250 ( 6.02197 )
    14.5550 ( 7.25846 )
        C2-4h
    13.110 ( 4.56577 )
    20.2000 ( 9.40097 )
        C3-6h
    11.0900 ( 3.11176 )
    19.8917 ( 8.11686 )
        C4-8h
    10.0500 ( 2.99710 )
    20.1813 ( 7.43310 )
        C5 12h
    8.5263 ( 2.73878 )
    16.3083 ( 5.90887 )
        C6 24h
    8.0550 ( 2.43342 )
    10.7958 ( 4.10551 )
    No statistical analyses for this end point

    Secondary: Plasma Magnesium Levels

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    End point title
    		 Plasma Magnesium Levels
    End point description
    End point type
    Secondary
    End point timeframe
    Plasma Magnesium Levels at the following times post-transplant.
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: mg/dl
    median (inter-quartile range (Q1-Q3))
        Mg - 1weeK
    1.95 (1.70 to 2.18)
    1.70 (1.63 to 2.08)
        Mg - 1month
    1.50 (1.33 to 1.68)
    1.60 (1.35 to 1.60)
        Mg - 2months
    1.60 (1.50 to 1.70)
    1.60 (1.43 to 1.70)
    Statistical analysis title
    		 Mg - 1week-IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.42
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Mg - 1week-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.42
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Mg - 1 month-IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.91
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Mg - 1 month-Mg-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.91
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Mg - 2 month-IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.91
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Mg - 2 month-Mg-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.91
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Other pre-specified: Body Mass Index (BMI)

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    End point title
    		 Body Mass Index (BMI)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Body Mass Index (BMI) 3 months post-transplant.
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: Kg/m2
        arithmetic mean (standard deviation)
    28.34 ( 4.64 )
    26.02 ( 3.71 )
    Statistical analysis title
    		 BMI - 3months - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.06
    Method
    		 t-student
    Confidence interval
    Statistical analysis title
    		 BMI - 3months - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.06
    Method
    		 t-student
    Confidence interval

    Other pre-specified: Cholesterol Levels

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    End point title
    		 Cholesterol Levels
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Cholesterol Levels 3months post-transplant.
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    24
    23
    Units: mg/dl
        arithmetic mean (standard deviation)
    192.63 ( 38.52 )
    176.96 ( 40.17 )
    Statistical analysis title
    		 Cholesterol - 3months - IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.18
    Method
    		 t-student
    Confidence interval
    Statistical analysis title
    		 Cholesterol - 3months - LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.18
    Method
    		 t-student
    Confidence interval

    Other pre-specified: HDL- Cholesterol

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    End point title
    		 HDL- Cholesterol
    End point description
    End point type
    Other pre-specified
    End point timeframe
    High-density cholesterol 3 months post-transplant
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    23
    23
    Units: mg/dl
        arithmetic mean (standard deviation)
    52.04 ( 15.24 )
    53.87 ( 16.92 )
    Statistical analysis title
    		 HDL- 3 months post-transplant-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.7
    Method
    		 t-student
    Confidence interval
    Variability estimate
    Standard deviation
    Dispersion value
    15.24
    Statistical analysis title
    		 HDL- 3 months post-transplant-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.7
    Method
    		 t-student
    Confidence interval
    Dispersion value
    16.92

    Other pre-specified: LDL- Cholesterol

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    End point title
    		 LDL- Cholesterol
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Low-density cholesterol 3-months post-transplant
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    20
    22
    Units: mg/dl
        arithmetic mean (standard deviation)
    109.45 ( 32.16 )
    99.64 ( 33.63 )
    Statistical analysis title
    		 LDL - 3months-post-transplant-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.34
    Method
    		 t-student
    Confidence interval
    Variability estimate
    Standard deviation
    Dispersion value
    32.16
    Statistical analysis title
    		 LDL - 3months-post-transplant-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.34
    Method
    		 t-student
    Confidence interval
    Variability estimate
    Standard deviation
    Dispersion value
    33.63

    Other pre-specified: Triglycerides

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    End point title
    		 Triglycerides
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Triglycerides 3 months post-transplant
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: mg/dl
        median (inter-quartile range (Q1-Q3))
    132 (101 to 170)
    116 (100.50 to 143.50)
    Statistical analysis title
    		 Triglycerides - 3 months-post-transplant-IR-TAC
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.36
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Triglycerides - 3 months-post-transplant-LCTP
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.36
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Other pre-specified: Cumulative Steroid Dosage

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    End point title
    		 Cumulative Steroid Dosage
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Accumulated Steroid Dosage 3 months post-transplant
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: mg
        median (inter-quartile range (Q1-Q3))
    1321.25 (1189.38 to 1561.25)
    1195 (1173.75 to 1270)
    Statistical analysis title
    		 CSD - 3 months-post-transplant-IR-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 CSD - 3 months-post-transplant-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Other pre-specified: Acute Rejection

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    End point title
    		 Acute Rejection
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Acute Rejection 3 months post-transplant
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    27
    25
    Units: subjects
    3
    0
    Statistical analysis title
    		 Acute Rejection - 3 months post-transplant-TAC
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.2
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Acute Rejection - 3 months post-transplant-LCTP
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.2
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Other pre-specified: Ambulatory Blood Pressure Monitoring (ABPM)

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    End point title
    		 Ambulatory Blood Pressure Monitoring (ABPM)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    ABPM (Ambulatory Blood Pressure Monitoring) 3 months post-transplant
    End point values
    		 Final sample included in IR-TAC (PROGRAF) group Final sample included in LCTP (ENVARSUS) group
    Number of subjects analysed
    25
    25
    Units: mmHg
    arithmetic mean (standard deviation)
        ABPM systolic awake
    129.60 ( 12.55 )
    129.84 ( 12.78 )
        ABPM systolic asleep
    124.68 ( 13.19 )
    129.48 ( 16.92 )
        ABPM diastolic awake
    79.92 ( 8.11 )
    80.48 ( 8.61 )
        ABPM diastolic asleep
    75.32 ( 8.46 )
    77.80 ( 8.75 )
    Statistical analysis title
    		 ABPM-systolic awake-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.95
    Method
    		 t-student
    Confidence interval
    Statistical analysis title
    		 ABPM-systolic awake-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.95
    Method
    		 t-student
    Confidence interval
    Statistical analysis title
    		 ABPM-systolic asleep-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.27
    Method
    		 t-student
    Confidence interval
    Statistical analysis title
    		 ABPM-systolic asleep-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.27
    Method
    		 t-student
    Confidence interval
    Statistical analysis title
    		 ABPM-diastolic awake-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.81
    Method
    		 t-student
    Confidence interval
    Statistical analysis title
    		 ABPM-diastolic awake-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.81
    Method
    		 t-student
    Confidence interval
    Statistical analysis title
    		 ABPM-diastolic asleep-TAC (PROGRAF)
    Comparison groups
    Final sample included in IR-TAC (PROGRAF) group v Final sample included in LCTP (ENVARSUS) group
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.31
    Method
    		 t-student
    Confidence interval
    Statistical analysis title
    		 ABPM-diastolic asleep-LCTP (ENVARSUS)
    Comparison groups
    Final sample included in LCTP (ENVARSUS) group v Final sample included in IR-TAC (PROGRAF) group
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.31
    Method
    		 t-student
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events in the first three months post-transplantation
    Adverse event reporting additional description
    The study collects the Severe and Non-Severe Adverse Effects of patients eventually included in both arms of the study. An overall analysis is performed and stratified by sex.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    IR-TAC (PROGRAF)- Female Sex
    Reporting group description
    		 This group is composed of female sex patients included in the study who have been treated with IR-CT (PROGRAF) from randomization to three-month follow-up.

    Reporting group title
    LCTP (ENVARSUS)- Female Sex
    Reporting group description
    		 This group is composed of female sex patients included in the study who have been treated with LCTP (ENVARSUS) from randomization to three-month follow-up.

    Reporting group title
    IR-TAC (PROGRAF)- Male Sex
    Reporting group description
    		 This group is composed of male sex patients included in the study who have been treated with IR-CT (PROGRAF) from randomization to three-month follow-up.

    Reporting group title
    LCTP (ENVARSUS)- Male Sex
    Reporting group description
    		 This group is composed of randomized and transplanted male sex patients who have been treated with LCTP (ENVARSUS) from randomization to three-month follow-up.

    Serious adverse events
    		 IR-TAC (PROGRAF)- Female Sex LCTP (ENVARSUS)- Female Sex IR-TAC (PROGRAF)- Male Sex LCTP (ENVARSUS)- Male Sex
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 10 (70.00%)
    2 / 6 (33.33%)
    9 / 17 (52.94%)
    10 / 19 (52.63%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Surgical and medical procedures
    Surgical and medical procedures
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 6 (0.00%)
    6 / 17 (35.29%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    2 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    2 / 17 (11.76%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatobiliary disorders
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    4 / 10 (40.00%)
    2 / 6 (33.33%)
    3 / 17 (17.65%)
    4 / 19 (21.05%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 2
    1 / 3
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    5 / 10 (50.00%)
    0 / 6 (0.00%)
    4 / 17 (23.53%)
    4 / 19 (21.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    1 / 6
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Product Issues
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    3 / 19 (15.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 IR-TAC (PROGRAF)- Female Sex LCTP (ENVARSUS)- Female Sex IR-TAC (PROGRAF)- Male Sex LCTP (ENVARSUS)- Male Sex
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 10 (60.00%)
    3 / 6 (50.00%)
    7 / 17 (41.18%)
    5 / 19 (26.32%)
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    1 / 17 (5.88%)
    2 / 19 (10.53%)
         occurrences all number
    0
    1
    1
    2
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    6 / 10 (60.00%)
    2 / 6 (33.33%)
    6 / 17 (35.29%)
    4 / 19 (21.05%)
         occurrences all number
    6
    2
    6
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jun 2017
    Protocol Version 2, 12JAN2018 Changes in the protocol generated in the initial authorization process by the AEMPS (Spanish Agency of Medicines and Health Products).
    08 Jan 2018
    Protocol version 3, 08JAN2018. Relevant Amendment nº1 Changes to the protocol and changes to the Patient Information and Consent Form.
    19 Feb 2019
    Protocol version 4, 17OCT2018. Relevant amendment Nº2 - The administration of Envarsus® in the trial was modified. It was remained under the responsibility of the project during the patient's stay in Hospital, and once the patient had been discharged, it was dispensed via Social Security outpatient prescription. - Extension of a Centre (Complejo Hospitalario de La Coruña)
    17 Feb 2020
    Protocol version 5, 17FEB2020. No relevant Amendment - Change of project manager and monitor. - Change of recruitment time and end of study. - Elimination of blood glucose during the last three days of the visits. - Oral Glucose Overload and Iohexol were administered only under clinical stability.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    14 Mar 2020
    Transplant activity was reduced due to the COVID-19 pandemic.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    No firm conclusions can be drawn from this study due to its exploratory nature. Non-inclusion of a graft biopsy per protocol at the end of the study to provide a morphological substrate for the differences observed in the filtration between groups.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27340950
    http://www.ncbi.nlm.nih.gov/pubmed/32463180
    http://www.ncbi.nlm.nih.gov/pubmed/25278376
    http://www.ncbi.nlm.nih.gov/pubmed/29162334
    http://www.ncbi.nlm.nih.gov/pubmed/37116012
    http://www.ncbi.nlm.nih.gov/pubmed/30552587
    http://www.ncbi.nlm.nih.gov/pubmed/30450457
    http://www.ncbi.nlm.nih.gov/pubmed/36083994
    http://www.ncbi.nlm.nih.gov/pubmed/26538615
    http://www.ncbi.nlm.nih.gov/pubmed/31611066
    http://www.ncbi.nlm.nih.gov/pubmed/30622369
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