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    Summary
    EudraCT Number:2018-004651-20
    Sponsor's Protocol Code Number:402-C-1808
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-004651-20
    A.3Full title of the trial
    A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease
    Ensayo en Fase III Sobre la Eficacia y Seguridad del metilbardoxolona en Pacientes con Enfermedad Poliquística Renal Autosómica Dominante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease
    Ensayo en Fase III Sobre la Eficacia y Seguridad del metilbardoxolona en Pacientes con Enfermedad Poliquística Renal
    A.3.2Name or abbreviated title of the trial where available
    FALCON
    FALCON
    A.4.1Sponsor's protocol code number402-C-1808
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03918447
    A.5.4Other Identifiers
    Name:US IND numberNumber:140817
    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 SponsorReata Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportReata Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSERMES PLANIFICACION S.L
    B.5.2Functional name of contact pointSTART UP UNIT
    B.5.3 Address:
    B.5.3.1Street AddressCalle Rufino González, 14-2º D
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491327 50 25
    B.5.5Fax number+3491754 27 21
    B.5.6E-mailstart-up@sermescro.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 nameBardoxolone methyl 5 mg
    D.3.2Product code RTA 402
    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 INNBardoxolone Methyl
    D.3.9.1CAS number 218600-53-4
    D.3.9.2Current sponsor codeRTA 402
    D.3.9.3Other descriptive nameBARDOXOLONE METHYL
    D.3.9.4EV Substance CodeSUB33044
    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 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 nameBardoxolone methyl 10 mg
    D.3.2Product code RTA 402
    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 INNBardoxolone Methyl
    D.3.9.1CAS number 218600-53-4
    D.3.9.2Current sponsor codeRTA 402
    D.3.9.3Other descriptive nameBARDOXOLONE METHYL
    D.3.9.4EV Substance CodeSUB33044
    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.IMP: 3
    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 nameBardoxolone methyl 20 mg
    D.3.2Product code RTA 402
    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 INNBardoxolone Methyl
    D.3.9.1CAS number 218600-53-4
    D.3.9.2Current sponsor codeRTA 402
    D.3.9.3Other descriptive nameBARDOXOLONE METHYL
    D.3.9.4EV Substance CodeSUB33044
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 4
    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 nameBardoxolone methyl 15 mg
    D.3.2Product code RTA 402
    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 INNBardoxolone Methyl
    D.3.9.1CAS number 218600-53-4
    D.3.9.2Current sponsor codeRTA 402
    D.3.9.3Other descriptive nameBARDOXOLONE METHYL
    D.3.9.4EV Substance CodeSUB33044
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    D.8 Placebo: 4
    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
    Enfermedad Poliquística Renal Autosómica Dominante
    E.1.1.1Medical condition in easily understood language
    Autosomal dominant polycystic kidney disease
    Enfermedad Poliquística Renal Autosómica Dominante
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036046
    E.1.2Term Polycystic kidney, autosomal dominant
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess the change from baseline in estimated glomerular filtration rate (eGFR) at Week 52 following a 4-week drug treatment withdrawal period.
    - To assess safety and tolerability.
    - Evaluar el cambio de la filtración glomerular estimada (FGe) con respecto al valor inicial en la semana 52 tras un período de suspensión del tratamiento farmacológico de cuatro semanas.
    - Evaluación de la seguridad y tolerabilidad.
    E.2.2Secondary objectives of the trial
    - To assess the change from baseline in eGFR at Week 104 following a 4-week drug treatment withdrawal period.
    - To assess the change from baseline in eGFR after 48 weeks of treatment.
    - To assess the change from baseline in eGFR after 100 weeks of treatment.
    - Evaluar el cambio de la FGe con respecto al valor inicial en la semana 104 tras un período de suspensión del tratamiento farmacológico de cuatro semanas.
    - Evaluar el cambio de la FGe con respecto al valor inicial después de 48 semanas de tratamiento.
    - Evaluar el cambio de la FGe con respecto al valor inicial después de 100 semanas de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients 18 ≤ age ≤ 70 upon study consent;
    2. Diagnosis of ADPKD by modified Pei-Ravine criteria: 1) at least 3 cysts per kidney by sonography or at least 5 cysts by CT or MRI with family history of ADPKD or 2) at least 10cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history;
    3. Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 to ≤ 90 mL/min/1.73 m2 (18 to 55 years) or ≥ 30 to ≤ 44 mL/min/1.73 m2 (56 to 70 years):
    a. Patients with either screening eGFR ≥ 60 to ≤ 90 mL/min/1.73 m2 or age 56 to 70 years, must have evidence of ADPKD progression (i.e., eGFR decline of ≥ 2.0 mL/min/1.73 m2 per year, based on historical eGFR data and medical monitor discretion);
    b. The two eGFR values collected at Screen A and Screen B visits used to determine eligibility must have a percent difference ≤ 25%;
    4. Albumin to creatinine ratio (ACR) ≤ 2500 mg/g at Screen B visit;
    5. Systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 80 mmHg at Screen A visit after a period of rest. Patients receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) must be on a stable dose for at least 6 weeks prior to the Screen A visit;
    6. Adequate bone marrow reserve and organ function at the Screen A visit as follows:
    a. Hematologic: Absolute neutrophil count > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin (Hgb) ≥ 9 g/dL;
    b. Hepatic: Total bilirubin (TBL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN);
    7. Able to swallow capsules;
    8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
    9. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures.
    1. Pacientes varones y mujeres entre 18 y 70 años, tras haber dado el consentimiento de participar en el estudio;
    2. Diagnóstico de PQRAD según los criterios de Pei-Ravine modificados: 1) al menos 3 quistes por riñón determinados por ecografía o al menos 5 quistes determinados por TAC o RM con antecedentes familiares de PQRAD o 2) al menos 10 quistes por riñón determinados por cualquier método radiológico y exclusión de otras enfermedades renales quísticas si no hay antecedentes familiares;
    3. FGe de cribado (promedio de los valores de FGe del cribado A y del cribado B) ≥ 30 a ≤ 90 ml/min/1,73 m2 (de 18 a 55 años) o ≥ 30 a ≤ 44 ml/min/1,73 m2 (56 a 70 años):
    a. Los pacientes con una FGe de cribado ≥ 60 a ≤ 90 ml/min/1,73 m2 o una edad entre 56 y 70 años deben presentar signos de progresión de la PQRAD (es decir, disminución de la FGe ≥ 2,0 ml/min/1,73 m2 por año, según datos de FGe históricos y el criterio del monitor médico);
    b. Los dos valores de FGe recabados en las visitas de cribado A y B y utilizados para determinar la elegibilidad deben presentar una diferencia porcentual ≤ 25 %;
    4. Cociente de albúmina/creatinina (ACR) ≤ 2500 mg/g en la visita de cribado B;
    5.Presión arterial sistólica ≤ 140 mmHg y presión arterial diastólica ≤ 80 mmHg en la visita de cribado A tras un período de reposo. Los pacientes que reciben un inhibidor de la enzima convertidora de angiotensina (ECA) o un bloqueante de los receptores de angiotensina II (BRA) deben estar tomando una dosis estable durante al menos 6 semanas antes de la visita de cribado A;
    6. Reserva de médula ósea conveniente y funcionamiento adecuado de los órganos en la visita de cribado A, como:
    a. Valores hematológicos: cifra absoluta de neutrófilos > 1,5 x 109/l, plaquetas > 100 x 109/l, hemoglobina (Hgb) ≥ 9 g/dl;
    b. Valores hepáticos: bilirrubina total (BT), alanina·transaminasa (ALT) y aspartato·transaminasa (AST) ≤ límite superior de la normalidad (LSN);
    7. Paciente capaz de tragar cápsulas;
    8. Paciente dispuesto y en condiciones de cumplir las visitas programadas, el plan terapéutico, las pruebas de laboratorio y otros procedimientos del estudio;
    9. Existencia de un documento de consentimiento informado firmado personalmente y fechado, que indique que el paciente ha sido informado sobre todos los aspectos pertinentes del estudio, antes de iniciar cualquier procedimiento exigido por el protocolo.
    E.4Principal exclusion criteria
    1. Prior exposure to bardoxolone methyl;
    2. Concomitant use of tolvaptan is excluded. Patients previously treated with tolvaptan must have discontinued drug for at least 3 months prior to Screen A visit and had no history of elevations of ALT or AST > ULN while they were receiving tolvaptan. Initiation of concomitant tolvaptan use during the study is not permitted;
    3. History of administration of polycystic kidney disease-modifying agents (somatostatin analogues) within 3 months prior to the Screen A visit.
    4. B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit;
    5. Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit;
    6. Serum albumin < 3 g/dL at Screen A visit;
    7. History of intracranial aneurysms;
    8. Kidney or any other solid organ transplant recipient or a planned transplant during the study;
    9. Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening;
    10. History of clinically significant left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:
    a. Clinically significant congenital or acquired valvular disease;
    b. Left ventricular ejection fraction < 40% (based on echocardiogram performed at Screen A visit or within 6 months prior to Day 1);
    c. Pericardial constriction (based on echocardiogram performed at Screen A visit or within 6 months prior to Day 1);
    d. Restrictive or congestive cardiomyopathy (based on echocardiogram performed at Screen A visit or within 6 months prior to Day 1);
    e. Symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or angina);
    f. History of hospitalization for heart failure;
    g. Cardiac insufficiency, defined as New York Heart Association Class III or IV;
    h. History of untreated atrial fibrillation;
    i. History of unstable arrhythmias;
    11. Systolic BP < 90 mm Hg at Screen A visit after a period of rest;
    12. BMI < 18.5 kg/m2 at the Screen A visit;
    13. History of malignancy within 5 years prior to Screen A visit, with the exception of localized skin or cervical carcinomas;
    14. Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study;
    15. Untreated or uncontrolled active bacterial, fungal, or viral infection;
    16. Participation in other interventional clinical studies within 30 days prior to Day 1;
    17. Unwilling to practice acceptable methods of birth control (both males who have partners of child-bearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested;
    18. Women who are pregnant or breastfeeding;
    19. Known hypersensitivity to any component of the study drug;
    20. Any abnormal laboratory level that, in the opinion of the investigator, would put the patient at risk by trial enrollment;
    21. Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
    1. Exposición previa a bardoxolona metilo;
    2. El uso concomitante de tolvaptan está excluido. Los pacientes previamente tratados con tolvaptán deben haber dejado de tomar el medicamento durante al menos 3 meses antes de la visita de cribado A y no haber presentado elevaciones de ALT o AST > LSN mientras recibían tolvaptán. Durante el estudio no se permite iniciar un tratamiento concomitante con tolvapán;
    3. Antecedentes de administración de fármacos modificadores de la poliquistosis renal (análogos de la somatostatina) los 3 meses anteriores a la visita de cribado A.
    4. Nivel de péptido natriurético tipo B (BNP) > 200 pg/m en la visita de cribado A;
    5. Diabetes no controlada (HbA1c > 11,0 %) en la visita de cribado A;
    6. Albúmina sérica < 3 g/dl en la visita de cribado A;
    7. Anamnesis de aneurismas intracraneales;
    8. Receptor de un riñón o de otro órgano sólido o trasplante previsto durante el estudio;
    9. Diálisis de corta duración o lesión renal aguda las 12 semanas anteriores a la visita de cribado A o durante el cribado;
    10. Anamnesis de cardiopatía del lado izquierdo clínicamente significativa o cardiopatía clínicamente significativa, p. ej.:
    a. Valvulopatía congénita o adquirida clínicamente significativa;
    b.Fracción de eyección ventricular izquierda < 40 % (según un ecocardiograma realizado en la visita de cribado A o en los 6 meses anteriores al día 1);
    c. Constricción pericárdica (según un ecocardiograma realizado en la visita de cribado A o en los 6 meses anteriores al día 1);
    d. Miocardiopatía restrictiva o congestiva (según un ecocardiograma realizado en la visita de cribado A o en los 6 meses anteriores al día 1);
    e. Coronariopatía sintomática (previa a infarto de miocardio, intervención coronaria percutánea, cirugía de injerto de revascularización coronaria o angina de pecho);
    f. Antecedentes de hospitalización por insuficiencia cardíaca;
    g. Insuficiencia cardíaca, definida como de clase III o IV según la New York Heart Association;
    h. Antecedentes de fibrilación auricular no tratada;
    i. Antecedentes de arritmias inestables;
    11. PA sistólica < 90 mm Hg en la visita de cribado A tras un período de reposo;
    12. IMC < 18,5 kg/m2 en la visita de cribado A;
    13. Antecedentes de neoplasia maligna en los 5 años anteriores a la visita de cribado A, a excepción de carcinomas cutáneos o cervicales localizados;
    14. Inmunosupresión sistémica acumulativa durante más de 2 semanas, en las 12 semanas anteriores a la aleatorización o necesidad anticipada de inmunosupresión durante el estudio;
    15. Infección bacteriana, fúngica o viral activa no tratada o no controlada;
    16. Participación en otros estudios clínicos intervencionistas en los 30 días anteriores al día 1;
    17. Pacientes no dispuestos a practicar métodos aceptables de contracepción (hombres con parejas que pueden quedarse embarazadas y mujeres con posibilidad de quedar embarazadas) durante el cribado, mientras toman el fármaco del estudio, y durante al menos 30 días después tomar la última dosis del fármaco del estudio;
    18. Mujeres embarazadas o que dan el pecho;
    19. Hipersensibilidad conocida a algún componente del fármaco del estudio;
    20. Cualquier resultado de laboratorio anormal que, en opinión del investigador, pondría en riesgo al paciente al inscribirse en el ensayo;
    21. El paciente es, en opinión del investigador, incapaz de cumplir los requisitos del protocolo del estudio o es inadecuado para el estudio por cualquier razón.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    Change from baseline in eGFR at Week 52 (following a 4-week drug treatment withdrawal period).

    Safety and Tolerability:
    Frequency, intensity, and relationship to study drug of AEs and SAEs, and change from baseline in the following assessments: vital sign measurements, 12-lead ECGs, clinical laboratory measurements, and weight.
    Eficacia:
    Cambio con respecto al valor inicial de la FGe en la semana 52 (tras un periodo de suspensión del tratamiento farmacológico de 4 semanas).

    Seguridad y Tolerabilidad:
    Frecuencia, intensidad y relación con el fármaco del estudio de los AA y AAG, y el cambio con respecto del momento inicial en las siguientes evaluaciones: mediciones de signos vitales, 12-lead-ECGs, mediciones clínicas de laboratorio y peso.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint will be analyzed after all patients have completed their Week 52 visit.

    The primary safety endpoint will be assessed throughout the clinical trial.
    El criterio de valoración principal de la eficacia se analizará cuando todos los pacientes hayan completado su visita de la semana 52.

    El criterio de valoración principal de seguridad se evaluará a lo largo del ensayo clínico.
    E.5.2Secondary end point(s)
    - Change from baseline in eGFR at Week 104 (Following a 4-week drug treatment withdrawal period).
    - Change from baseline in eGFR at Week 48 .
    - Change from baseline in eGFR at Week 100.
    - Cambio de la FGe con respecto al valor inicial en la semana 104 (tras un periodo de suspensión del tratamiento farmacológico de cuatro semanas).
    - Cambio de FGe con respecto al valor inicial en la semana 48
    - Cambio de la FGe con respecto al valor inicial en la semana 100
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be scheduled to be assessed during treatment at Weeks 1, 2, 4, 6, 8, 12, 24, 36, 48, 52(A), 52(B), 64, 76, 88, 100, 104(A) and 104(B).
    Los pacientes serán citados para ser evaluados durante el tratamiento en las semanas 1, 2, 4, 6, 8, 12, 24, 36, 48, 52(A), 52(B), 64, 76, 88, 100, 104(A) y 104(B)
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Belgium
    Czech Republic
    France
    Germany
    Italy
    Spain
    United Kingdom
    United States
    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
    Ultima visita último sujeto
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 300
    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)
    After completion of the study subjects will not receive any further study-specific treatment. They will be provided with standard medical care treatment.
    Una vez finalizado el estudio, los sujetos no recibirán ningún tratamiento adicional específico del estudio. Se les proporcionará tratamiento médico estandar.
    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 Decision2019-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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