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    Summary
    EudraCT Number:2021-003053-37
    Sponsor's Protocol Code Number:21952
    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:2021-11-12
    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 number2021-003053-37
    A.3Full title of the trial
    A non-blinded retrospective biomarker add-on study to FIGARO-DKD for Bioprofiling the pharMacodynamic response to finerenone in FIGARO-DKD subjects (FIGARO-BM)
    Estudio de biomarcadores complementario, abierto y retrospectivo para evaluar la respuesta farmacodinámica de Finerenona en los pacientes del estudio FIGARO-DKD (FIGARO-BM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A non-blinded retrospective biomarker add-on study to FIGARO-DKD for Bioprofiling the pharMacodynamic response to finerenone in FIGARO-DKD subjects (FIGARO-BM)
    Estudio de biomarcadores complementario, abierto y retrospectivo para evaluar la respuesta farmacodinámica de Finerenona en los pacientes del estudio FIGARO-DKD (FIGARO-BM)
    A.3.2Name or abbreviated title of the trial where available
    FIGARO-BM
    NA
    A.4.1Sponsor's protocol code number21952
    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 Trials 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 number004930300139003
    B.5.6E-mailclinical-trials-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 nameFinerenone
    D.3.2Product code BAY 94-8862 IR tablet 10 mg
    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 INNFinerenone
    D.3.9.1CAS number 1050477-31-0
    D.3.9.2Current sponsor codeBAY 94-8862
    D.3.9.4EV Substance CodeSUB30924
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboCoated 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 Diabetes Mellitus and Diabetic Kidney Disease
    Diabetes Mellitus tipo II y enfermedad renal crónica
    E.1.1.1Medical condition in easily understood language
    Type II Diabetes Mellitus and Diabetic Kidney Disease
    Diabetes Mellitus tipo II y enfermedad renal crónica
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061835
    E.1.2Term Diabetic nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study aims to investigate long-term effect of finerenone treatment, in addition to standard-of-care, on circulating blood biomarkers associated with fibrosis, congestion, inflammation and vascular function.
    Investigar el efecto a largo plazo del tratamiento con Finerenona, sumado al
    tratamiento estándar, sobre los biomarcadores sanguíneos circulantes asociados a la fibrosis, la congestión, la inflamación y la función vascular
    E.2.2Secondary objectives of the trial
    To characterize mid- to long-term PD effects of finerenone and profiling the response to finerenone (vs placebo) in patients with DKD to describe biological pathways.
    Caracterizar a medio-largo plazo los efectos PD de finerenona y el perfil de respuesta de finerona (vs placebo) en pacientes con DKD para describir los mecanismo biológicos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed informed consent to participate in FIGARO-BM
    • Randomized in the FIGARO-DKD trial
    • For each participant, PK plasma samples from Visit 3 and at least 2 other Visits (Visit 5, Visit 8, Visit 11) must be available on storage from the main study FIGARO-DKD
    Consentimiento informado firmado para participar en FIGARO-BM
    • Aleatorizados en el ensayo FIGARO-DKD
    • De cada participante, se debe disponer de muestras almacenadas de plasma para FC de la visita 3 y al menos otras 2 visitas (visita 5, visita 8, visita 11) del estudio principal FIGARO-DKD
    E.4Principal exclusion criteria
    Subjects which did not show overall compliance of 80 to 120% with study intervention in FIGARO-DKD
    • Subjects which were not part of the full analysis set (FAS) of FIGARO-DKD.
    • Subjects with known fatal outcome
    Subjects with baseline eGFR ≤25 mL/min/1.73m2
    • Subjects with low baseline risk (normal albuminuria and eGFR≥60 mL/min/1.73m2)
    Sujetos que no mostraron un cumplimiento general del 80 % al 120 % con la intervención del estudio en FIGARO-DKD
    • Sujetos que no formaron parte del grupo completo de análisis (GCA) de FIGARO-DKD.
    • Sujetos con desenlace mortal conocido
    • Sujetos con TFGe basal ≤25 ml/min/1,73 m2
    • Sujetos con bajo riesgo basal (albuminuria normal y TFGe ≥60 ml/min/1,73 m2)
    E.5 End points
    E.5.1Primary end point(s)
    To investigate long-term effect of finerenone treatment, in addition to standard-of-care, on circulating blood biomarkers associated with fibrosis, congestion, inflammation and vascular function
    Investigar el efecto a largo plazo del tratamiento con Finerenona, sumado al
    tratamiento estándar, sobre los biomarcadores sanguíneos circulantes asociados a la fibrosis, la congestión, la inflamación y la función vascular
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change in plasma biomarker levels after 36 months (Visit 11) of treatment versus 4 months (Visit 3) of treatment in a set of 27 pre-defined biomarkers
    Cambio en los niveles de biomarcadores plasmáticos tras 36 meses (visita 11) de
    tratamiento frente a 4 meses (visita 3) de tratamiento en un conjunto de 27
    biomarcadores predefinidos
    E.5.2Secondary end point(s)
    To characterize mid- to long-term PD effects of finerenone and profiling the response to finerenone (vs placebo) in patients with DKD to describe biological pathways
    Caracterizar a medio-largo plazo los efectos PD de finerenona y el perfil de respuesta de finerona (vs placebo) en pacientes con DKD para describir los mecanismo biológicos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change in plasma biomarker levels after 12 months (Visit 5), 24 months (Visit 8) and 36 months (Visit 11) of treatment versus 4 months (Visit 3) of treatment
    Cambio en los niveles de biomarcadores plasmáticos tras 12 meses (visita 5), 24 meses (visita 8) y 36 meses (Visita 11) de tratamiento frente a 4 meses (visita 3) de tratamiento
    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 No
    E.6.6Pharmacokinetic No
    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 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 Yes
    E.8.1.7.1Other trial design description
    estudio retrospectivo complementario de biomarcadores al ensayo FIGARO DKD
    retrospective biomarker add-on study to FIGARO-DKD
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    Australia
    Brazil
    Canada
    Hong Kong
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    Singapore
    Taiwan
    United States
    Austria
    Belgium
    Bulgaria
    Denmark
    Finland
    Hungary
    Italy
    Netherlands
    Portugal
    Spain
    Sweden
    Czechia
    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
    The end of the study is defined as the date when the last subject provides consent into the study globally
    El fin del ensayo se define como la fecha en que el último paciente da su consentimiento informado a nivel global
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state74
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 325
    F.4.2.2In the whole clinical trial 600
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-31
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