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    Clinical Trial Results:
    AN OPEN, RANDOMISED, MULTICENTRE CLINICAL STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF STEROID WITHDRAWAL WITH TACROLIMUS, MYCOPHENOLATE MOFETIL AND DACLIZUMAB AGAINST TACROLIMUS, MYCOPHENOLATE MOFETIL AND STEROIDS IN CHILDREN AFTER KIDNEY TRANSPLANTATION

    Summary
    EudraCT number
    2005-001348-22
    Trial protocol
    CZ   GB   SE   HU   BE   DE   IT  
    Global end of trial date
    25 Feb 2008

    Results information
    Results version number
    v2(current)
    This version publication date
    19 May 2016
    First version publication date
    20 Jun 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Non-system related, non-substantial update needed.

    Trial information

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    Trial identification
    Sponsor protocol code
    FG-506-02-43
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00296348
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    International Study Number: PRG-EC-0243, Acronym: TWIST
    Sponsors
    Sponsor organisation name
    Astellas Pharma Europe Ltd
    Sponsor organisation address
    Lovett House, Lovett Road, Staines, United Kingdom, TW18 3AZ
    Public contact
    Clinical Trial Disclosure, Astellas Pharma Europe Ltd, Astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Astellas Pharma Europe Ltd, 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Feb 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Feb 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Feb 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to investigate the impact of early corticosteroid withdrawal in paediatric renal transplant patients on growth expressed as change in height standard deviation score (SDS) from baseline to end of study (EOS).
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, ICH GCP Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Sep 2005
    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
    Sweden: 3
    Country: Number of subjects enrolled
    United Kingdom: 76
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Czech Republic: 8
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Hungary: 11
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Israel: 7
    Country: Number of subjects enrolled
    Poland: 23
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    South Africa: 4
    Country: Number of subjects enrolled
    Taiwan: 2
    Worldwide total number of subjects
    200
    EEA total number of subjects
    187
    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)
    92
    Adolescents (12-17 years)
    108
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was performed in 32 centers across 13 countries.

    Pre-assignment
    Screening details
    Screening took place at baseline visit day 0. Screening assessments included: patient data, pregnancy test, donor/organ data, surgical details, body, height, weight, vital signs, blood pressure, and routine laboratory evaluations.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    This was an open label study so there was no blinding necessary.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4)
    Arm description
    Arm 1 consisted of Tacrolimus, Mycophenolate mofetil (MMF), Daclizumab (MAB) and Corticosteriods as treatment for four days only.
    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
    Tacrolimus (both treatment arms): The initial daily dose was 0.3 mg/kg per os (oral) (p.o.) given in 2 doses (equals 0.15 mg/kg twice daily) post-operatively. The initial dose of 0.15 mg/kg of tacrolimus was to be administered within 12 hours after reperfusion. Recipients of a living donor organ could receive pre-dosing with tacrolimus according to the hospital’s routine practice. Subsequent oral tacrolimus doses would be adjusted based on clinical evidence of efficacy and occurrence of adverse events (AEs), and observing the following recommended tacrolimus whole blood trough level ranges: Day 0 -21: 10 - 20 ng/mL, Day 22 - 183: 5 - 15 ng/mL. Tacrolimus capsules were to be swallowed with fluid (preferably water, but not with grapefruit juice) at least 1 hour before meals or 2 hours after meals in the morning and in the evening. Administration of tacrolimus via nasogastric tube was allowed.

    Investigational medicinal product name
    Mycophenolate Mofetil
    Investigational medicinal product code
    Other name
    MMF
    Pharmaceutical forms
    Capsule, Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    MMF (both treatment arms): The initial dose of 600 mg/m^2 of MMF was to be given pre-operatively. The first postoperative dose of MMF was administered within 12 hours following reperfusion. The daily dose was 1200 mg/m^2 given in 2 doses (equals 600 mg/m^2 twice daily) for the first 2 weeks. Thereafter a daily dose was 600 mg/m^2 given in 2 doses (equals 300 mg/m^2 twice daily). The total daily dose could be adjusted if medically indicated.

    Investigational medicinal product name
    Daclizumab
    Investigational medicinal product code
    Other name
    MAB
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Daclizumab (used in treatment arm 1 only). The first dose of daclizumab of 1.0 mg/kg had to be administered intravenously within 24 hours before reperfusion. The second dose of daclizumab of 1.0 mg/kg had to be given intravenously on post-operative Day 14. Only 2 doses of daclizumab could be given. The calculated volume of daclizumab must be mixed with 50 mL of sterile 0.9% sodium chloride solution and administered via a central vein over a 15 minute period. When mixing the solution, it was not to be shaken, but gently inverted in order to avoid foaming. Care must be taken to assure sterility of the prepared solution because the drug product does not contain any antimicrobial preservatives or bacteriostatic agents.

    Investigational medicinal product name
    Corticosteroids
    Investigational medicinal product code
    Other name
    Methylprednisolone or equivalent
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous bolus use , Oral use
    Dosage and administration details
    Corticosteroids were not provided as study medication but were administered as additional immunosuppressive treatment. Corticosteroids – for treatment arm 1: Methylprednisolone or equivalent: Day 0*: 300-600 mg/m^2 i.v. bolus followed by oral (*= pre-, intra-, or post-operatively) Prednisone or equivalent: Day 1: 60 mg/m^2 p.o. Day 2: 40 mg/m^2 p.o. Day 3: 30 mg/m^2 p.o. Day 4: 20 mg/m^2 p.o. Day 5- 183: none

    Arm title
    Arm 2: Tacrolimus + MMF + Corticosteroids
    Arm description
    Arm 2 consisted of Tacrolimus, Mycophenolate mofetil (MMF) and Corticosteriods as treatment.
    Arm type
    Active comparator

    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
    Tacrolimus (both treatment arms): The initial daily dose was 0.3 mg/kg p.o. given in 2 doses (equals 0.15 mg/kg twice daily) post-operatively. The initial dose of 0.15 mg/kg of tacrolimus was to be administered within 12 hours after reperfusion. Recipients of a living donor organ could receive pre-dosing with tacrolimus according to the hospital’s routine practice. Subsequent oral tacrolimus doses would be adjusted based on clinical evidence of efficacy and occurrence of AEs, and observing the following recommended tacrolimus whole blood trough level ranges: Day 0 -21: 10 - 20 ng/mL, Day 22 - 183: 5 - 15 ng/mL. Tacrolimus capsules were to be swallowed with fluid (preferably water, but not with grapefruit juice) at least 1 hour before meals or 2 hours after meals in the morning and in the evening. Administration of tacrolimus via nasogastric tube was allowed.

    Investigational medicinal product name
    Mycophenolate Mofetil
    Investigational medicinal product code
    Other name
    MMF
    Pharmaceutical forms
    Capsule, Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    MMF (both treatment arms): The initial dose of 600 mg/m^2 of MMF was to be given pre-operatively. The first postoperative dose of MMF was administered within 12 hours following reperfusion. The daily dose was 1200 mg/m^2 given in 2 doses (equals 600 mg/m^2 twice daily) for the first 2 weeks. Thereafter a daily dose was 600 mg/m^2 given in 2 doses (equals 300 mg/m^2 twice daily). The total daily dose could be adjusted if medically indicated.

    Investigational medicinal product name
    Corticosteroids
    Investigational medicinal product code
    Other name
    Methylprednisolone or equivalent
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous bolus use , Oral use
    Dosage and administration details
    Corticosteroids were not provided as study medication but were administered as additional immunosuppressive treatment. Corticosteroids – for treatment arm 2: Methylprednisolone or equivalent: Day 0*: 300-600 mg/m^2 i.v. bolus followed by oral (*= pre, intra-, or post-op) Prednisone or equivalent: Day 1: 60 mg/m^2 p.o. Day 2-7: 40 mg/m^2 p.o. Day 8-14: 30 mg/m^2 p.o. Day 15-28: 20 mg/m^2 p.o. Day 29-42: 10 mg/m^2 p.o. Day 43-183: < 10 mg/m^2 p.o.

    Number of subjects in period 1
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Started
    100
    100
    Completed
    85
    84
    Not completed
    15
    16
         Investigator decision
    1
    -
         Protocol violation
    2
    -
         Not transplanted
    2
    2
         Adverse event
    8
    7
         Lack of efficacy
    2
    3
         Administrative
    -
    3
         Inadaptation of galenic form
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4)
    Reporting group description
    Arm 1 consisted of Tacrolimus, Mycophenolate mofetil (MMF), Daclizumab (MAB) and Corticosteriods as treatment for four days only.

    Reporting group title
    Arm 2: Tacrolimus + MMF + Corticosteroids
    Reporting group description
    Arm 2 consisted of Tacrolimus, Mycophenolate mofetil (MMF) and Corticosteriods as treatment.

    Reporting group values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids Total
    Number of subjects
    100 100 200
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Age values are based on the Full Analysis Set (FAS). The FAS contains all randomized and transplanted patients with results attributed to the treatment group that they were randomized to and who received at least one dose of study medication (tacrolimus, MMF, daclizumab or steroids).
    Units: years
        arithmetic mean (standard deviation)
    10.8 ± 4.2 11.3 ± 4.1 -
    Gender categorical
    Gender values are based on the FAS.
    Units: Subjects
        Female
    32 39 71
        Male
    66 59 125
        Subjects not included in FAS
    2 2 4
    Height
    Height values are based on the FAS.
    Units: cm
        arithmetic mean (standard deviation)
    134.4 ± 24.9 136.8 ± 23.9 -

    End points

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    End points reporting groups
    Reporting group title
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4)
    Reporting group description
    Arm 1 consisted of Tacrolimus, Mycophenolate mofetil (MMF), Daclizumab (MAB) and Corticosteriods as treatment for four days only.

    Reporting group title
    Arm 2: Tacrolimus + MMF + Corticosteroids
    Reporting group description
    Arm 2 consisted of Tacrolimus, Mycophenolate mofetil (MMF) and Corticosteriods as treatment.

    Primary: Growth, expressed as change in height Standard Deviation Score (SDS) from baseline to End of Study (EOS)

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    End point title
    Growth, expressed as change in height Standard Deviation Score (SDS) from baseline to End of Study (EOS)
    End point description
    The study analysis population for this endpoint consisted of the Primary Analysis Set (PAS). The PAS contains all randomized and transplanted patients who received at least one dose of study medication and who have valid measurements (i.e. excluding estimated values) of stature height at baseline and Month 6 (Visit 8 for completers, follow-up visit for withdrawn patients). Missing height at Visit 8 or at 6-month follow up (also for lost to follow-up patients) was estimated with the last available height (last observation carried forward (LOCF)). The change in height SDS from baseline will be calculated according to the formula: Δ SDS = SDSEOS - SDSbaseline, Where SDS = (heightmeasured - heightstandard population)/SDstandard population. The two treatment groups will be compared and tested for differences in mean change in height SDS from baseline.
    End point type
    Primary
    End point timeframe
    Baseline to End of Study (EOS), up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    93
    91
    Units: N/A (see SDS formula)
        arithmetic mean (standard deviation)
    0.17 ± 0.4
    0.04 ± 0.3
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    The two treatment groups will be compared and tested for differences in mean change in height SDS from baseline. The null and alternative hypotheses are: H0: μST = μSF versus Ha: μST ≠ μSF, where μST and μSF represent the mean change in height SDS from baseline to EOS in the steroid treated group (ST) and the steroid free group (SF) respectively.
    Comparison groups
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) v Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.005
    Method
    ANCOVA
    Parameter type
    Treatment group diff. in adj. mean ch.
    Point estimate
    0.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.04
         upper limit
    0.23
    Notes
    [1] - Parameter estimate: Treatment group difference in adjusted mean change. The primary endpoint was analyzed by ANCOVA with the factors treatment group, pubertal status and the covariate baseline height SDS on the primary analysis set.

    Secondary: Number of participants with acute rejections (AR)

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    End point title
    Number of participants with acute rejections (AR)
    End point description
    FAS population. SRAR: not treated with new/increasing corticosteroids, antibodies/other meds and resolved regardless of tacrolimus/MMF dose changes. CSAR: treated with new/increased corticosteroids only and resolved, regardless of tacrolimus/MMF dose changes. A corticosteroid resistant acute rejection (CRAR) was defined as a rejection episode which did not resolve following treatment with corticosteroids. Rejection episodes which were initially treated with antibodies only were also be included in this category. Other acute rejection: could not be classified into the above categories. Chronic rejections were identified from biopsy findings and AE reporting during medical review.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: Participants
        Acute rejections (AR)
    20
    16
        Spontaneously resolving acute rejections (SRAR)
    1
    0
        Corticosteroid sensitive acute rejections (CSAR)
    18
    14
        Corticosteroid resistant acute rejections (CRAR)
    2
    4
        Other rejections
    0
    0
        Chronic rejections
    0
    1
    No statistical analyses for this end point

    Secondary: Number of participants with corticosteroid-resistant acute rejections (CRAR)

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    End point title
    Number of participants with corticosteroid-resistant acute rejections (CRAR)
    End point description
    The study analysis population for this endpoint consisted of the FAS. A corticosteroid resistant acute rejection (CRAR) was defined as a rejection episode which did not resolve following treatment with corticosteroids. Rejection episodes which were initially treated with antibodies only were also be included in this category.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: Participants
        Corticosteroid resistant acute rejections (CRAR)
    2
    4
        Resolved with further treatment
    1
    3
        Unresolved with further treatment
    1
    0
        Unresolved without further treatment
    0
    1
    No statistical analyses for this end point

    Secondary: Overall AR episodes

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    End point title
    Overall AR episodes
    End point description
    The study analysis population for this endpoint consisted of the FAS.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: AR episodes
    24
    21
    No statistical analyses for this end point

    Secondary: Number of participants with biopsy-proven acute rejections (BPAR)

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    End point title
    Number of participants with biopsy-proven acute rejections (BPAR)
    End point description
    The study analysis population for this endpoint consisted of the FAS. An acute rejection episode was biopsy proven if one biopsy result between the start date and the stop date was classified as ‘mild acute rejection (Banff I)’, ‘moderate acute rejection (Banff II)’ or ‘severe acute rejection (Banff III)’.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: Participants
        Biopsy-proven acute rejections (BPAR)
    10
    7
        Biopsy-proven SRAR
    0
    0
        Biopsy-proven CSAR
    9
    5
        Biopsy-proven CRAR
    1
    3
        Other biopsy-proven rejections
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with biopsy-proven corticosteroid-resistant acute rejections (BCAR)

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    End point title
    Number of participants with biopsy-proven corticosteroid-resistant acute rejections (BCAR)
    End point description
    The study analysis population for this endpoint consisted of the FAS. An acute rejection episode was biopsy proven if one biopsy result between the start date and the stop date was classified as ‘mild acute rejection (Banff I)’, ‘moderate acute rejection (Banff II)’ or ‘severe acute rejection (Banff III)’.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: Participants
        Biopsy-proven corticosteroid-resistant AR (BCAR)
    1
    3
        Resolved with further treatment
    1
    3
        Unresolved with further treatment
    0
    0
        Unresolved without further treatment
    0
    0
    No statistical analyses for this end point

    Secondary: Overall BPAR episodes

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    End point title
    Overall BPAR episodes
    End point description
    The study analysis population for this endpoint consisted of the FAS.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: BPAR episodes
    13
    9
    No statistical analyses for this end point

    Secondary: Severity of BPARs

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    End point title
    Severity of BPARs
    End point description
    The study analysis population for this endpoint consisted of the FAS. The histological evaluation of biopsies for the grade of acute rejections were based on the Banff 97 working classification of renal allograft pathology.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: Biopsies
        No rejection
    43
    24
        Mild AR (Banff I)
    10
    6
        Moderate AR (Banff II)
    2
    3
        Severe AR (Banff III)
    1
    1
        Other
    28
    17
        Total
    84
    51
    No statistical analyses for this end point

    Secondary: Patient survival

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    End point title
    Patient survival
    End point description
    The study analysis population for this endpoint consisted of the FAS. Event and censor times for the Kaplan-Meier analyses of patient survival: day of death, day of last follow-up for withdrawn patients and day of last visit for completers and lost to follow-up.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: Percentage
        number (confidence interval 95%)
    99 (97 to 100)
    100 (100 to 100)
    No statistical analyses for this end point

    Secondary: Graft survival

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    End point title
    Graft survival
    End point description
    The study analysis population for this endpoint consisted of the FAS. Event and censor times for the Kaplan-Meier analyses of graft survival: day of graft loss, day of last follow-up for withdrawn patients and day of last visit for completers and lost to follow-up. Graft loss is defined as retransplantation, nephrectomy or death or as dialysis ongoing at study end or withdrawal of the patient from the study unless superseded by follow up information.
    End point type
    Secondary
    End point timeframe
    Up to 6 months
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: Percentage
        number (confidence interval 95%)
    96.9 (93.5 to 100)
    96.9 (93.5 to 100)
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events (AEs)

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    End point title
    Number of participants with adverse events (AEs)
    End point description
    The study analysis population for this endpoint consisted of the FAS. An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. The obligation to report AEs starts with the enrolment of a patient in the study.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: Participants
        Adverse Events
    95
    93
        Serious Adverse Events (SAEs)
    63
    60
        Causally-related adverse events
    76
    79
        Causally-related serious adverse events
    43
    37
    No statistical analyses for this end point

    Secondary: Absolute change in serum lipids

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    End point title
    Absolute change in serum lipids
    End point description
    The study analysis population for this endpoint consisted of the FAS.
    End point type
    Secondary
    End point timeframe
    Change from visit 1/baseline to visit 8/day 183 (up to 6 months).
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: mmol/L
    arithmetic mean (standard deviation)
        Total Cholesterol [N= 72, 74]
    -0.94 ± 1.666
    -0.42 ± 1.213
        LDL [N= 49, 56]
    -0.21 ± 0.863
    -0.3 ± 0.998
        HDL [N= 56, 62]
    0.04 ± 0.31
    0.05 ± 0.357
        Triglycerides [N= 68, 72]
    -1.14 ± 1.803
    -0.42 ± 1.174
    No statistical analyses for this end point

    Secondary: Number of participants with delayed graft function (DGF)

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    End point title
    Number of participants with delayed graft function (DGF)
    End point description
    Delayed graft function is defined as post-operative dialysis for more than one day during the time period from Day 0 to Day 7. Never functioning graft is defined as dialysis from the first week on until study end or withdrawal, unless a functioning graft was reported at follow-up.
    End point type
    Secondary
    End point timeframe
    Up to day 7 (week 1), DGF must be within 7 days of transplant .
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: Participants
    9
    11
    No statistical analyses for this end point

    Secondary: Duration of DGF

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    End point title
    Duration of DGF
    End point description
    The study analysis population for this endpoint consisted of the FAS.
    End point type
    Secondary
    End point timeframe
    Up to day 7 (week 1), DGF must be within 7 days of transplant .
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: Dialysis days
        median (full range (min-max))
    8 (3 to 18)
    4 (1 to 23)
    No statistical analyses for this end point

    Secondary: Number of participants with renal dysfunction

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    End point title
    Number of participants with renal dysfunction
    End point description
    The study analysis population for this endpoint consisted of the FAS. Renal dysfunction is defined as GFR < 40 mL/min/1.73m^2 (Schwartz formula) at Visit 8 (Month 6).
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: Participants
    7
    9
    No statistical analyses for this end point

    Secondary: Number of participants with post transplantation diabetes mellitus (PTDM)

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    End point title
    Number of participants with post transplantation diabetes mellitus (PTDM)
    End point description
    The study analysis population for this endpoint consisted of the FAS.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: Participants
    0
    7
    No statistical analyses for this end point

    Secondary: Number of participants with hypertension

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    End point title
    Number of participants with hypertension
    End point description
    The study analysis population for this endpoint consisted of the FAS.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    98
    98
    Units: Participants
    21
    25
    No statistical analyses for this end point

    Secondary: Time to first AR

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    End point title
    Time to first AR
    End point description
    The study analysis population for this endpoint consisted of subjects with AR. Time to first acute rejection episode was defined as the number of days from reperfusion to the first clinical, laboratory or histological signs that were considered to be related to the first acute rejection episode.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    20
    16
    Units: Days
        median (full range (min-max))
    35 (3 to 147)
    24 (2 to 116)
    No statistical analyses for this end point

    Secondary: Time to first CRAR

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    End point title
    Time to first CRAR
    End point description
    The study analysis population for this endpoint consisted of subjects with CRAR. Time to first corticosteroid resistant acute rejection episode was defined as the number of days from reperfusion to the first clinical, laboratory or histological signs that were considered to be related to the first CRAR episode.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    2
    4
    Units: Days
        median (full range (min-max))
    52.5 (9 to 96)
    43.5 (2 to 109)
    No statistical analyses for this end point

    Secondary: Time to first BPAR

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    End point title
    Time to first BPAR
    End point description
    The study analysis population for this endpoint consisted of subjects with BPAR. Time to first biopsy-proven acute rejection episode was defined as the number of days from reperfusion to the first clinical, laboratory or histological signs that were considered to be related to the first BPAR episode.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    10
    7
    Units: Days
        median (full range (min-max))
    26.5 (3 to 147)
    34 (2 to 116)
    No statistical analyses for this end point

    Secondary: Time to first BCAR

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    End point title
    Time to first BCAR
    End point description
    The study analysis population for this endpoint consisted of subjects with BCAR. Time to first biopsy-proven corticosteroid-resistant acute rejection episode was defined as the number of days from reperfusion to the first clinical, laboratory or histological signs that were considered to be related to the first BCAR episode.
    End point type
    Secondary
    End point timeframe
    Up to 6 months.
    End point values
    Arm 1: Tacrolimus+MMF+MAB(Daclizumab)+Corticosteroids(Day 0-4) Arm 2: Tacrolimus + MMF + Corticosteroids
    Number of subjects analysed
    1
    3
    Units: Days
        median (full range (min-max))
    9 (9 to 9)
    10 (2 to 77)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    An adverse event was considered treatment-emergent if it started on or after the day of first study medication intake(tacrolimus, MMF, MAB or steroids).
    Adverse event reporting additional description
    FAS population.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    8.0
    Reporting groups
    Reporting group title
    Tacrolimus + MMF + MAB (Daclizumab) + Corticosteroids
    Reporting group description
    This arm consisted of Tacrolimus, Mycophenolate mofetil (MMF), Daclizumab (MAB) and Corticosteriods as treatment.

    Reporting group title
    Tacrolimus + MMF + Corticosteroids
    Reporting group description
    This arm consisted of Tacrolimus, Mycophenolate mofetil (MMF) and Corticosteriods as treatment.

    Serious adverse events
    Tacrolimus + MMF + MAB (Daclizumab) + Corticosteroids Tacrolimus + MMF + Corticosteroids
    Total subjects affected by serious adverse events
         subjects affected / exposed
    63 / 98 (64.29%)
    60 / 98 (61.22%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    1 / 98 (1.02%)
    3 / 98 (3.06%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Medical device removal
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrostomy
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent placement
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lymphoproliferative disorder
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft loss
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site effusion
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complications of transplant surgery
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complications of transplanted kidney
         subjects affected / exposed
    2 / 98 (2.04%)
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft haemorrhage
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft thrombosis
         subjects affected / exposed
    1 / 98 (1.02%)
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Operative haemorrhage
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative respiratory distress
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent occlusion
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular procedure complication
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound complication
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    17 / 98 (17.35%)
    7 / 98 (7.14%)
         occurrences causally related to treatment / all
    11 / 20
    6 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glucose tolerance decreased
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immunosuppressant drug level decreased
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal stenosis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (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
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone marrow depression
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic uraemic syndrome
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 98 (1.02%)
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertonia
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder obstruction
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis proliferative
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    5 / 98 (5.10%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertonic bladder
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrocalcinosis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy toxic
         subjects affected / exposed
    8 / 98 (8.16%)
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    8 / 8
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery thrombosis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    4 / 98 (4.08%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal vein thrombosis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    1 / 98 (1.02%)
    3 / 98 (3.06%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    2 / 98 (2.04%)
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract disorder
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vesicoureteric reflux
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rhabdomyolysis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 98 (0.00%)
    4 / 98 (4.08%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus insulin-dependent
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid intake reduced
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (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
    Acute sinusitis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BK virus infection
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    2 / 98 (2.04%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter bacteraemia
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium colitis
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    5 / 98 (5.10%)
    10 / 98 (10.20%)
         occurrences causally related to treatment / all
    3 / 5
    8 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dental caries
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis infectious
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema infectiosum
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    2 / 98 (2.04%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    3 / 98 (3.06%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival infection
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis infectious mononucleosis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes simplex
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis bacterial
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection bacterial
         subjects affected / exposed
    3 / 98 (3.06%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    6 / 98 (6.12%)
    3 / 98 (3.06%)
         occurrences causally related to treatment / all
    4 / 7
    4 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection fungal
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral diarrhoea
         subjects affected / exposed
    2 / 98 (2.04%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    3 / 98 (3.06%)
    3 / 98 (3.06%)
         occurrences causally related to treatment / all
    1 / 3
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Tacrolimus + MMF + MAB (Daclizumab) + Corticosteroids Tacrolimus + MMF + Corticosteroids
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    79 / 98 (80.61%)
    82 / 98 (83.67%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    21 / 98 (21.43%)
    25 / 98 (25.51%)
         occurrences all number
    21
    25
    Injury, poisoning and procedural complications
    Complications of transplanted kidney
         subjects affected / exposed
    6 / 98 (6.12%)
    9 / 98 (9.18%)
         occurrences all number
    6
    9
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    17 / 98 (17.35%)
    12 / 98 (12.24%)
         occurrences all number
    24
    15
    Blood pressure increased
         subjects affected / exposed
    6 / 98 (6.12%)
    3 / 98 (3.06%)
         occurrences all number
    6
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    22 / 98 (22.45%)
    7 / 98 (7.14%)
         occurrences all number
    23
    7
    Leukopenia
         subjects affected / exposed
    5 / 98 (5.10%)
    1 / 98 (1.02%)
         occurrences all number
    5
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 98 (5.10%)
    5 / 98 (5.10%)
         occurrences all number
    7
    8
    Tremor
         subjects affected / exposed
    4 / 98 (4.08%)
    8 / 98 (8.16%)
         occurrences all number
    5
    10
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    8 / 98 (8.16%)
    6 / 98 (6.12%)
         occurrences all number
    12
    6
    Pyrexia
         subjects affected / exposed
    5 / 98 (5.10%)
    2 / 98 (2.04%)
         occurrences all number
    5
    2
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 98 (1.02%)
    6 / 98 (6.12%)
         occurrences all number
    1
    6
    Abdominal pain
         subjects affected / exposed
    7 / 98 (7.14%)
    5 / 98 (5.10%)
         occurrences all number
    7
    5
    Diarrhoea
         subjects affected / exposed
    22 / 98 (22.45%)
    20 / 98 (20.41%)
         occurrences all number
    27
    29
    Nausea
         subjects affected / exposed
    8 / 98 (8.16%)
    3 / 98 (3.06%)
         occurrences all number
    11
    3
    Vomiting
         subjects affected / exposed
    12 / 98 (12.24%)
    6 / 98 (6.12%)
         occurrences all number
    13
    7
    Renal and urinary disorders
    Nephropathy toxic
         subjects affected / exposed
    6 / 98 (6.12%)
    0 / 98 (0.00%)
         occurrences all number
    6
    0
    Renal tubular necrosis
         subjects affected / exposed
    5 / 98 (5.10%)
    3 / 98 (3.06%)
         occurrences all number
    5
    3
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    3 / 98 (3.06%)
    12 / 98 (12.24%)
         occurrences all number
    4
    14
    Hypokalaemia
         subjects affected / exposed
    2 / 98 (2.04%)
    6 / 98 (6.12%)
         occurrences all number
    2
    6
    Hypomagnesaemia
         subjects affected / exposed
    2 / 98 (2.04%)
    6 / 98 (6.12%)
         occurrences all number
    2
    6
    Hypophosphataemia
         subjects affected / exposed
    2 / 98 (2.04%)
    8 / 98 (8.16%)
         occurrences all number
    2
    8
    Infections and infestations
    Cytomegalovirus infection
         subjects affected / exposed
    7 / 98 (7.14%)
    5 / 98 (5.10%)
         occurrences all number
    8
    5
    Epstein-Barr virus infection
         subjects affected / exposed
    5 / 98 (5.10%)
    3 / 98 (3.06%)
         occurrences all number
    7
    3
    Febrile infection
         subjects affected / exposed
    7 / 98 (7.14%)
    0 / 98 (0.00%)
         occurrences all number
    9
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 98 (1.02%)
    5 / 98 (5.10%)
         occurrences all number
    1
    5
    Respiratory tract infection viral
         subjects affected / exposed
    6 / 98 (6.12%)
    2 / 98 (2.04%)
         occurrences all number
    9
    2
    Rhinitis
         subjects affected / exposed
    5 / 98 (5.10%)
    1 / 98 (1.02%)
         occurrences all number
    8
    1
    Urinary tract infection bacterial
         subjects affected / exposed
    13 / 98 (13.27%)
    12 / 98 (12.24%)
         occurrences all number
    18
    23
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 98 (3.06%)
    7 / 98 (7.14%)
         occurrences all number
    3
    10

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Feb 2006
    Amendment 2, a substantial amendment, (dated 20 February, 2006) allowed for the introduction of 2 sub-studies within this study; one for the study “Estimation of Rejection Risk in Kidney Recipients by Novel Immunological Markers” and one for study “Pharmacokinetics and Pharmacogenetics of tacrolimus and MMF”. These 2 sub-studies were performed only at trial sites which agreed to participate in the additional tests and obtained an approval by the responsible Ethics Committee and Competent Authority where applicable. These sub-studies and the obtained data do not form a part of the clinical report for study FG-506-02-43.
    17 Jul 2006
    Amendment 3, a substantial amendment, (dated 17 July, 2006) made the change that body height and weight were not to be measured at Visit 2 (Day 1 after operation), since children, unlike adults, are usually not mobilized on the day of surgery. This change did not jeopardize evaluation of study results since the main endpoint of the study compared patient height at baseline (before surgery) to that at the end of study (at 6 months after surgery).

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/25539467
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