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    Clinical Trial Results:
    A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus)/MMF, and Extended Release (XL) Tacrolimus /MMF in de novo Kidney Transplant Recipients

    Summary
    EudraCT number
    		 2015-002886-53
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Apr 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    27 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PRGXLKTx-0701-TW
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00717678
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Astellas Pharma Taiwan, Inc
    Sponsor organisation address
    5 F., No. 10, Sec. 3, Min-Sheng E. Rd., Taipei, Taiwan,
    Public contact
    Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., Astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., Astellas.resultsdisclosure@astellas.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Apr 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Apr 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF) and extended release (XL) tacrolimus/MMF in de novo kidney transplant recipients.
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    		 All participants were administered: (1) Corticosteroids (initial dose of methylprednisolone 500-1000 mg [or equivalent dose], intravenous bolus, given at time of skin closure following the completion of transplant procedure [considered "Day 0"] and subsequent dosing of methylprednisolone 200 mg/day [or equivalent dose] on Day 1 post-transplant, followed by tapered oral prednisone use from 30 mg to 5 mg by 12 months post-transplant); (2) Antibody induction therapy (depending on patient’s condition) consisting of interleukin-2 receptor antagonist monoclonal antibody, either daclizumab (Zenapax) or basilixmab (Simulect) per institutional protocol; and (3) Prophylaxis regimens for cytomegalovirus (CMV) and pneumocystis carinii pneumonia (PCP), standard antifungal prophylactic regimen and post-operative bacterial prophylactic regimen (per institutional protocol was given uniformly to all treatment groups).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Dec 2007
    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
    Taiwan: 73
    Worldwide total number of subjects
    73
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    3
    Adults (18-64 years)
    68
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at 5 sites in Taiwan.

    Pre-assignment
    Screening details
    		 Participants who were de novo kidney transplant recipients, consented to enter this study and fulfilled all the eligibility criteria were enrolled into the study. Screening assessments include recipient/donor serological status for cytomegalovirus (CMV), Epstein-Barr virus (EBV), hepatitis B and C viruses, and human immunodeficiency virus (HIV).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tacrolimus XL/MMF
    Arm description
    		 Participants who received tacrolimus extended release (XL) with mycophenolate mofetil (MMF) within 48 hours after the completion of a kidney transplant procedure.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tacrolimus XL
    Investigational medicinal product code
    FK506E
    Other name
    Extended release tacrolimus, Advagraf
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received an initial dose of 0.15-0.20 mg/kg of tacrolimus XL orally within 48 hours of the completion of a kidney transplant procedure. Subsequent/maintenance doses were adjusted on the basis of clinical evidence of efficacy and occurrence of adverse events, and targeted whole blood trough level ranges (Days 0-90: 7-16 ng/mL; Days 90+: 5-15 ng/mL).

    Investigational medicinal product name
    MMF
    Investigational medicinal product code
    Other name
    CellCept
    Pharmaceutical forms
    Tablet, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received an initial dose of 0.5-1.0 g of MMF orally twice daily within 48 hours of the completion of a kidney transplant procedure. Subsequent doses can be changed (once daily, three times daily or total daily dose change) at the Investigator’s discretion, if clinically indicated (i.e., if tolerability was a concern).

    Arm title
    		 Tacrolimus/MMF
    Arm description
    		 Participants who received tacrolimus with mycophenolate mofetil (MMF) within 48 hours after the completion of a kidney transplant procedure.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tacrolimus
    Investigational medicinal product code
    FK506
    Other name
    Prograf
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received an initial dose of 0.075-0.10 mg/kg of tacrolimus orally twice daily within 48 hours of the completion of a kidney transplant procedure. Subsequent/maintenance doses were adjusted on the basis of clinical evidence of efficacy and occurrence of adverse events, and targeted whole blood trough level ranges (Days 0-90: 7-16 ng/mL; Days 90+: 5-15 ng/mL).

    Investigational medicinal product name
    MMF
    Investigational medicinal product code
    Other name
    CellCept
    Pharmaceutical forms
    Tablet, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received an initial dose of 0.5-1.0 g of MMF orally twice daily within 48 hours of the completion of a kidney transplant procedure. Subsequent doses can be changed (once daily, three times daily or total daily dose change) at the Investigator’s discretion, if clinically indicated (i.e., if tolerability was a concern).

    Number of subjects in period 1
    		Tacrolimus XL/MMF Tacrolimus/MMF
    Started
    38
    35
    Safety population
    38
    31
    Intent-to-treat population
    38
    31
    Completed
    31
    25
    Not completed
    7
    10
         Discontinuation due to adverse events
    1
    3
         Graft loss
    3
    2
         Lost to follow-up
    -
    1
         Non-compliant with protocol
    -
    4
         Withdrew consent not related to AE
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tacrolimus XL/MMF
    Reporting group description
    		 Participants who received tacrolimus extended release (XL) with mycophenolate mofetil (MMF) within 48 hours after the completion of a kidney transplant procedure.

    Reporting group title
    Tacrolimus/MMF
    Reporting group description
    		 Participants who received tacrolimus with mycophenolate mofetil (MMF) within 48 hours after the completion of a kidney transplant procedure.

    Reporting group values
    		 Tacrolimus XL/MMF Tacrolimus/MMF Total
    Number of subjects
    		 38 35 73
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 2 1 3
        Adults (18-64 years)
    		 34 34 68
        From 65-84 years
    		 2 0 2
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.9 ( 13.71 ) 43.9 ( 9.948 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 11 35
        Male
    		 14 20 34
        Not reported due to protocol violation
    		 0 4 4

    End points

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    End points reporting groups
    Reporting group title
    Tacrolimus XL/MMF
    Reporting group description
    		 Participants who received tacrolimus extended release (XL) with mycophenolate mofetil (MMF) within 48 hours after the completion of a kidney transplant procedure.

    Reporting group title
    Tacrolimus/MMF
    Reporting group description
    		 Participants who received tacrolimus with mycophenolate mofetil (MMF) within 48 hours after the completion of a kidney transplant procedure.

    Primary: Graft survival during the 6 months post-transplant

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    End point title
    		 Graft survival during the 6 months post-transplant
    End point description
    Graft survival was defined as any participant who did not meet the definition of graft loss, which was defined as the death of the participant, retransplant or the permanent return to dialysis (greater than 30 days), or the participant became lost to follow-up. The analysis population was the intent-to-treat (ITT) population defined as randomized, transplanted participants who received at least one dose of their assigned study drug (tacrolimus/ tacrolimus XL) and had performed any study evaluation.
    End point type
    Primary
    End point timeframe
    Day 0 up to 6 months post-transplant
    End point values
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Number of subjects analysed
    38
    31
    Units: participants
    35
    29
    Statistical analysis title
    		 Comparison of 6-month graft survival rates
    Comparison groups
    Tacrolimus XL/MMF v Tacrolimus/MMF
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.993 [1]
    Method
    		 Logrank
    Confidence interval
    Notes
    [1] - The p-value was calculated by log-rank test to compare the survival distributions between treatment groups.

    Primary: Patient survival during the 6 months post-transplant

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    End point title
    		 Patient survival during the 6 months post-transplant [2]
    End point description
    Patient survival was defined as any participant known to be alive at 6 months after transplant. The analysis population was the ITT population.
    End point type
    Primary
    End point timeframe
    Day 0 up to 6 months post-transplant
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was performed since there were no deaths during the 6 months post-transplant.
    End point values
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Number of subjects analysed
    38
    31
    Units: participants
    38
    31
    No statistical analyses for this end point

    Secondary: Number of participants with efficacy failure during 6 and 12 months post-transplant

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    End point title
    		 Number of participants with efficacy failure during 6 and 12 months post-transplant
    End point description
    Efficacy failure was defined as any participant who died, experienced a graft loss, had a biopsy proven acute rejection, or was lost to follow-up. The analysis population was the ITT population.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 6 and 12 months post-transplant
    End point values
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Number of subjects analysed
    38
    31
    Units: participants
        6 months post-transplant
    5
    5
        12 months post-transplant
    5
    5
    No statistical analyses for this end point

    Secondary: Number of participants with biopsy confirmed acute rejection (BCAR) (Banff grade ≥ I) during 6 and 12 months post-transplant

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    End point title
    		 Number of participants with biopsy confirmed acute rejection (BCAR) (Banff grade ≥ I) during 6 and 12 months post-transplant
    End point description
    Rejection episodes require biopsies for confirmation, and the pathologist at the site was responsible for grading all biopsies using the 1997 Banff criteria: Grade I/Mild-IA: Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells) and IB: Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of severe tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells); Grade II/ Moderate-IIA: Cases with mild to moderate intimal arteritis in at least one arterial cross section and IIB: Cases with severe intimal arteritis comprising >25% of the luminal area lost in at least one arterial cross section; Grade III/Severe-Cases with “transmural” arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel. Analysis population was the ITT.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 6 and 12 months post-transplant
    End point values
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Number of subjects analysed
    38
    31
    Units: participants
        6 months post-transplant
    1
    2
        12 months post-transplant
    1
    2
    No statistical analyses for this end point

    Secondary: Time to first acute rejection episode

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    End point title
    		 Time to first acute rejection episode
    End point description
    Acute rejection was defined as first biopsy confirmed acute rejection from study drug first dose date. The analysis population was the ITT population. Due to the low number of participants who experienced BCAR, the Kaplan-Meier median time to first acute rejection could not be calculated and is denoted as "99999."
    End point type
    Secondary
    End point timeframe
    Day 1 up to 12 months post-transplant
    End point values
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Number of subjects analysed
    38
    31
    Units: months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Number of participants requiring anti-lymphocyte antibody therapy for treatment of rejection

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    End point title
    		 Number of participants requiring anti-lymphocyte antibody therapy for treatment of rejection
    End point description
    If a participant had histologically proven Banff Grade II/Moderate (IIA: Cases with mild to moderate intimal arteritis in at least one arterial cross section and IIB: Cases with severe intimal arteritis comprising >25% of the luminal area lost in at least one arterial cross section) or III/Severe (Cases with “transmural” arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel rejection, then the patient could be initiated on antilymphocyte antibodies as per institutional protocol. The analysis population was the ITT population.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 6 and 12 months post-transplant
    End point values
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Number of subjects analysed
    38
    31
    Units: participants
        6 months post-transplant
    0
    0
        12 months post-transplant
    0
    0
    No statistical analyses for this end point

    Secondary: Severity of acute rejection

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    End point title
    		 Severity of acute rejection
    End point description
    The severity of acute rejections was assessed using the 1997 Banff criteria: Grade I/Mild-IA: Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells) and IB: Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of severe tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells); Grade II/Moderate-IIA: Cases with mild to moderate intimal arteritis in at least one arterial cross section and IIB: Cases with severe intimal arteritis comprising >25% of the luminal area lost in at least one arterial cross section; Grade III/Severe - Cases with “transmural” arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel. "Not applicable" means no grade was given. Analysis population was participants in ITT with acute rejections.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 12 months post-transplant
    End point values
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Number of subjects analysed
    1
    2 [3]
    Units: rejections
        Grade IA
    1
    0
        Not applicable
    0
    2
    Notes
    [3] - As the 2 acute rejections were on the borderline, they were graded as not applicable.
    No statistical analyses for this end point

    Secondary: Number of participants with multiple rejection episodes

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    End point title
    		 Number of participants with multiple rejection episodes
    End point description
    The analysis population was the ITT population.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 6 months and 12 months post-transplant
    End point values
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Number of subjects analysed
    38
    31
    Units: participants
        6 months post-transplant
    0
    0
        12 months post-transplant
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with clinically treated acute rejection episodes

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    End point title
    		 Number of participants with clinically treated acute rejection episodes
    End point description
    Acute rejection episodes were treated with oral or intravenous (IV) corticosteroids with the dose not to exceed 1 gram/day for a maximum of 3-5 days. Subsequently, corticosteroids were tapered according to institutional practice. The analysis population was the ITT population.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 6 months and 12 months post-transplant
    End point values
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Number of subjects analysed
    38
    31
    Units: participants
        6 months post-transplant
    1
    2
        12 months post-transplant
    1
    2
    No statistical analyses for this end point

    Secondary: Number of participants with treatment failure

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    End point title
    		 Number of participants with treatment failure
    End point description
    Treatment failure is defined as discontinuation of randomized study drug for any reason. Participants who met the treatment failure definition were followed throughout the 12-month study.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 12 months post-transplant
    End point values
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Number of subjects analysed
    38
    31
    Units: participants
        12 months post-transplant
    7
    6
    No statistical analyses for this end point

    Secondary: Percentage of participants with renal function disorder

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    End point title
    		 Percentage of participants with renal function disorder
    End point description
    To detect acute rejection as early as possible, renal function was measured at each visit. Renal function disorder was defined as increased serum creatinine (>15%) as compared with baseline (Day 4). The analysis population was the ITT population.
    End point type
    Secondary
    End point timeframe
    Day 10, 14, 21, 28, 56, 84, 168, 274, 365 post-transplant
    End point values
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Number of subjects analysed
    38 [4]
    31 [5]
    Units: percentage of participants
    number (not applicable)
        Day 10 [N=38,31]
    5.3
    3.2
        Day 14 [N=38,30]
    10.5
    13.3
        Day 21 [N=37,31]
    8.1
    3.2
        Day 28 [N=37,30]
    13.5
    6.7
        Day 56 [N=35,28]
    22.9
    10.7
        Day 84 [N=35,28]
    28.6
    10.7
        Day 168 [N=34,27]
    20.6
    3.7
        Day 274 [N=34,26]
    26.5
    11.5
        Day 365 [N=38,29]
    18.4
    17.2
    Notes
    [4] - See [N=X,Y]; N= number of participants for whom serum creatinine data was available.
    [5] - See [N=X,Y]; N= number of participants for whom serum creatinine data was available.
    No statistical analyses for this end point

    Secondary: Patient survival during the 12 months post-transplant

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    End point title
    		 Patient survival during the 12 months post-transplant
    End point description
    Patient survival was defined as any participant known to be alive at the end of the study. The analysis population was the ITT population.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 12 months post-transplant
    End point values
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Number of subjects analysed
    38
    31
    Units: participants
    37
    31
    Statistical analysis title
    		 Comparison of 12-month patient survival rates
    Comparison groups
    Tacrolimus XL/MMF v Tacrolimus/MMF
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.38 [6]
    Method
    		 Logrank
    Confidence interval
    Notes
    [6] - The p-value was calculated by log-rank test to compare the survival distributions between treatment groups.

    Secondary: Graft survival during the 12 months post-transplant

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    End point title
    		 Graft survival during the 12 months post-transplant
    End point description
    Graft survival is defined as any participant who did not meet the definition of graft loss, which was defined as the death of the participant, retransplant or the permanent return to dialysis (greater than 30 days), or the participant became lost to follow-up. The analysis population was the ITT population.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 12 months post-transplant
    End point values
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Number of subjects analysed
    38
    31
    Units: participants
    35
    29
    Statistical analysis title
    		 Comparison of 12-month graft survival rates
    Comparison groups
    Tacrolimus XL/MMF v Tacrolimus/MMF
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.993 [7]
    Method
    		 Logrank
    Confidence interval
    Notes
    [7] - The p-value was calculated by log-rank test to compare the survival distributions between treatment groups.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to 28 days after last dose of study drug (up to 13 months)
    Adverse event reporting additional description
    IIT/Safety population
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Tacrolimus XL/MMF
    Reporting group description
    		 Participants who received tacrolimus extended release (XL) with mycophenolate mofetil (MMF) within 48 hours after the completion of a kidney transplant procedure.

    Reporting group title
    Tacrolimus/MMF
    Reporting group description
    		 Participants who received tacrolimus with mycophenolate mofetil (MMF) within 48 hours after the completion of a kidney transplant procedure.

    Serious adverse events
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 38 (50.00%)
    15 / 31 (48.39%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Transplant rejection
         subjects affected / exposed
    0 / 38 (0.00%)
    3 / 31 (9.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft versus host disease
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Cardiac murmur
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urine analysis abnormal
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Albumin globulin ratio abnormal
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood urea increased
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    White blood cell disorder
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pigmentation disorder
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Albuminuria
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oliguria
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 38 (7.89%)
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 38 (7.89%)
    4 / 31 (12.90%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital candidiasis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 38 (2.63%)
    4 / 31 (12.90%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis viral
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperuricaemia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tacrolimus XL/MMF Tacrolimus/MMF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 38 (100.00%)
    30 / 31 (96.77%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 38 (13.16%)
    6 / 31 (19.35%)
         occurrences all number
    6
    8
    Hypotension
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Haemorrhage
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Face oedema
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Pyrexia
         subjects affected / exposed
    4 / 38 (10.53%)
    6 / 31 (19.35%)
         occurrences all number
    5
    9
    Influenza like illness
         subjects affected / exposed
    1 / 38 (2.63%)
    3 / 31 (9.68%)
         occurrences all number
    1
    3
    Oedema
         subjects affected / exposed
    1 / 38 (2.63%)
    3 / 31 (9.68%)
         occurrences all number
    2
    3
    oedema peripheral
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    3
    Pain
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Immune system disorders
    Graft versus host disease
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    12 / 38 (31.58%)
    12 / 31 (38.71%)
         occurrences all number
    15
    23
    Dyspnoea
         subjects affected / exposed
    3 / 38 (7.89%)
    2 / 31 (6.45%)
         occurrences all number
    3
    3
    Pleural effusion
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    4 / 38 (10.53%)
    3 / 31 (9.68%)
         occurrences all number
    4
    3
    Depression
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    Insomnia
         subjects affected / exposed
    8 / 38 (21.05%)
    11 / 31 (35.48%)
         occurrences all number
    8
    11
    Investigations
    Albumin globulin ratio abnormal
         subjects affected / exposed
    4 / 38 (10.53%)
    3 / 31 (9.68%)
         occurrences all number
    4
    4
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 38 (10.53%)
    4 / 31 (12.90%)
         occurrences all number
    5
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 38 (5.26%)
    3 / 31 (9.68%)
         occurrences all number
    3
    3
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    12 / 38 (31.58%)
    12 / 31 (38.71%)
         occurrences all number
    16
    16
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    3 / 38 (7.89%)
    2 / 31 (6.45%)
         occurrences all number
    3
    2
    Tachycardia
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 38 (15.79%)
    4 / 31 (12.90%)
         occurrences all number
    6
    4
    Headache
         subjects affected / exposed
    3 / 38 (7.89%)
    3 / 31 (9.68%)
         occurrences all number
    4
    5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 38 (18.42%)
    9 / 31 (29.03%)
         occurrences all number
    8
    10
    Leukocytosis
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    White blood cell disorder
         subjects affected / exposed
    6 / 38 (15.79%)
    1 / 31 (3.23%)
         occurrences all number
    6
    1
    Thrombocytopenia
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 38 (15.79%)
    10 / 31 (32.26%)
         occurrences all number
    6
    14
    Constipation
         subjects affected / exposed
    11 / 38 (28.95%)
    10 / 31 (32.26%)
         occurrences all number
    13
    12
    Diarrhoea
         subjects affected / exposed
    11 / 38 (28.95%)
    8 / 31 (25.81%)
         occurrences all number
    14
    14
    Dyspepsia
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Flatulence
         subjects affected / exposed
    3 / 38 (7.89%)
    2 / 31 (6.45%)
         occurrences all number
    3
    3
    Gastritis
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    Nausea
         subjects affected / exposed
    3 / 38 (7.89%)
    3 / 31 (9.68%)
         occurrences all number
    3
    3
    Mouth ulceration
         subjects affected / exposed
    4 / 38 (10.53%)
    2 / 31 (6.45%)
         occurrences all number
    5
    3
    Vomiting
         subjects affected / exposed
    4 / 38 (10.53%)
    4 / 31 (12.90%)
         occurrences all number
    4
    5
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    3 / 38 (7.89%)
    4 / 31 (12.90%)
         occurrences all number
    3
    4
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Pruritus
         subjects affected / exposed
    3 / 38 (7.89%)
    1 / 31 (3.23%)
         occurrences all number
    4
    1
    Rash
         subjects affected / exposed
    4 / 38 (10.53%)
    3 / 31 (9.68%)
         occurrences all number
    4
    5
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    4 / 38 (10.53%)
    4 / 31 (12.90%)
         occurrences all number
    4
    4
    Oliguria
         subjects affected / exposed
    4 / 38 (10.53%)
    2 / 31 (6.45%)
         occurrences all number
    5
    2
    Urinary incontinence
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Myalgia
         subjects affected / exposed
    3 / 38 (7.89%)
    2 / 31 (6.45%)
         occurrences all number
    3
    2
    Back pain
         subjects affected / exposed
    4 / 38 (10.53%)
    2 / 31 (6.45%)
         occurrences all number
    4
    2
    Infections and infestations
    Fungal skin infection
         subjects affected / exposed
    1 / 38 (2.63%)
    3 / 31 (9.68%)
         occurrences all number
    1
    3
    Pharyngitis
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    Pneumonia
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Rhinitis
         subjects affected / exposed
    6 / 38 (15.79%)
    5 / 31 (16.13%)
         occurrences all number
    6
    5
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 38 (13.16%)
    1 / 31 (3.23%)
         occurrences all number
    5
    1
    Urinary tract infection
         subjects affected / exposed
    9 / 38 (23.68%)
    10 / 31 (32.26%)
         occurrences all number
    9
    14
    Herpes simplex
         subjects affected / exposed
    1 / 38 (2.63%)
    3 / 31 (9.68%)
         occurrences all number
    1
    3
    Herpes zoster
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Sepsis
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Cytomegalovirus infection
         subjects affected / exposed
    4 / 38 (10.53%)
    6 / 31 (19.35%)
         occurrences all number
    4
    8
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    3 / 38 (7.89%)
    5 / 31 (16.13%)
         occurrences all number
    3
    5
    Diabetes mellitus
         subjects affected / exposed
    2 / 38 (5.26%)
    4 / 31 (12.90%)
         occurrences all number
    2
    4
    Gout
         subjects affected / exposed
    3 / 38 (7.89%)
    0 / 31 (0.00%)
         occurrences all number
    3
    0
    Hypercalcaemia
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Hypercholesterolaemia
         subjects affected / exposed
    3 / 38 (7.89%)
    3 / 31 (9.68%)
         occurrences all number
    3
    3
    Hyperglycaemia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    8 / 38 (21.05%)
    8 / 31 (25.81%)
         occurrences all number
    8
    9
    Hyperkalaemia
         subjects affected / exposed
    6 / 38 (15.79%)
    6 / 31 (19.35%)
         occurrences all number
    6
    6
    Hyperlipidaemia
         subjects affected / exposed
    9 / 38 (23.68%)
    7 / 31 (22.58%)
         occurrences all number
    9
    8
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 38 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    0
    3
    Hyperuricaemia
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Hypocalcaemia
         subjects affected / exposed
    11 / 38 (28.95%)
    10 / 31 (32.26%)
         occurrences all number
    12
    11
    Hypokalaemia
         subjects affected / exposed
    6 / 38 (15.79%)
    3 / 31 (9.68%)
         occurrences all number
    6
    3
    Hypomagnesaemia
         subjects affected / exposed
    3 / 38 (7.89%)
    0 / 31 (0.00%)
         occurrences all number
    3
    0

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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.
    At this time,the original analysis data sets have been destroyed by the outsourced group who conducted this study (per SOP) and only the raw data (not final) from the CRFs are available. Some data required for this disclosure were obtained from this.
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