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    Summary
    EudraCT Number:2019-001587-30
    Sponsor's Protocol Code Number:012657
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-06-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2019-001587-30
    A.3Full title of the trial
    AZD1656 in Transplantation with Diabetes tO PromoTe Immune TOleraNce
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The ADOPTION Study: AZD1656 in Transplantation with Diabetes tO PromoTe Immune TOleraNce
    A.3.2Name or abbreviated title of the trial where available
    The ADOPTION Study
    A.4.1Sponsor's protocol code number012657
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorQueen Mary University London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDiabetic Kidney Disease Centre (Barts Health NHS Trust)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiabetic Kidney Disease Centre
    B.5.2Functional name of contact pointDr Kieran McCafferty
    B.5.3 Address:
    B.5.3.1Street AddressRoyal London Hospital, Whitechapel Road
    B.5.3.2Town/ cityWhitechapel, London
    B.5.3.3Post codeE1 1BB
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailkieran.mccafferty4@nhs.net
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAZD1656
    D.3.2Product code AZD1656
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    renal transplant AND type 2 diabetes
    E.1.1.1Medical condition in easily understood language
    kidney transplant
    diabetes
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023438
    E.1.2Term Kidney transplant
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term Diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Will treating post-transplant patients with glucokinase activator (AZD1656) compared to placebo for 3 months improve the function of their transplant kidney via a change in the levels of immune cells (regulatory T cells)? We will measure this by measuring the number of regulatory T cells in blood samples taken from the patients.
    E.2.2Secondary objectives of the trial
    We will also be assessing whether the regulatory T cells leave the circulation and migrate to the transplant kidney by looking for them with a histological stain in the two biopsies which are routinely taken as part of standard of care: at time of implantation and at 3 months.

    We will be assessing the transplant function by monitoring the incidence of delayed graft function (defined as the need for dialysis within the first week post-transplant) and by measuring eGFR (a measure of kidney function) at 3 months.

    As glucokinase activators have also been shown to have a (transient) effect on lowering blood sugars, we will be investigating the effect of AZD1656 on the glycaemic control of participants by assessing:
    a) HbA1c monitoring between baseline and 3 months
    b) the dose of any other anti-diabetic medication required between baseline and 3 months
    c) insulin resistance by performing a homeostatic measurement at 3 months
    d) the number of any hypoglycaemic episodes

    We will also monit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Females or males aged 18 years and above
    b) Having undergone renal transplantation at the Royal London Hospital within the previous 24 hours
    c) A pre-transplant diagnosis of Type 2 diabetes
    d) Provision of written, informed consent prior to any study specific procedures
    e) In women of childbearing potential* documentation of a negative pregnancy test during admission for renal transplant.
    *Women of childbearing potential are defined as women following menarche until becoming post-menopausal, unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A post-menopausal state is defined as the absence of menses for 12 months without an alternative medical cause.
    E.4Principal exclusion criteria
    a) Unable to consent
    b) Known allergy/intolerance to AZD1656
    c) Pregnant or breastfeeding women
    d) Planning on becoming pregnant/unwilling to use highly effective contraception* during the 3 month treatment period and for 2 weeks afterwards
    a. In the case of men with sexual partners who are women of childbearing potential: refusal to wear a condom and female partner planning on becoming pregnant/unwilling to use highly effective contraception* during the 3 month treatment period and for 2 weeks afterwards
    e) Clinically significant history of abnormal physical and/or mental health as judged by the investigator other than conditions related to chronic kidney disease
    f) Current or planned use of strong inhibitors of CYP2C8
    g) Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug

    *Highly effective contraception methods are defined as those that can achieve a failure rate of <1% per year when used correctly and consistently. These include:
    • Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation – either oral, transvaginal or transdermal
    • Progestogen-only hormonal contraception associated with inhibition of ovulation – either oral, injectable or implantable
    • Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
    • Bilateral tubal occlusion
    • Vasectomised partner – provided that the partner is the sole sexual partner of the participant and that the vasectomised partner has received medical assessment of surgical success
    • Sexual abstinence – refrain from heterosexual intercourse for the duration of period defined to be at risk
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is the change in mean peripheral Treg cell number between baseline and 3 months post-transplant as measured using flow cytometry analysis (FACS) between patients receiving AZD1656 and placebo.
    This will be analysed during the first data analysis (see below).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time point of primary end point is at 3 months post-transplant.
    E.5.2Secondary end point(s)
    1) Histological staining for T-reg cells in renal biopsy tissue between baseline and 3 month protocol biopsy
    2) Incidence of delayed graft function, defined as the need for dialysis within 1 week post-transplant
    3) Diabetic control between baseline and month 3 using change in HbA1c measurement
    4) Dose of other antidiabetic medication between baseline and month 3 (descriptive)
    5) Safety endpoints: i.e. number of hypoglycaemic episodes (descriptive)
    6) Insulin resistance: HOMA IR measurement at month 3
    7) Graft function: (eGFR) at month 3
    8) Episodes of acute rejection (defined as biopsy proven acute rejection)
    9) Episodes of opportunistic infections: bacterial and viral (descriptive)
    10) 12-month graft function (eGFR) and diabetic control (HbA1c) to assess legacy effect
    11) Differences in other peripheral T cell populations, measured by FACS analysis
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end-point assessment will take place during study visits at recruitment, and weeks 1, 2, 4, 8, 12 and 14 post-transplant. There will be a further assessment at 1 year post-transplant (9 months post-completion of study drug).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is the last follow-up point at 1 year post-transplant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    AZD1656 will not be available to any patient after the completion of the trial. If promising results are shown, it may be used in future research studies; it is not yet licensed for any other use.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-26
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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