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    Summary
    EudraCT Number:2015-003637-96
    Sponsor's Protocol Code Number:NL54748.078.15
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-09-22
    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 number2015-003637-96
    A.3Full title of the trial
    DD-study: diet or diuretics for salt-sensitivity in chronic kidney disease
    DD-studie: dieet of diuretica tegen zoutgevoeligheid bij chronische nierinsufficientie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Salt restriction or water pills for hypertension in chronic renal disease
    Zoutbeperking of plastabletten voor hoge bloeddruk bij chronische nierschade
    A.3.2Name or abbreviated title of the trial where available
    DD-study
    DD-Studie
    A.4.1Sponsor's protocol code numberNL54748.078.15
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Moduretic
    D.2.1.1.2Name of the Marketing Authorisation holderMerck, Sharp & Dohme BV
    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 nameModuretic
    D.3.2Product code MSD 917
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Hypertension in chronic kidney disease
    Hypertensie bij chronische nierinsufficientie
    E.1.1.1Medical condition in easily understood language
    High blood pressure in patients with chronic kidney disease
    Hoge bloeddruk bij patiënten met chronische nierschade
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    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 compare the anti-hypertensive response to dietary salt restriction with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride in patients with chronic kidney disease stages 3 or 4.
    Het vergelijken van de antihypertensieve respons op zoutbeperking en de antihypertensieve respons op amiloride/hydrochloorthiazide bij patiënten met chronische nierinsufficientie in stadium 3 en 4.
    E.2.2Secondary objectives of the trial
    - To analyze the response in kidney parameters, the systemic and intra-renal renin-angiotensin system to the two interventions.
    - To compare the side-effects of the two interventions.
    - Analyseren van het effect van beide behandelingen op renale parameters, het systemische en het intrarenale renine-angiotensine systeem
    - Vergelijken van bijwerkingen van de twee interventies
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > 18 years.
    - Chronic kidney disease stage 3 or 4 (MDRD-GFR 15-60 ml/min)
    - Use of any anti-hypertensive drugs
    - No anti-hypertensive drugs but an average office systolic blood pressure > 140 mmHg (as measured by datascope)
    - Leeftijd >18 jaar
    - Chronische nierinsufficientie graad 3 of 4 (MDRD-GFR 15-60 ml/min)
    - Gebruik van antihypertensieve medicatie
    - Geen antihypertensieve medicatie, maar een gemiddelde systolische bloeddruk >140 mmHg (gemeten met datascope)
    E.4Principal exclusion criteria
    - Salt-wasting chronic kidney disease
    - Nephrotic syndrome
    - Pregnant or breastfeeding women
    - Life expectancy < 6 months
    - Severe heart failure (NYHA III or IV) or liver cirrhosis with ascites and the inability to withdraw diuretics
    - Rapidly declining kidney function with high likelihood of dialysis or kidney transplantation in the coming 4 months
    - Kidney transplant recipients
    - Use of immunosuppressive drugs
    - Use of non-steroidal anti-inflammatory drugs
    - Previous intolerance or allergy to hydrochlorothiazide or amiloride
    - Serum sodium < 135 mmol/l
    - Serum potassium < 3.5 mmol/l or > 5.0 mmol/l
    - Inability to adhere to the study protocol (due to language, incapacitated subjects, subjects with intellectual disability)
    - Salt-wasting nefropathie
    - Nefrotisch syndroom
    - Zwangerschap of vrouwen die borstvoeding geven
    - Levensverwachting <6 maanden
    - Ernstig hartfalen (NYHA III/IV) of levercirrose met ascites, zonder mogelijkheid om diuretica te stoppen
    - Snel afnemende nierfunctie met hoge kans op dialyse of niertransplantatie in de komende 4 maanden
    - Niertransplantatie-patienten
    - Gebruik van immunosuppressiva
    - Gebruik van NSAID's
    - Intolerantie of allergieen voor hydrochloorthiazide of amiloride
    - Serum natrium <135mmol/l
    - Serum kalium <3,5 mmol/l, of >5,0 mmol/l
    - Onvermogen om het studieprotocol na te leven (door taalgebreken, verminderd bewustzijn, intellectuele achterstand)
    E.5 End points
    E.5.1Primary end point(s)
    The study ends after 8 weeks (in which participants recieve both amiloride/hydrochlorothiazide and placebo). The primary end point is 24 hour ambulatory blood pressure.
    De studie eindigt na 8 weken (waarin deelnemers zowel amiloride/hydrochloorthiazide en placebo-behandeling ontvangen). De primaire uitkomstparameter is 24-uur bloeddruk, gemeten in de ambulante setting.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable.
    Niet van toepassing.
    E.5.2Secondary end point(s)
    - Number of AEs and SAEs.
    - Effects of the interventions on blood and urinary parameters (routine measurements, systemic and intrarenal renin-angiotensin-system, kidney injury markers, urinary exosomes)
    - Aantal bijwerkingen van beide interventies
    - Effecten van beide interventies op parameters in bloed en urine (routine bepalingen, systemische en intrarenaal renine-angiotensine systeem, neirschade parameters, exosomen in urine)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    Niet van toepassing.
    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 No
    E.6.4Safety No
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.2.3.1Comparator description
    Zout-arm dieet
    Sodium-restricted diet
    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 bezoek van de laatste deelnemer.
    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 months0
    E.8.9.1In the Member State concerned 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: 14
    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 state24
    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)
    If a subjects blood pressure response to amiloride/hydrochlorothiazide is more favourable than the response to sodium restriction, and subjects tolerate the drugs well, this medication could be continued after the study stops. Normally, the combination amiloride/hydrochlorothiazide is not prescribed to patients with chronic kidney disease in stages 3 or 4.
    Als de bloeddruk van een patient tijdens de studie beter reageert op amiloride/hydrochloorthiazide dan op zoutarm dieet, en patiënten verdragen de middelen goed, kan deze medicatie na het stoppen van de studie eventueel worden gecontinueerd. Normaal gesproken wordt amiloride/hydrochloorthiazide niet gebruikt bij patienten met chronische nierinsufficientie graad 3 of 4.
    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 Decision2015-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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