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    Summary
    EudraCT Number:2020-000433-40
    Sponsor's Protocol Code Number:NL72836.340.10
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-08-03
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-000433-40
    A.3Full title of the trial
    Treatment of vascular stiffness in patients with autosomal dominant polycystic kidney disease
    Behandeling van vaatstijfheid bij patiënten met autosomaal dominante polycysteuze nierziekte
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of stiffness in blood vessels in patients with familial cystic kidney disease
    Behandeling van stijfheid in bloedvaten bij patiënten met familiaire cystenieren
    A.3.2Name or abbreviated title of the trial where available
    TRAMPOLINE
    TRAMPOLINE
    A.4.1Sponsor's protocol code numberNL72836.340.10
    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 SponsorErasmus University Medical Centre Rotterdam
    B.1.3.4CountryNetherlands
    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 supportThe Dutch Kidney Foundation
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus University Medical Centre Rotterdam
    B.5.2Functional name of contact pointPrincipal investigator
    B.5.3 Address:
    B.5.3.1Street AddressWytemaweg 80
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015CN
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031107040704
    B.5.6E-mailm.salih@erasmusmc.nl
    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 Amiloride
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameAmiloride
    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 INNAMILORIDE
    D.3.9.1CAS number 2609-46-3
    D.3.9.4EV Substance CodeSUB05433MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 Sodium Chloride
    D.2.1.1.2Name of the Marketing Authorisation holderAlturix Limited
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Capsule
    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 INNSodium chloride
    D.3.9.3Other descriptive nameSodium Chloride
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    D.3.11.13.1Other medicinal product typeFood supplement
    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
    Autosomal dominant polycystic kidney disease
    Autosomaal dominante polycysteuze nierziekte
    E.1.1.1Medical condition in easily understood language
    Cystic kidney disease
    Cystenieren
    E.1.1.2Therapeutic area Not possible to specify
    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
    The main goal of this study is to determine if arterial stiffness is exacerbated due to a high-salt diet in patients with ADPKD.
    Het hoofddoel van deze studie is om aan te tonen of arteriële vaatstijfheid afhankelijk is van een hoog-zout dieet bij patiënten met ADPKD.
    E.2.2Secondary objectives of the trial
    The second goal is to determine whether treatment with amiloride prevents the effects of a high-salt diet.
    Het tweede doel is om te onderzoeken of amiloride het effect van een hoog-zout dieet teniet kan doen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    • Adults with ADPKD diagnosis based on Ravine criteria and/or with PKD1 or PKD2 mutation
    • CKD-EPI eGFR ≥ 60 ml/min/1.73m2
    • Ability to provide informed consent
    Inclusie criteria:
    • Volwassenen met de diagnose ADPKD, gebaseerd op de Ravine criteria en/of een PKD1 of PKD2 mutatie
    • CKD-EPI eGFR ≥ 60 ml/min/1.73m2
    • Vermogen om informed consent te geven
    E.4Principal exclusion criteria
    Exclusion criteria:
    - Uncontrolled hypertension, defined as an office blood pressure of ≥160/ ≥90 mmHg with or without antihypertensive treatment
    - Concomitant use of ≥3 antihypertensive medications
    - Serum potassium levels >5.5 mmol/L (measured within last 6 months)
    - History of liver disease (excluding liver cysts due to ADPKD)
    - History of heart failure (cardiac ejection fraction < 35%) or cardiac arrhythmia
    - History of diabetes mellitus
    - Active infection or antibiotic therapy
    - Immunosuppressive therapy within the last year
    - Concomitant use of drugs that could influence blood pressure and/or disease progression (Tolvaptan/non-steroidal anti-inflammatory drugs (NSAIDs)/chemotherapy), excluding <3 antihypertensive drugs
    - Actual pregnancy or unwillingness to adhere to reproductive precautions during the duration of the study
    Exclusie criteria:
    - Niet goed behandelde hypertensie, gedefinieerd als een spreekkamer bloeddruk van ≥160/ ≥90 mmHg met/zonder antihypertensiva
    - Gebruik van ≥3 antihypertensive medicaties
    - Serum kalium gehalte van >5.5 mmol/L (gedurende de laatste 6 maanden)
    - Leverfalen (exclusief lever cysten door ADPKD)
    - Hartfalen (ejectie fractie < 35%) of hartritmestoornissen
    - Diabetes mellitus
    - Actieve infectie of antibiotica gebruik
    - Gebruik van immunosuppressiva gedurende het laatste jaar
    - Gebruik van medicatie dat bloeddruk of ziekte progressie van ADPKD beïnvloedt (Tolvaptan/NSAIDs/chemotherapie), behalve <3 antihypertsive medicaties
    - Actueel zwangerschap of onwil tot het nemen van anticonceptie maatregelen gedurende gehele studie
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of this study is a treatment group difference in non-invasively measured central PWV with or without high-salt diet.
    De primaire uitkomst van deze studie is het groepsverschil van non-invasief gemeten arteriële vaatstijfheid met of zonder hoog-zout dieet.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 3, week 5 and at the end of the study
    In week 3, week 5 en op het eind van de studie
    E.5.2Secondary end point(s)
    Secondary outcomes include ambulatory (24-hour) blood pressures, markers of inflammation, salt tasting test and skin sodium content through 23Na-MRI.
    Secundaire uitkomstmaten zijn 24-uurs bloeddruk meting, markers van inflammatie, zoutsmaak gevoeligheidstesten en zoutopslag in de huid gemeten met 23Na-MRI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 3, week 5 and at the end of the study
    In week 3, week 5 en op het eind van de studie
    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 No
    E.6.5Efficacy No
    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 Yes
    E.8.1.7.1Other trial design description
    Een dubbelblinde, gerandomiseerde placebo gecontroleerde trial met open-label amiloride behandeling
    A double blinded, randomized placebo controlled trial with open-label treatment with amiloride
    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
    LVLS
    Laatste visite van de laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state54
    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
    Geen
    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 Decision2021-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-30
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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