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    Clinical Trial Results:
    A randomised controlled comparison of Campath−Tacrolimus vs IL2R MoAb −Tacrolimus / Mycophenolate as Induction−Maintenance immunosuppression in kidney transplantation.

    Summary
    EudraCT number
    		 2005-002856-17
    Trial protocol
    		 GB  
    Global end of trial date
    01 Jun 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Feb 2020
    First version publication date
    08 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SMHREN0501
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00246129
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College Healthcare NHS Trust
    Sponsor organisation address
    Pread Street, London, United Kingdom, W2 1NY
    Public contact
    Adam McLean, Imperial College Healthcare NHS Trust , adammclean@nhs.net
    Scientific contact
    Adam McLean, Imperial College Healthcare NHS Trust , adammclean@nhs.net
    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
    04 Jun 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine which of two well established anti−rejection drug combinations has the best outcome in kidney transplantation. The investigational regime (Regime 1: IL2RMoAb−Tacrolimus/Mycophenolate) uses a combination of a relatively mild intial treatment with more potent long−term therapy, the second (comparator) regime (Regime 2: Campath−Tacrolimus) uses potent inital treatment, with simpler, less potent long−term treatment; this is our current standard baseline immunotherapeutic regime.
    Protection of trial subjects
    None
    Background therapy
    		 All patients received 3 months of CMV prophylaxis with 450 mg once daily Valganciclovir initially, adjusted for estimated glomerular filtration rate, and 6 months Pneumocystis prophylaxis with Co-Trimoxazole 480 mg three times per week. Both groups received a rapid steroid withdrawal regimen (0.5 g IV methyl-prednisolone intra-operatively at the release of vascular clamps with oral prednisolone 1 mg/kg up to max 60 mg on postoperative days 1 to 3 then prednisolone 0.5 mg/kg up to max 30 mg on days 4 to 7 followed by steroid cessation, unless rejection had occurred during the week 1.)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Oct 2005
    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
    United Kingdom: 123
    Worldwide total number of subjects
    123
    EEA total number of subjects
    123
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    116
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited between 2005 and 2011.

    Pre-assignment
    Screening details
    		 The kidney transplant participants were recruiting at the West London Renal and Transplant Centre.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Campath-Tacrolimus
    Arm description
    		 Patients received alemtuzumab induction as a single IV infusion of 30 mg alemtuzumab (MabCampath) on return from theaters with tacrolimus (Prograf, Astellas) monotherapy long-term maintenance. Tacrolimus initially was 0.1 mg/kg in two equally divided doses, adjusted to achieve target 12 hr trough levels of 5 to 8 ng/mL by liquid chromatography/tandem mass spectrometry (equivalent to 6.5–10 ng/mL measured by immunoassay).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Campath
    Investigational medicinal product code
    Other name
    Alemtuzumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received alemtuzumab induction as a single IV infusion of 30 mg on return from theatre

    Investigational medicinal product name
    Tacrolimus
    Investigational medicinal product code
    Other name
    Prograf, Astellas
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received on return from theaters and long-term monotherapy. Initially, 0.1 mg/kg in two equally divided doses, adjusted to achieve target 12 hr trough levels of 5 to 8 ng/mL by liquid chromatography/tandem mass spectrometry (equivalent to 6.5–10 ng/mL measured by immunoassay).

    Arm title
    		 Daclizumab-Tacrolimus-Mycophenolate
    Arm description
    		 Patients received daclizumab (Zenapax) induction given as 2x2 mg/kg infusions on return from theaters and on day 14, with combined tacrolimus/mycophenolate mofetil (CellCept) long-term maintenance.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tacrolimus
    Investigational medicinal product code
    Other name
    Prograf, Astellas
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Initially, 0.15 mg/kg in two divided doses, adjusted to target trough levels of 8 to 12 ng/mL (equivalent to 10 –15 ng/mL).

    Investigational medicinal product name
    Mycophenolate mofetil
    Investigational medicinal product code
    Other name
    Cellcept
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Initially, 500 mg BD adjusted to achieve target 12 hr trough mycophenolic acid levels of 1.5 to 3.0 mg/L.

    Investigational medicinal product name
    Daclizumab
    Investigational medicinal product code
    Other name
    Zenapax
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction given as 2x2 mg/kg infusions on return from theaters and on day 14.

    Number of subjects in period 1
    		Campath-Tacrolimus Daclizumab-Tacrolimus-Mycophenolate
    Started
    82
    41
    Completed
    75
    39
    Not completed
    7
    2
         death
    2
    1
         suffered primary non-function
    1
    -
         Lost to follow-up
    1
    -
         graft failed
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Campath-Tacrolimus
    Reporting group description
    		 Patients received alemtuzumab induction as a single IV infusion of 30 mg alemtuzumab (MabCampath) on return from theaters with tacrolimus (Prograf, Astellas) monotherapy long-term maintenance. Tacrolimus initially was 0.1 mg/kg in two equally divided doses, adjusted to achieve target 12 hr trough levels of 5 to 8 ng/mL by liquid chromatography/tandem mass spectrometry (equivalent to 6.5–10 ng/mL measured by immunoassay).

    Reporting group title
    Daclizumab-Tacrolimus-Mycophenolate
    Reporting group description
    		 Patients received daclizumab (Zenapax) induction given as 2x2 mg/kg infusions on return from theaters and on day 14, with combined tacrolimus/mycophenolate mofetil (CellCept) long-term maintenance.

    Reporting group values
    		 Campath-Tacrolimus Daclizumab-Tacrolimus-Mycophenolate Total
    Number of subjects
    		 82 41 123
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 77 39 116
        From 65-84 years
    		 5 2 7
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.3 ± 13.4 47.0 ± 10.6 -
    Gender categorical
    Units: Subjects
        Female
    		 28 14 42
        Male
    		 54 27 81

    End points

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    End points reporting groups
    Reporting group title
    Campath-Tacrolimus
    Reporting group description
    		 Patients received alemtuzumab induction as a single IV infusion of 30 mg alemtuzumab (MabCampath) on return from theaters with tacrolimus (Prograf, Astellas) monotherapy long-term maintenance. Tacrolimus initially was 0.1 mg/kg in two equally divided doses, adjusted to achieve target 12 hr trough levels of 5 to 8 ng/mL by liquid chromatography/tandem mass spectrometry (equivalent to 6.5–10 ng/mL measured by immunoassay).

    Reporting group title
    Daclizumab-Tacrolimus-Mycophenolate
    Reporting group description
    		 Patients received daclizumab (Zenapax) induction given as 2x2 mg/kg infusions on return from theaters and on day 14, with combined tacrolimus/mycophenolate mofetil (CellCept) long-term maintenance.

    Primary: One Year Survival With a Functioning Graft

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    End point title
    		 One Year Survival With a Functioning Graft
    End point description
    End point type
    Primary
    End point timeframe
    1 year
    End point values
    		 Campath-Tacrolimus Daclizumab-Tacrolimus-Mycophenolate
    Number of subjects analysed
    82
    41
    Units: Percent of transplant recipients
        number (confidence interval 90%)
    97.6 (90.6 to 99.4)
    95.1 (81.9 to 98.8)
    Statistical analysis title
    		 Functioning graft
    Comparison groups
    Campath-Tacrolimus v Daclizumab-Tacrolimus-Mycophenolate
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.467
    Method
    		 Logrank
    Confidence interval

    Secondary: Occurrence, Severity, and Type of Rejection Episodes

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    End point title
    		 Occurrence, Severity, and Type of Rejection Episodes
    End point description
    End point type
    Secondary
    End point timeframe
    1 year
    End point values
    		 Campath-Tacrolimus Daclizumab-Tacrolimus-Mycophenolate
    Number of subjects analysed
    82
    41
    Units: Percentage of transplant recipients
        number (confidence interval 90%)
    91.2 (82.4 to 95.7)
    82.3 (66.4 to 91.1)
    Statistical analysis title
    		 Rejection free survival
    Comparison groups
    Campath-Tacrolimus v Daclizumab-Tacrolimus-Mycophenolate
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.138
    Method
    		 Logrank
    Confidence interval

    Secondary: Occurrence, Severity, and Type of Infection Episodes

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    End point title
    		 Occurrence, Severity, and Type of Infection Episodes
    End point description
    End point type
    Secondary
    End point timeframe
    1 year
    End point values
    		 Campath-Tacrolimus Daclizumab-Tacrolimus-Mycophenolate
    Number of subjects analysed
    82
    41
    Units: per 100 patient years
        number (not applicable)
    73
    76
    No statistical analyses for this end point

    Secondary: Initial Length of Stay in Hospital

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    End point title
    		 Initial Length of Stay in Hospital
    End point description
    End point type
    Secondary
    End point timeframe
    1 year
    End point values
    		 Campath-Tacrolimus Daclizumab-Tacrolimus-Mycophenolate
    Number of subjects analysed
    82
    41
    Units: day
        arithmetic mean (standard deviation)
    11.7 ± 6.4
    12.1 ± 7.6
    No statistical analyses for this end point

    Secondary: Early Development of Scarring in the Grafts

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    End point title
    		 Early Development of Scarring in the Grafts
    End point description
    End point type
    Secondary
    End point timeframe
    1 year
    End point values
    		 Campath-Tacrolimus Daclizumab-Tacrolimus-Mycophenolate
    Number of subjects analysed
    82
    41
    Units: Percentage of transplant recipients
        number (not applicable)
    96
    90
    No statistical analyses for this end point

    Secondary: Graft Function, Creatinin level

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    End point title
    		 Graft Function, Creatinin level
    End point description
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Campath-Tacrolimus Daclizumab-Tacrolimus-Mycophenolate
    Number of subjects analysed
    82
    41
    Units: mmol/L
        arithmetic mean (standard deviation)
    127.3 ± 36.2
    147.0 ± 69.1
    No statistical analyses for this end point

    Secondary: Patient Survival

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    End point title
    		 Patient Survival
    End point description
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Campath-Tacrolimus Daclizumab-Tacrolimus-Mycophenolate
    Number of subjects analysed
    82
    41
    Units: Percentage or transplant recipients
        number (not applicable)
    98
    98
    No statistical analyses for this end point

    Secondary: Graft Survival Censored for Death With Function

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    End point title
    		 Graft Survival Censored for Death With Function
    End point description
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Campath-Tacrolimus Daclizumab-Tacrolimus-Mycophenolate
    Number of subjects analysed
    82
    41
    Units: Percentage or transplant recipients
        number (not applicable)
    91
    95
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 years
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Campath-Tacrolimus
    Reporting group description
    		 Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy

    Reporting group title
    Daclizumab-Tacrolimus-Mycophenolate
    Reporting group description
    		 Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy

    Serious adverse events
    		 Campath-Tacrolimus Daclizumab-Tacrolimus-Mycophenolate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 82 (6.10%)
    5 / 41 (12.20%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Immune thrombocytopenic purpura
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    New-onset diabetes after transplantation
    Additional description: NODAT
         subjects affected / exposed
    4 / 82 (4.88%)
    5 / 41 (12.20%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Campath-Tacrolimus Daclizumab-Tacrolimus-Mycophenolate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    59 / 82 (71.95%)
    30 / 41 (73.17%)
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    31 / 82 (37.80%)
    9 / 41 (21.95%)
         occurrences all number
    31
    9
    Bacteraemia
         subjects affected / exposed
    15 / 82 (18.29%)
    9 / 41 (21.95%)
         occurrences all number
    15
    9
    Wound infection
         subjects affected / exposed
    6 / 82 (7.32%)
    6 / 41 (14.63%)
         occurrences all number
    6
    6
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 82 (1.22%)
    4 / 41 (9.76%)
         occurrences all number
    1
    4
    Other
         subjects affected / exposed
    6 / 82 (7.32%)
    2 / 41 (4.88%)
         occurrences all number
    6
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/21836540
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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