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    Summary
    EudraCT Number:2017-000213-23
    Sponsor's Protocol Code Number:NL60561.078.17
    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:2017-03-01
    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 number2017-000213-23
    A.3Full title of the trial
    ARNI-study: ARNI or ARB to arrest progression of nephropathy.
    ARNI-studie: ARNI of ARB ter voorkoming voortgang chronische nierschade.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dual treatment for patients with chronic kidney disease, high blood pressure and diabetes.
    Combinatiebehandeling voor chronische nierschade bij hoge bloeddruk en diabetes.
    A.3.2Name or abbreviated title of the trial where available
    ARNI-study
    ARNI-studie
    A.4.1Sponsor's protocol code numberNL60561.078.17
    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 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 Entresto
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm 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 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.IMP: 2
    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 Valsartan
    D.2.1.1.2Name of the Marketing Authorisation holderPharmachemie 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.3.4Pharmaceutical 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic kidney disease with concurrent hypertension and diabetes.
    Chronische nierinsufficientie bij hypertensie en diabetes mellitus.
    E.1.1.1Medical condition in easily understood language
    Chonic kidney disease with concurrent high blood pressure and diabetes.
    Chronische nierschade bij hoge bloeddruk en suikerziekte.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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 antiproteinuric effect of sacubitril/valsartan and valsartan in patients with stage 3 or stage 4 CKD, with concurrent hypertension and diabetes.
    Het vergelijken van het antiproteinurische effect van sacubitril/valsartan en valsartan in patiënten met chronische nierinsufficientie, hypertensie en diabetes mellitus.
    E.2.2Secondary objectives of the trial
    To compare the effects on ambulatory blood pressure, eGFR, number of AEs and SAEs, parameters of kidney damage, renin-angiotensin-aldosterone system and natriuretic peptide system.
    Het vergelijken van het effect op ambulante bloeddruk, eGFR, aantal AEs en SAEs, parameters van nierschade, renine-angiotensine-aldosteron systeem en natriuretisch peptide systeem.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age > 18 years
    • Chronic kidney disease stage 3 or 4 (eGFR 15-60 ml/min/1.73m2)
    • Residual proteinuria during RAAS blockade (≥ 1 g/day)
    • Diabetes mellitus type 2
    • Hypertension (office systolic blood pressure > 140 mmHg OR use of any anti-hypertensive drug)
    Leeftijd > 18 jaar
    • Chronische nierinsufficientie stadium 3 of 4 (eGFR 15-60 ml/min/1.73m2)
    • Resterende proteinuria onder RAAS blokkade (≥ 1 g/day)
    • Diabetes mellitus type 2
    • Hypertensie (spreekkamer systolische bloed druk > 140 mmHg OF use of gebruik van antihypertensieve medicatie)
    E.4Principal exclusion criteria
    • SBP >180 mmHg at screening
    • Not possible to withdraw ACEi or ARB
    • Known intolerance or contraindication for ARB
    • History of angioedema
    • Nephrotic syndrome
    • Rapidly declining kidney function with high likelihood of dialysis or transplantation in the coming 4 months
    • Use of immunosuppressive drugs
    • Kidney transplant recipients
    • Pregnant or breastfeeding women
    • Life expectancy < 6 months
    • Inability to adhere to study protocol (due to language, incapacitated subjects, subjects with intellectual disability)
    • Systolische bloeddruk >180 mmHg bij screening
    • Niet mogelijk om ACEi of ARB te stoppen
    • Bekende intolerantie of contraindicatie voor ARB
    • Voorgeschiedenis van angio-oedeem
    • Nephrotisch syndroom
    • Snel le achteruitgang nierfunctie waarvoor waarschijnlijk niertransplantatie nodig in de komende 4 maanden
    • Gebruik van immunosuppressiva
    • Niertransplantaat ontvangers
    • Vrouwen die zwanger zijn of borstvoeding geven
    • Levensverwachting < 6 maanden
    • Onvermogen om het studieprotocol na te leven (door taalgebreken, verminderd bewustzijn, intellectuele achterstand)
    E.5 End points
    E.5.1Primary end point(s)
    To compare the reduction in 24-hour proteinuria of sacubitril/valsartan or valsartan in patients with stage 3 or stage 4 CKD, with concurrent hypertension and diabetes.
    Het vergelijken van antiproteinurische effect van sacubitril/valsartan en valsartan in patiënten met chronische nierinsufficientie, hypertensie en diabetes mellitus.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    Niet van toepassing
    E.5.2Secondary end point(s)
    Effects on ambulatory blood pressure, eGFR, number of AEs and SAEs, parameters of kidney damage, renin-angiotensin-aldosterone system and natriuretic peptide system.
    Het vergelijken van het effect op ambulante bloeddruk, eGFR, aantal AEs en SAEs, parameters van nierschade, renine-angiotensine-aldosteron systeem en natriuretisch peptide systeem.
    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 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 Yes
    E.8.1.3Single blind No
    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) Yes
    E.8.2.2Placebo No
    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 bezoek van laatste deelnemer.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 21
    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 state31
    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 Decision2017-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-21
    P. End of Trial
    P.End of Trial StatusOngoing
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