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    Summary
    EudraCT Number:2012-000654-55
    Sponsor's Protocol Code Number:CVD-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-11
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-000654-55
    A.3Full title of the trial
    Spironolactone to Prevent Cardiovascular Events in Early Stage Chronic Kidney Disease (CKD): A Pilot Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Spironolactone to Prevent Cardiovascular Events in Early Stage Chronic Kidney Disease
    A.3.2Name or abbreviated title of the trial where available
    STOP-CKD
    A.4.1Sponsor's protocol code numberCVD-001
    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 SponsorUniversity of Birmingham
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham
    B.5.2Functional name of contact pointKhai Ping Ng
    B.5.3 Address:
    B.5.3.1Street AddressUniversity of Birmingham
    B.5.3.2Town/ cityBirmingham
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number07830818312
    B.5.6E-mailkhaiping@doctors.org.uk
    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 Yes
    D.2.1.1.1Trade name Spironolactone
    D.2.1.1.2Name of the Marketing Authorisation holderMetwest Pharmaceuticals, 15 Runnelfield, Harrow HA1 3NY
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSpironolactone
    D.3.9.4EV Substance CodeAS1
    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 placeboCapsule
    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
    chronic kidney disease
    E.1.1.1Medical condition in easily understood language
    chronic kidney disease
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Patients with reduced kidney function (kidney disease) have high rates of hardening of the blood vessels, which leads to early heart disease and strokes. Previous research has shown that using low dosage of a 'water tablet', spironolactone in patients with early kidney disease in a hospital outpatient setting improved heart structure and function as well as reduced blood vessel stiffness.

    STOP-CKD study aims to determine if blood vessel stiffness can be safely reduced with the use of low dose spironolactine in people with early stage kidney disease managed at general practices.
    E.2.2Secondary objectives of the trial
    The study also aims to examine:
    1. Rate of side effects and safety of the use of spironolactone in people with early stage kidney disease.
    2. Patients' and health care professionals’ views to kidney disease, the use of spironolactone in people with early stage kidney disease in a primary care setting as well as their views to research study in the primary care.
    3. Recruitment rate of participants to the study.

    In addition to addressing the above questions, this pilot study (small scale preliminary study) is to test the feasibility of a full-scale definitive study to determine whether cardiovascular events might be safely be reduced with the use of spironolactone in addition to standard management of early stage kidney disease in primary care setting.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age over 18 years
    2. Diagnosis of CKD Stage 3 (eGFR 30-59 ml/min/1.73m2) using the MDRD (Modification of Diet in Renal Disease) equation.
    E.4Principal exclusion criteria
    •Diabetes Mellitus
    •Terminal disease or felt otherwise unsuitable by their general practitioner (GP)
    •Chronic heart failure i.e. a clinical diagnosis or known ejection fraction (EF) <55%
    •Atrial fibrillation
    •Alcohol or drug abuse
    •Inability to comply with trial medication and follow-up
    •Documented previous hyperkalaemia or intolerance of spironolactone
    •Documented Addison’s disease and/or on fludrocortisone
    •Severe hypertension: blood pressure ≥ 180/110 mmHg
    •Systolic blood pressure less than 120mmHg
    •Recent acute kidney injury or hospital admission (within past 6 weeks)
    •Chronic diarrhoea
    •Pregnancy
    •ACR>70 mg/mmol (will require specialist referral if not already made)
    •Serum potassium ≥ 5 mmol/L on screening blood test
    •Concomitant co-trimoxazole medication
    •Concomitant angiotensin-converting enzyme inhibitor AND angiotensin II receptor blocker medication
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for the study is the change of pulse wave velocity (measurement of arterial stiffness).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline (at commencement of trial medication)
    2. At week 40 (40 weeks after commencement of trial medication). Trial medication will be stopped at week 40.
    3. At 46 week (6 weeks after stopping the trial medication)
    E.5.2Secondary end point(s)
    The secondary end points are:
    •Change in blood pressure
    •Change in estimated Glomerular Filtration Rate (eGFR)
    •Change in urinary albumin to creatinine ratio (ACR)
    •Change of pulse wave characteristics
    •Incidence of hyperkalaemia
    •Incidence of hypotension (<100mmHg or >20mmHg systolic drop on standing)
    •Incidence of side-effects
    •Incidence of other adverse events or adverse reaction defined by the Medicines
    and Healthcare products Regulatory Agency (MHRA)
    •Health status as measured by EQ5D

    Subgroup study will also examine:
    •Difference in serum potassium reading using two different methods of transport and analysis
    •Qualitative data outcome on patients’ and primary care physicians’ attitudes towards spironolactone in CKD in community setting and the potential barriers exist to its use.
    •Qualitative data outcome on patients’ attitudes to CKD and research in CKD in a community setting and the potential barriers exist for participation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoints of evaluation of all these end points are at baseline, week 40 and week 46. There will also be continuous evaluation of the incidence of hyperkalaemic, hypotension, side effection of trial medication and other adverse events or reactions throughtout the study period.



    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 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 concerned10
    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
    LVLS
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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.1.1Number 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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state240
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 240
    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)
    At 40 weeks after randomisation, all participants will stop taking the study medication. All participants will continue with their routine care with the general practitioners.
    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 Decision2012-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-05-19
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