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    Summary
    EudraCT Number:2017-000656-26
    Sponsor's Protocol Code Number:BAY1142524/18933
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-10-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-000656-26
    A.3Full title of the trial
    A randomized, double-blind, multicenter study to assess the efficacy and safety of a 6 month oral treatment with the chymase inhibitor BAY 1142524 at a dose of 25 mg BID in comparison to placebo on top of standard of care in patients with type II diabetes and a clinical diagnosis of diabetic kidney disease
    Estudio aleatorizado, doble ciego, multicéntrico para valorar la eficacia y seguridad de 6 meses de tratamiento oral con el inhibidor de quimasa BAY 1142524 a dosis de 25mg dos veces al día en comparación con placebo añadido a la medicación habitual de pacientes con diabetes tipo II clínicamente diagnosticados de nefropatía diabética.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Chymase inhibitor BAY 1142524 in patients with type II diabetes and a clinical diagnosis of diabetic kidney disease
    Inhibidor de quimasa BAY 1142524 en pacientes con diabetes tipo II clínicamente diagnosticados de nefropatía diabética
    A.4.1Sponsor's protocol code numberBAY1142524/18933
    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 SponsorBayer AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer clinical Trails Contact
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number0034.900102372
    B.5.5Fax numbern.a.n.a.n.a.n.a.
    B.5.6E-mailclinical-trails-contact@bayer.com
    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 No
    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 nameBAY 1142524 25 mg Tablets
    D.3.2Product code BAY 1142524 25 mg Tablets
    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 INNnot assigned
    D.3.9.1CAS number not assigned
    D.3.9.2Current sponsor codeBAY 1142524
    D.3.9.3Other descriptive nameBAY 1142524
    D.3.9.4EV Substance CodeSUB126182
    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
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Type II diabetic mellitus (T2DM) patients with a clinical diagnosis of diabetic kidney disease (CKD)
    Pacientes con diabetes mellitus tipo II (DMT2) con diagnóstico clínico de nefropatía diabética (ND)
    E.1.1.1Medical condition in easily understood language
    Type II diabetic patients with a diabetic kidney disease
    Pacientes con diabetes tipo II con nefropatía diabética
    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
    Investigate the change in UACR from baseline values obtained at Visit 1 to 6 months after treatment with BAY 1142524, in comparison to placebo, on top of standard of care therapy.
    Investigar el cambio en el cociente albumina/creatinina en orina (UACR, por sus siglas en inglés) desde los valores iniciales obtenidos en la Visita 1 hasta 6 meses después del tratamiento con BAY 1142524 en comparación con placebo añadido a la medicación habitual.
    E.2.2Secondary objectives of the trial
    Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events
    El objetivo secundario es el análisis de seguridad y tolerabilidad definido por la incidencia y gravedad de los acontecimientos adversos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with T2DM and a clinical diagnosis of DKD (as judged by the investigator) treated with at least the minimal recommended dose of an ARB or an ACEI (according to international or local guidelines) – but not with both simultaneously – for at least 3 months prior to the screening visit without any adjustments to this therapy for at least 4 weeks prior to the screening visit
    2. UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit
    3. eGFR >= 30 mL/min/1.73 m2 and <90 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit
    1. Pacientes con DMT2 diagnosticados clínicamente de ND (a criterio del investigador) tratados con al menos la dosis mínima recomendada de un BRA o IECA (según las directrices internacionales o locales) pero no con ambos de forma simultánea, durante al menos 3 meses antes de la visita de selección sin realizar ningún ajuste en este tratamiento durante al menos 4 semanas antes de la visita de selección.
    2. UACR > 50 mg/g y < 3000 mg/g en 2 de 3 muestras de orina de la mañana consecutivas en la visita de selección y en la visita inicial.
    3. TFGe >= 30 ml/min/1,73 m2 y < 90 ml/min/1,73 m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD EPI]) en la visita de selección y en la visita inicial.
    E.4Principal exclusion criteria
    1. Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator
    2. Known bilateral clinical relevant renal artery stenosis (>75%)
    3. New York Heart Association (NYHA) Class IV
    4. Acute kidney injury or dialysis within the last 3 months before the screening visit
    5. Renal replacement therapy during study conduct
    6. Renal allograft in place or a scheduled kidney transplant during study conduct
    7. Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit
    8. Clinically relevant hepatic dysfunction
    9. Uncontrolled hypertension as evidenced by systolic blood pressure >180 mmHg, diastolic blood pressure >110 mmHg (mean of triplicate values at the screening or baseline visit after at least 10 minutes rest in sitting position)
    1. Nefropatía no diabética en caso de ser el principal diagnóstico que contribuye a la nefropatía crónica (NC), según el criterio del investigador.
    2. Diagnóstico de estenosis de la arterial renal bilateral clínicamente significativa (> 75 %).
    3. Clase IV de la New York Heart Association (NYHA).
    4. Lesión renal aguda o diálisis en los 3 últimos meses previos a la visita de selección.
    5. Terapia renal sustitutiva durante el transcurso del estudio.
    6. Aloinjerto renal realizado o trasplante renal programado durante el transcurso del estudio.
    7. Ictus, accidente cerebral isquémico transitorio, síndrome coronario agudo u hospitalización por insuficiencia cardíaca en los 3 últimos meses previos a la visita de selección.
    8. Disfunción hepática clínicamente relevante.
    9. Hipertensión no controlada definida por una presión arterial sistólica > 180 mmHg y una presión arterial diastólica > 110 mmHg (media de los valores triplicados en la visita de selección o la visita inicial después de al menos 10 minutos en reposo en posición sentada).
    E.5 End points
    E.5.1Primary end point(s)
    Ratio of UACR at Visit 6 (167 ±14 days after Visit 1) to UACR at Visit 1
    Valor del UACR en la Visita 6 (167 ± 14 días después de la Visita 1) hasta el UACR en la Visita 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    UACR will be assessed before the start of treatment with study drug (Visit 1) and after 6 months of treatment with study drug (Visit 6) for the primary variable.
    El UACR se evaluará antes del inicio del tratamiento con el fármaco del estudio (Visita 1) y después de 6 meses de tratamiento con el fármaco del estudio (Visita 6) para la variable principal.
    E.5.2Secondary end point(s)
    Safety and tolerability
    Seguridad y tolerabilidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    Last Visit of the Last Subject
    Última visita del último sujeto
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker and Tolerability
    Biomarcador y Tolerabilidad
    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 No
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Denmark
    Finland
    Israel
    Italy
    Spain
    Sweden
    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
    LVLS
    Última visita del último sujeto
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.1.1In 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 107
    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
    Ninguno
    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 Decision2018-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-10
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