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    Clinical Trial Results:
    To test in a prospective double blind placebo controlled crossover trial if 24 weeks of Ursodeoxycholic acid Treatment in combination with established standard treatment for diabetic nephropathy significantly reduces albuminuria as compared to placebo in patients with T1DM and residual macroalbuminuria despite optimal RAAS blockade

    Summary
    EudraCT number
    		 2015-003609-41
    Trial protocol
    		 GB  
    Global end of trial date
    06 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Aug 2025
    First version publication date
    07 Aug 2025
    Other versions
    Summary report(s)
    		 CSR

    Trial information

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    Trial identification
    Sponsor protocol code
    UREDIA (2015-003609-41)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Dr Janaka Karalliedde, King's College London, 44 02078484297, j.karalliedde@kcl.ac.uk
    Scientific contact
    Dr Janaka Karalliedde, King's College London, 44 02078484297, j.karalliedde@kcl.ac.uk
    Sponsor organisation name
    Guy's and St Thomas NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE1 9RT
    Public contact
    Dr Janaka Karalliedde, Guy's and St Thomas' NHS Foundation Trust, 44 02078484297, j.karalliedde@kcl.ac.uk
    Scientific contact
    Dr Janaka Karalliedde, Guy's and St Thomas' NHS Foundation Trust, 44 02078484297, j.karalliedde@kcl.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
    14 Nov 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate if Ursodeoxycholic acid reduces albuminuria in patients with type 1 diabetes mellitus (T1DM) with residual albuminuria despite established standard care.
    Protection of trial subjects
    If at any time the (pregnancy) test does not come back negative (that is, it demonstrates that patient is pregnant), the patient will be withdrawn from participation in the study. Patients are free to withdraw from study treatment or from study at any time for any reason. Information collected during the trial may still be used. If patients decide to withdraw at any time they will be asked for consent to use all of the data collected up to the time they decided to leave the study. We will also ask for patient consent to use all the frozen blood samples which had not been analysed until withdrawal from the trial
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Mar 2017
    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: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    25
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 45 [1]
    Number of subjects completed
    		 31

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Patient not eligible: 10
    Reason: Number of subjects
    		 Consent withdrawn by subject: 3
    Reason: Number of subjects
    		 Other: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: We do not count screened participants as enrolled.
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    PL1
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500mg oral x2

    Arm title
    		 Active
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ursofalk 500mg film-coated tablets
    Investigational medicinal product code
    A05AA02
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000mg milligram(s) Oral

    Number of subjects in period 1
    		Placebo Active
    Started
    15
    16
    Completed
    15
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Active
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Active Total
    Number of subjects
    		 15 16 31
    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
    Units: years
        arithmetic mean (standard deviation)
    		 53.4 ( 14.2 ) 54.8 ( 13.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5 10
        Male
    		 10 11 21

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Active
    Reporting group description
    		 -

    Primary: Change in albuminuria

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    End point title
    		 Change in albuminuria [1]
    End point description
    To evaluate if Ursodeoxycholic acid reduces albuminuria in patients with type 1 diabetes mellitus (T1DM) with residual albuminuria despite established standard care.
    End point type
    Primary
    End point timeframe
    Baseline - week 24
    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: Please see uploaded report
    End point values
    		 Placebo Active
    Number of subjects analysed
    11
    13
    Units: mcg/min
        log mean (standard deviation)
    4.73 ( 1.75 )
    3.71 ( 1.69 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline - 48 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Ursodeoxycholic Acid

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Bowel Resection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol Dependence Syndrome
    Additional description: Assigned from SAE to IME after initial report
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (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
    Lower Respiratory Tract Infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (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
    Diabetic Ketoacidosis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (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
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 16 (37.50%)
    10 / 15 (66.67%)
    Investigations
    Creatinine blood increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Bruised left knee after falling
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Big toe fracture
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Right arm fracture
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Right arm operation
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Flu-like cold symptoms
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Flu-like symptoms
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Lipohypertrohy at abdominal injection sites
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Leg Swelling
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Eye disorders
    Acute Anterior Uveitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Excessive flatulence
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Lower stomach discomfort
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Worsening skin rash
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Backache
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Back Pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Leg Cramps
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Lower back pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Infections and infestations
    Bladder Infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Cellulitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Covid Infection
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    UTI
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 May 2018
    UREDIA Protocol version 4.1

    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
    For support, Contact us.
    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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