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    Summary
    EudraCT Number:2012-002672-13
    Sponsor's Protocol Code Number:RH/BARACKD/0003
    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:2013-03-19
    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 number2012-002672-13
    A.3Full title of the trial
    Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) Trial: a prospective randomised open blinded endpoint trial to determine the effect of aldosterone receptor antagonism on mortality and cardiovascular outcomes in patients with stage 3b chronic kidney disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Establishing the benefits of a tablet commonly used to treat raised blood pressure in people with Chronic Kidney Disease stage 3b.
    A.3.2Name or abbreviated title of the trial where available
    BARACK D
    A.4.1Sponsor's protocol code numberRH/BARACKD/0003
    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 Oxford, Clinical Trials and Research Governance Office
    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 supportNational Institute for Health Research School for Primary Care Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Primary Care Health Sciences, University of Oxford
    B.5.2Functional name of contact pointBen Thompson
    B.5.3 Address:
    B.5.3.1Street AddressPrimary Care Clinical Trials Unit
    B.5.3.2Town/ city23-38 Hythe Bridge Street
    B.5.3.3Post codeOX1 2ET
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865289296
    B.5.6E-mailBen.Thompson@phc.ox.ac.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 (Non-proprietary)
    D.2.1.1.2Name of the Marketing Authorisation holderN/A (Proprietary version is Pfizer)
    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.3.2Product code 0025-1001
    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.3.9.4EV Substance CodeAS1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    We plan a large pragmatic trial to test the potential for spironolactone to to reduce overall cardiovascular events and death, to delay the decline in renal function, and to improve surrogate markers for vascular disease in people with stage 3b (eGFR 30-44 ml/min/1.73m2)Chronic Kidney Disease.
    E.1.1.1Medical condition in easily understood language
    Chronic kidney disease (stage 3b)
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10018355
    E.1.2Term Glomerular filtration rate
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10007648
    E.1.2Term Cardiovascular disease, unspecified
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of aldosterone receptor antagonism on mortality and cardiovascular outcomes (onset or progression of cardiovascular disease) in patients with stage 3b CKD.
    E.2.2Secondary objectives of the trial
    To determine the effect of aldosterone receptor antagonism in patients with stage 3b CKD on:
    1. Measures of cardiovascular haemodynamics
    2. Left ventricular function
    3. Decline in renal function
    4. Treatment costs and benefits
    5. Incidence of TIA
    6. To determine the safety of ARA in patients with stage 3b CKD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participant is willing and able to give informed consent for participation in the study.
    • Male or Female, aged 18 years or above.
    • Evidence of stage 3b CKD using the MDRD equation. This includes patients on the CKD register undergoing annual monitoring who have had 2 or more recent samples in the 3b range. as well as patients with at least two consecutive blood samples within the preceding 12 months (with a minimum of 6 weeks between tests) and no identifiable reason for a temporary reduction in eGFR. Where only one test has been performed and is in the 3b range, GPs will be reminded that standard care suggests a second confirmatory test.
    • Able (in the recruiting GP’s opinion) and willing to comply with all study requirements.
    • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
    • Willing to provide contact details to the Research Team, for use at any time should the need arise, on trial related matters.
    • If the participant is a female of child-bearing potential, they are willing to ensure effective contraception during the trial period.
    E.4Principal exclusion criteria
    • Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
    • Type 1 diabetes mellitus
    • Terminal disease or felt otherwise unsuitable by their GP.
    • Chronic heart failure clinical diagnosis or known LVSD with EF<40%.
    • Recent myocardial infarction (within 6 months).
    • Alcohol or drug abuse.
    • Suspected or known current hazardous or harmful drinking, as defined by an alcohol intake of greater than 42 units every week.
    • Suspected or known current substance misuse.
    • Documented previous hyperkalaemia not thought to be spurious, or intolerance of spironolactone.
    • Serum potassium at baseline over 5 mmol/L.
    • Documented Addisonian crisis and/or on fludrocortisone.
    • Documented symptomatic hypotension or baseline systolic blood pressure under 100mmHg.
    • Recent acute kidney injury or admission for renal failure.
    • ACR > 70 mg/mmol.
    • Prescription of medications with known harmful interactions with spironolactone as documented in the British National Formulary including tacrolimus, lithium and cyclosporine.
    • Any other significant disease or disorder which, in the opinion of the recruiting GP, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Composite of death or first onset or hospitalisation for heart disease (coronary heart disease, arrhythmia, new onset/first recorded atrial fibrillation, sudden death, failed sudden death), stroke, or heart failure at 3 years. Primary end-points will be adjudicated by an independent end-points committee blinded to treatment arm.
    E.5.1.1Timepoint(s) of evaluation of this end point
    An evaluation of whether the primary outcome has been met will be performed at each trial visit by the member of the research team performing that visit.
    E.5.2Secondary end point(s)
    • Change in carotid-femoral pulse wave velocity from baseline to final visit – intensively phenotyped group.
    • Change in blood pressure at final visit and annually
    • Rates of hypotension (<100mmHg systolic or >20 mmHg systolic drop on standing)
    • Mean change in ambulatory blood pressure from randomisation to final visit (measured in mmHg) – intensively phenotyped group.
    • Changes in BNP.
    • Change in ACR
    • Changes in eGFR
    • Change in health status on EQ-5D-5L
    • Cost effectiveness analysis
    • Transient Ischaemic Attack – as defined by the American Heart Association (2009)
    • Rates of adverse events
    o Rates of hyperkalaemia
    E.5.2.1Timepoint(s) of evaluation of this end point
    Due to the nature of the analysis of the secondary endpoints, which requires all results to have been collected, the evaluation will take place once all visits are complete.
    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 Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    A prospective randomised open blinded endpoint (PROBE) trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard Treatment
    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 concerned120
    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 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
    The end of trial will be defined as the date of the last visit for the last patient for the initial 3 year follow-up period.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 616
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2000
    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 state2616
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2616
    F.4.2.2In the whole clinical trial 2616
    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)
    No arrangements have been made. However spironolactone is an inexpensive drug and if shown to be of benefit could be expanded into routine care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Primary Care Research Network
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-09
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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