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    Summary
    EudraCT Number:2012-000452-34
    Sponsor's Protocol Code Number:3004
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-18
    Trial results View 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 ConcernedCzechia - SUKL
    A.2EudraCT number2012-000452-34
    A.3Full title of the trial
    Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria
    Proteomická predikce a inhibice systému renin angiotensin aldosteron k
    prevenci časné diabetické nefropatie u pacientů s diabetem typu 2 a
    normoalbuminurií
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prediction and prevention of kidney disease in patients with diabetes
    A.3.2Name or abbreviated title of the trial where available
    PRIORITY
    A.4.1Sponsor's protocol code number3004
    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 SponsorSteno Diabetes Center
    B.1.3.4CountryDenmark
    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 supportFP7 Program
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSteno Diabetes Center
    B.5.2Functional name of contact pointProf. Peter Rossing MD. DMSc
    B.5.3 Address:
    B.5.3.1Street AddressNiels Steensens Vej 2
    B.5.3.2Town/ cityGentofte
    B.5.3.3Post codeDK-2820
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4544437310
    B.5.5Fax number+4544438160
    B.5.6E-mailpro@steno.dk
    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 nameSpironolactone
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSPIRONOLACTONE
    D.3.9.1CAS number 52-01-7
    D.3.9.3Other descriptive nameSPIRONOLACTONE
    D.3.9.4EV Substance CodeSUB10631MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboFilm-coated tablet
    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
    Patients with type 2 diabetes mellitus and normoalbuminuria
    E.1.1.1Medical condition in easily understood language
    Diabetic patients with normal concentration of albumin in urine
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 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
    To confirm that urinary proteomics can predict development of
    microalbuminuria (as a surrogate marker for the development of overt
    nephropathy) in a cohort of 2000 type 2 diabetic patients with normal
    urinary albumin excretion.
    E.2.2Secondary objectives of the trial

    -To investigate if early initiation of preventive therapy with
    spironolactone 25 mg once daily reduces risk of transition to
    microalbuminuria in those patients identified by urinary proteomics to be
    at high risk
    -Assessment of safety in the intervention group
    -To compare the rate of change in UAER in high- vs. low-risk patients
    (based on the proteomic test), and to compare the effect of
    spironolactone on rate of change in UACR in the intervention study.
    -In addition, the objective is to study the rate of change in eGFR in
    relation to urinary marker pattern (CKD 273) and the intervention with
    spironolactone.
    -To study the ability of urinary proteomic patterns to predict
    cardiovascular or renal events during the study, as well as response to
    intervention in relation to study endpoints
    -To establish a biobank that will allow testing of additional putative
    markers for progression of diabetic nephropathy, development of
    cardiovascular events and death
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent must be provided before participation.
    Patient information and consent form must be approved by relevant
    independent EC. Specifically, all participating patients will be asked to
    give informed consent for long-term follow-up and collection of followup
    data
    XML File Identifier: LgutIXPCxi8i48QEjl8hMnUOCpU=
    Page 10/22
    • Male or female patients ≥ 18 years and < 75 years of age at Screening
    visit
    • Type 2 DM (WHO criteria)
    • Persistent normoalbuminuria (at least 2 of 3 UACR < 30 mg/g samples
    from "run in" period)
    • eGFR > 45 ml/min/1.73m2 at Screening visit
    • The patient must be willing and able to comply with the protocol for
    the duration of the study
    • Female without child-bearing potential at the screening visit. Defined
    as one or more of following:
    - Female patients ≥ 50 years of age at the day of inclusion, who have
    been postmenopausal for at least 1 year
    - Female patients < 50 years of age at the day of inclusion, who have
    been postmenopausal for at least 1 year and serum FSH levels > 40
    mIU/mL as well as serum estrogen levels < 30 pg/ml or a negative
    estrogen test
    - 6 weeks after surgical sterilization by bilateral tubal ligation or
    bilateral ovariectomy with or without hysterectomy
    OR a negative urine pregnancy test at the Screening visit AND one or
    more of the following:
    - Correct use of reliable contraception methods. This includes one or
    more ofthe following: hormonal contraceptive (such as injection,
    transdermal patch, implant, cervical ring or oral) or an intrauterine
    device (IUD) OR correct use of double barrier with one of the following:
    barrier methods (diaphragm, cervical cap, Lea contraceptive, femidom or
    condom) AND in combination with a spermicide
    - General sexual abstinence from the time of screening, during the study
    until a minimum of 30 days after the last administration of study
    medication if this is already established as the patient's preferred and
    usual lifestyle.
    - Having only female sexual partners
    - Sexual relationship with sterile male partners only
    E.4Principal exclusion criteria
    • Average of systolic BP < 110 or > 160 mm Hg at baseline
    • Average of diastolic BP > 100 mm Hg at baseline
    • Type 1 DM (WHO criteria)
    • HbA1c <6.5% (48 mmo l/ mol) AND > 5 years of known duration of
    diabetes type 2 AND never treated with a antidiabetic drug of any kind.
    • Current in treatment with more than one RAAS blocking agent
    (Angiotensin Converting Enzyme inhibitor, Angiotensin Receptor Blocker
    or Direct Renin Inhibitor)
    • Current lithium treatment (ATC: N05AN)
    • Known or suspected hypersensitivity to Spironolactone or to any of its
    excipients
    • Current use of potassium sparing diuretics (ATC: C03D, C03E), such as:
    Spironolactone, Eplerenone or amiloride etc
    • Hyperkalemia at Screening: plasma potassium level >5.0 mmol/L or
    serum potassium level >5.4 mmol/L.
    • Hyponatriemia determine by the investigator
    • Current cancer treatment or within five years from baseline (except
    basal cell skin cancer or squamous cell skin cancer)
    • Any clinically significant disorder, except for conditions as-sociated
    with type 2 DM history, which in the Investigators opinion could
    interfere with the results of the trial
    • Cardiac disease defined as: Heart failure (NYHA class III-IV) and/or
    diagnosis of unstable angina pectoris and/or MI, stroke, PTCA or CABG
    XML File Identifier: LgutIXPCxi8i48QEjl8hMnUOCpU=
    Page 11/22
    within the last 3 months
    • Diagnosis of non-Diabetic CKD current or in the past
    • Diagnosis of liver cirrhosis with current impaired liver function within
    the last 3 years.
    • Diagnosis of Addison's disease
    • Being lactating
    • Intend to become pregnant within the duration of the study or not use
    adequate birth control.
    • Known or suspected abuse of alcohol or narcotics
    • Not able to understand informed consent form
    • Participation in any other intervention trial than PRIORITY or a related
    sub-study is not allowed within 30 days before inclusion or concurrent to
    this study
    E.5 End points
    E.5.1Primary end point(s)
    Development of confirmed microalbuminuria (UACR>30 mg/g) in at
    least two out of three first morning voids with ≥ 30% increase (geometric
    mean) in UACR from "run-in" period samples OR > 40mg/g
    (geometric mean).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 13 weeks and at planned end (July to September 2018) or early
    termination (treatment group)
    Every 52 weeks and at planned end (July to September 2018) or early
    termination (observational group)
    E.5.2Secondary end point(s)
    In the following paragraphs patients in the intervention group, (group B)
    and observation group (group A) will be compared
    1) Comparison of composite fatal and non-fatal cardiovascular outcome
    (MI, stroke, CABG, PTCA, hospitalization for heart failure and CVD), and
    all cause mortality during the study
    2) Comparison of incidence of retinopathy and frequency of laser
    treatment. Data collected from self-reported AEs
    3) In addition to the categorical analysis of urinary albumin excretion,
    an analysis will be performed with changes in geometric mean
    albuminuria throughout the study period in all patients by assessing the
    slope of albuminuria changes and absolute changes from inclusion to
    end of trial
    4) Development of microalbuminuria (UACR >30 mg/g) in at least one
    morning void urine sample will be used as a secondary outcome instead
    of confirmed microalbuminuria
    5) Development of macroalbuminuria (UACR >300 mg/g) in 2 out 3 first
    morning void urine samples)
    6) For patients with eGFR ≥ 60 at baseline, development of eGFR<60
    ml/min/1.73m2.
    7) Change in eGFR (slope and absolute from baseline and from 3 month
    post-baseline to end of study)
    In the following paragraphs patients receiving active medication will be
    compared to placebo treatment.
    8) Comparison of composite fatal and non-fatal cardiovascular outcome
    (MI, stroke, CABG, PTCA, hospitalization for heart failure and CVD) and
    all cause mortality during the study
    9) Comparison of incidence of retinopathy and frequency of laser
    treatment. Data collected from AEs
    XML File Identifier: LgutIXPCxi8i48QEjl8hMnUOCpU=
    Page 12/22
    10) Development of microalbuminuria (UACR > 30 mg/g) in at least one
    morning void urine sample will be used as a secondary outcome instead
    of con-firmed microalbuminuria
    11) Development of macroalbuminuria (UACR > 300 mg/g in 2 out 3 first
    morning void urine samples)
    12) For patients with eGFR ≥ 60 at baseline, development of eGFR<60
    ml/min/1.73m2
    13) Change in eGFR (slope and absolute from baseline and from 3 month
    post-baseline to end of study)
    14) Assessment of safety
    The assessment of safety will be based primarily on the frequency of
    eCRF-documented AEs, laboratory abnormalities, and SAEs. Occurrence
    and frequency of eCRF-documented AEs, SAEs and laboratory
    abnormalities will be summarized by treatment group.
    In addition AEs leading to death and AEs leading to discontinuation of
    study medication and/or withdrawal will be summarized for the two
    treatment groups
    E.5.2.1Timepoint(s) of evaluation of this end point
    1), 3), 8) during the study
    2), 9) Data collected from self-reported AEs
    4), 5), 10), 11) run-in period, every 13 weeks, at planned end (July to
    September 2018) or early termination (treatm. group), run-in period,
    every 52 weeks, at planned end (Jul to Sep 2018) or early termination
    (obs. group)
    6),12) screening/baseline, Visit 1, every 13 weeks, at planned end or
    early termination (treatm. group); every 52 weeks and at planned end
    or early termination (obs. group)
    7), 13) baseline, every 13 weeks and at planned end or early termination
    (treatm. group); every 52 weeks and at planned end or early
    termination (obs. group)
    14) baseline, every Visit, prolonged until all AEs are resolved or until the
    investigator assess the adverse events as "chronic" or "stable".
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    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 Yes
    E.6.13.1Other scope of the trial description
    Predictive value of the urinary proteomics test in regards to renal and cardiovascular events
    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) Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Randomized, double blind, placebo-control trial and prospective observational study
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Czech Republic
    Denmark
    Germany
    Greece
    Italy
    Macedonia, the former Yugoslav Republic of
    Netherlands
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 660
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1340
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1700
    F.4.2.2In the whole clinical trial 2000
    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)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-29
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