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    Clinical Trial Results:
    Tacrolimus vs prednisolone for the treatment of nephrotic syndrome secondary to minimal change disease: A Randomised Control Trial

    Summary
    EudraCT number
    		 2009-014292-52
    Trial protocol
    		 GB  
    Global end of trial date
    11 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Dec 2020
    First version publication date
    17 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GRIM1002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00982072
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial COllege Healthcare NHS Trust
    Sponsor organisation address
    du cane rd London, london, United Kingdom, W12 0HS
    Public contact
    Prof Megan Griffith, Prof Megan Griffith, +44 2033835272, m.e.griffith@imperial.ac.uk
    Scientific contact
    Prof Megan Griffith, Prof Megan Griffith, +44 2033835272, m.e.griffith@imperial.ac.uk
    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
    01 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Oct 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effectiveness of tacrolimus versus prednisolone for the treatment of nephrotic syndrome ((hypoalbuminaemia and urine protein/creatinine ratio (PCR) > 100units)) secondary to minimal change disease. The effectiveness of each treatment will be compared by the initial response rate (the proportion of patients achieving complete remission from nephrotic syndrome).
    Protection of trial subjects
    na
    Background therapy
    		 nil
    Evidence for comparator
    		 nil
    Actual start date of recruitment
    01 Dec 2009
    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
    United Kingdom: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 52 patients

    Pre-assignment
    Screening details
    		 minimal change disease

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 prednisolone
    Arm description
    		 prednisolone
    Arm type
    		 Active comparator

    Investigational medicinal product name
    prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1mg/kg/day

    Arm title
    		 tacrolimus
    Arm description
    		 tacrolimus
    Arm type
    		 Experimental

    Investigational medicinal product name
    tacrolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.05mg/kg bd

    Number of subjects in period 1
    		prednisolone tacrolimus
    Started
    25
    25
    Completed
    25
    25

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall study
    Reporting group description
    		 -

    Reporting group values
    		 overall study Total
    Number of subjects
    		 50 50
    Age categorical
    age
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 50 50
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 23 23
        Male
    		 27 27

    End points

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    End points reporting groups
    Reporting group title
    prednisolone
    Reporting group description
    		 prednisolone

    Reporting group title
    tacrolimus
    Reporting group description
    		 tacrolimus

    Primary: number of patients achieving complete remission of nephrotic syndrome at 8 weeks

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    End point title
    		 number of patients achieving complete remission of nephrotic syndrome at 8 weeks [1]
    End point description
    number of patients achieving complete remission of nephrotic syndrome at 8 weeks
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: as in published paper
    End point values
    		 prednisolone tacrolimus
    Number of subjects analysed
    25
    25
    Units: patients
    21
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    throughout trial. 2009-2019
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    prednisolone
    Reporting group description
    		 prednisolone

    Reporting group title
    tacrolimus
    Reporting group description
    		 tacrolimus

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The number of non serious adverse events is reported in the paper.
    Serious adverse events
    		 prednisolone tacrolimus
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 25 (16.00%)
    3 / 25 (12.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    hypertension
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
    Additional description: Headache
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticular perforation
    Additional description: as above
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory tract infection
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fracture radius
    Additional description: Fracture radius
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (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: 0%
    Non-serious adverse events
    		 prednisolone tacrolimus
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)

    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.
    Age range was 18-74

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31953303
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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