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    Summary
    EudraCT Number:2011-003179-12
    Sponsor's Protocol Code Number:MN0511_1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-02
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-003179-12
    A.3Full title of the trial
    Mineralocorticoid Receptor antagonists in End stage reNal DiseAse
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacological blockade of the mineralocorticoid receptor in dialysis patients.
    A.3.2Name or abbreviated title of the trial where available
    MiREnDa
    A.4.1Sponsor's protocol code numberMN0511_1
    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 Hospital of Wuerzburg, Medical Director
    B.1.3.4CountryGermany
    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 supportGerman Federal Ministry for Education and Research (BMBF)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Wuerzburg
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressOberduerrbacher Str. 6
    B.5.3.2Town/ cityWuerzburg
    B.5.3.3Post code97080
    B.5.3.4CountryGermany
    B.5.4Telephone number+4993120143311
    B.5.5Fax number+49931201643311
    B.5.6E-mailhammer_f@klinik.uni-wuerzburg.de
    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 Spironolacton Hexal ®
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 CodeSUB10631MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number50
    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
    Hemodialysis
    E.1.1.1Medical condition in easily understood language
    Dialysis
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of the mineralocorticoid receptor antagonist spironolactone on left ventricular mass index in end stage renal disease patients on hemodialysis.
    E.2.2Secondary objectives of the trial
    To investigate the effect of spironolactone treatment on the following parameters/outcomes: cardiac function, serum potassium levels, blood pressure, hospitalization or death due to heart failure, kidney function, heart rate variability, cardiac arrhythmias, exercise capacity (6-minute walk test), vascular function (pulse wave analysis, flow-mediated dilatation, carotid intima-media thickness, carotid artery distensibility), body composition, quality of life and cardiovascular biomarkers, retinal capillary blood flow, retinal arteriolar wall structure
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written informed consent
    Age > 18 years
    Hemodialysis treatment for at least 3 months
    At least 3 dialysis sessions per week
    E.4Principal exclusion criteria
    Contraindications for cardiac magnet resonance imaging (CMR)
    Mineralocorticoid receptor antagonist treatment within the last 6 months
    Estimated life expectancy < 12 months as judged by the nephrologist
    History of hyperkalemia, defined as pre-dialysis potassium > 6.5 mmol/l occurring ≥ 3 times within the last 3 months prior to enrolment
    High risk to develop hyperkalemia defined as pre-dialysis potassium > 6.0 mmol/l
    Hypotension (systolic blood pressure < 100 mmHg)
    Planned kidney transplantation (living donor) within the prospected study duration
    Any acute illness within the last 4 weeks precluding a study participation as judged by the nephrologist
    Non-amenorrheic women with child bearing potential without reliable contraception, pregnancy/lactation
    Allergy/hypersensitivity to spironolactone
    Non-compliance suspected or demonstrated
    E.5 End points
    E.5.1Primary end point(s)
    Change in left ventricular mass index (LVMi) measured by cardiac MRI
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, after 9 months treatment.
    E.5.2Secondary end point(s)
    Cardiac function parameters (cardiac volumes, systolic and diastolic function, cardiac output) measured by CMR and echocardiography
    Pre-dialysis serum potassium levels
    Frequency of hyperkalemic episodes (potassium ≥ 6.5 mmol/l)
    Office and 24h blood pressure
    Clinical measures of heart failure severity (New York Heart Association (NYHA) functional class, 6 minute walk test)
    Cardiac death and/or hospitalization due to heart failure (combined endpoint)
    Residual kidney function (urine volume, creatinine-, urea-clearance, electrolyte excretion)
    Heart rate variability (ECG)
    Arterial stiffness (pulse wave analysis (PWA))
    Carotid intima media thickness (CIMT)
    Carotid artery distensibility (CD)
    Flow-mediated dilatation (FMD) of the brachial artery
    Body composition (bioimpedance spectroscopy)
    Biomarkers of fibrosis, inflammation and heart failure
    Quality of life
    Adherence to study medication
    retinal capillary blood flow, retinal arteriolar wall structure (scanning laser Doppler flowmetry)
    E.5.2.1Timepoint(s) of evaluation of this end point
    after a treatment duration of 9 months
    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) 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 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
    4-6 weeks after the last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 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 state120
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Germany Society of Nephrology (DGfN)
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
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