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    Summary
    EudraCT Number:2014-000770-19
    Sponsor's Protocol Code Number:D5740C00001
    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:2014-11-25
    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 number2014-000770-19
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating
    the Safety and Efficacy of Roxadustat for the Treatment of Anemia in
    Chronic Kidney Disease Patients not on Dialysis
    Ensayo fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo, para evaluar la seguridad y eficacia de roxadustat para el tratamiento de la anemia en pacientes con insuficiencia renal crónica que no están en diálisis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy study of roxadustat to treat anemia in patients with chronic kidney disease (CKD), not on dialysis.
    Ensayo de seguridad y eficacia de roxadustat para el tratamiento de la anemia en pacientes con insuficiencia renal crónica (ICR) que no están en diálisis.
    A.3.2Name or abbreviated title of the trial where available
    OLYMPUS
    OLYMPUS
    A.4.1Sponsor's protocol code numberD5740C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02174627
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1154-2636
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de investigación clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/Serrano Galvache, 56; Parque Norte, Ed. Roble
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number34900200444
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.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 nameroxudastat
    D.3.2Product code AZD9941
    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 INNRoxadustat
    D.3.9.1CAS number 808118-40-3
    D.3.9.2Current sponsor codeAZD9941
    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: 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 nameroxadustat
    D.3.2Product code AZD9941
    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 INNRoxadustat
    D.3.9.1CAS number 808118-40-3
    D.3.9.2Current sponsor codeAZD9941
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 nameroxadustat
    D.3.2Product code AZD9941
    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 INNRoxadustat
    D.3.9.1CAS number 808118-40-3
    D.3.9.2Current sponsor codeAZD9941
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Anemia in chronic kidney disease patients without dialysis.
    Anemia en pacientes con insuficiencia renal crónica sin diálisis.
    E.1.1.1Medical condition in easily understood language
    Anemia in patients with severe renal disease without dialysis.
    Anemia en pacientes con insufciencia renal grave sin diálisis.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the cardiovascular (CV) safety of roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD) not on dialysis therapy.
    Evaluar la seguridad cardiovascular (CV) de roxadustat para el tratamiento de la anemia en pacientes con IRC que no están recibiendo diálisis.
    E.2.2Secondary objectives of the trial
    Evaluate the efficacy of roxadustat.

    Evaluate the CV safety of roxadustat for the composite endpoint of all cause mortality, non-fatal Myocardial Infarction (MI), non-fatal stroke, heart failure requiring hospitalization and unstable angina leading to hospitalization

    Evaluate the CV safety of roxadustat for the composite safety endpoint (CSE) of all cause mortality, non-fatal MI, non-fatal stroke, heart failure requiring hospitalization, unstable angina leading to hospitalization, deep vein thrombosis, pulmonary embolism, vascular access thrombosis or hypertensive emergency

    Evaluate the need for rescue therapy

    CKD progression

    Evaluate the effect of roxadustat on anemia symptoms and health-related quality of life (HRQoL)

    Evaluate the effect of roxadustat on self-reported health status.

    To evaluate the safety and tolerability of roxadustat
    Evaluar la eficacia de roxadustat.

    Evaluar la seguridad CV de roxadustat en el endpoint compuesto de mortalidad por cualquier causa, IM no mortal, ictus no mortal, insuficiencia cardíaca que precisa hospitalización y angina inestable que conduce a hospitalización

    Evaluar la seguridad CV de roxadustat en el endpoint de seguridad compuesto (CSE), por mortalidad por cualquier causa, IM no mortal, ictus no mortal, insuficiencia cardíaca que precisa hospitalización, angina inestable que conduce a hospitalización, trombosis venosa profunda, embolismo pulmonar, trombosis del acceso vascular o urgencia hipertensiva

    Evaluar la necesidad de tratamiento de rescate

    Progresión de IRC

    Evaluar el efecto de roxadustat sobre los síntomas de anemia y la calidad de vida relacionada con la salud (CdVRS)

    Evaluar el efecto de roxadustat sobre el estado de salud descrito por el paciente

    Evaluar la seguridad y tolerabilidad de roxadustat
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age > or = 18 years. - A glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, corresponding to stage 3, 4 or 5 chronic kidney disease (CKD) according to the Kidney Disease Outcomes Quality Initiative, not receiving dialysis. - Mean of 2 most recent central laboratory hemoglobin (Hb) values during the screening period, obtained at least 7 days apart, must be <10.0 g/dL.- Ferritin > or = 50 ng/mL at randomization. - Transferrin saturation > o = 15% at randomization. - Serum folate level > or = lower limit of normal (LLN) at randomization. - Serum vitamin B12 level > o = LLN at randomization. - Alanine aminotransferase and aspartate aminotransferase < or = 3 x upper limit of normal (ULN) and total bilirubin < or = 1.5 x ULN at randomization. - Body weight 45 to 160 kg.
    -Edad > o = 18 años.- TFGe < 60 ml/min/1,73 m2 correspondiente a IRC estadio 3, 4 ó 5 de acuerdo con las guías clínicas para enfermedad renal crónica (KDOQI) que no están recibiendo diálisis.- La media de los 2 valores de Hb más recientes obtenidos en el laboratorio central durante el periodo de selección, obtenidos con una separación de al menos 7 días, debe ser <10 g/dl.- Ferritina > o = 50 ng/ml en la aleatorización.- TSAT > o = 15% en el momento de la aleatorización.- Nivel de folato sérico > o = límite inferior de la normalidad (LIN) en el momento de la aleatorización.- Nivel sérico de vitamina B12 > o = LIN en el momento de la aleatorización.- Alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) > o = 3 x límite superior de la normalidad (LSN) y bilirrubina total (BiliT) < o = 1,5 x LSN en el momento de la aleatorización.- Peso corporal de 45 a 160 kg.
    E.4Principal exclusion criteria
    -Any erythropoietin analogue treatment within 6 weeks of randomization.- New York Heart Association Class III or IV congestive heart failure at enrollment- Myocardial infarction, acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.- History of chronic liver disease (e.g., chronic infectious hepatitis, chronic autoimmune liver disease, cirrhosis or fibrosis of the liver).- Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD.- Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis).- Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category IIF, III or IV) of renal cell carcinoma on renal ultrasound (or other imaging procedure e.g. computerized tomography scan or magnetic resonance imaging conducted at screening or within 12 weeks prior to randomization.- Systolic blood pressure (BP) > or = 160 mmHg or diastolic BP > or = 95 mmHg, within 2 weeks prior to randomization. Patients may be rescreened once BP controlled.- History of prostate cancer, breast cancer or any other malignancy, except the following: cancers determined to be cured or in remission for > or = 5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.- Positive for any of the following: human immunodeficiency virus, hepatitis B surface antigen or anti-hepatitis C virus antibody.- Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be the principal cause of anemia.- Known hemosiderosis, hemochromatosis or hypercoagulable condition.- Any prior organ transplant or a scheduled organ transplantation date.- Any red blood cell transfusion during the screening period.- Any current condition leading to active significant blood loss.- Any treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor.- Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within at least 1 month of the first administration of investigation product in this study. (Note: patients consented and screened, but not randomized in this study or a previous study are not excluded).- History of alcohol or drug abuse within 2 years prior to randomization. - Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence. - Pregnant or breastfeeding females.- Known allergy to the investigational product or any of its ingredients.- Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound safety or efficacy assessment or may interfere with study participation.
    -Cualquier tratamiento con análogo de eritropoyetina dentro de las 6 semanas previas a la aleatorización.- Insuficiencia cardíaca congestiva de clase III o IV de la New York Heart Association en el momento del reclutamiento.-Infarto de miocardio (IM), síndrome coronario agudo, ictus, crisis epiléptica o un acontecimiento trombótico/tromboembólico (p. ej., trombosis venosa profunda o embolismo pulmonar) dentro de las 12 semanas previas a la aleatorización.-Antecedentes de enfermedad hepática crónica (p. ej., hepatitis infecciosa crónica, enfermedad hepática crónica autoinmune, cirrosis o fibrosis del hígado).- Enfermedad hematológica hereditaria conocida, tal como talasemia, anemia falciforme o antecedentes de aplasia pura de los glóbulos rojos u otras causas conocidas de anemia distintas de la IRC.- Oclusión venosa retiniana conocida y no tratada y retinopatía proliferativa diabética no tratada (riesgo de trombosis venosa retiniana).- Diagnóstico o sospecha (p. ej., quiste renal complejo de categoría IIF, III o IV de Bosniak) de carcinoma de células renales en ecografía renal (u otros procedimientos de imagen (p. ej. TAC o RM) realizados en la selección o dentro de las 12 semanas previas a la aleatorización.- PA sistólica > o = 160 mmHg o PA diastólica > o = 95 mmHg dentro del plazo de 2 semanas antes de la aleatorización. Los pacientes pueden volver a someterse a selección una vez que esté controlada la PA.- Antecedentes de cáncer de próstata, cáncer de mama o cualquier otro tumor maligno, excepto los siguientes: cánceres que se ha determinado que están curados o en remisión durante > o = 5 años, cánceres de piel basocelulares o de células escamosas resecados de forma curativa, cáncer cervical in situ o pólipos colónicos resecados.- Positividad para cualquiera de lo siguiente: virus de la inmunodeficiencia humana (VIH); antígeno de superficie de la hepatitis B (HbsAg) o anticuerpo anti-virus de la hepatitis C (Ac anti-VHC) Enfermedades inflamatorias crónicas tales como artritis reumatoide, LES, espondilitis anquilosante, artritis psoriásica o enfermedad inflamatoria intestinal determinadas como la causa principal de la anemia.- Diagnóstico conocido de hemosiderosis, hemocromatosis o un problema de hipercoagulabilidad.- Cualquier trasplante de órganos previo o fecha programada de un trasplante de órganos.- Cualquier transfusión de glóbulos rojos (GR) durante el periodo de selección.- Cualquier problema actual que conduzca a una pérdida significativa de sangre.- Cualquier tratamiento con roxadustat o un inhibidor de la prolil hidroxilasa del factor inducible por hipoxia (HIF-PHI).- Haber recibido otra entidad química nueva (definida como un compuesto que no haya sido aprobado para comercialización) o haber participado en cualquier otro ensayo clínico que incluyera un tratamiento farmacológico dentro del plazo de al menos 1 mes antes de la primera administración del PEI en este ensayo. (Nota: no se excluye a los pacientes que hayan dado su consentimiento y hayan sido sometidos a la selección pero no aleatorizados en este ensayo o en un ensayo previo).- Antecedentes de alcoholismo o abuso de drogas en los 2 años previos a la aleatorización.- Mujeres potencialmente fértiles, a menos que estén utilizando métodos anticonceptivos como se detalla en el protocolo o bien abstinencia sexual (véase la Sección 3.8).- Mujeres embarazadas o en la lactancia.- Alergia conocida al producto en investigación o a cualquiera de sus ingredientes.- Cualquier problema médico, incluidas infecciones activas, clínicamente significativas, que, en opinión del investigador o el promotor puedan plantear un riesgo de seguridad para un paciente de este ensayo, que puedan causar confusión en la evaluación de seguridad o eficacia o que puedan interferir con la participación en el ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    1. Major adverse cardiovascular (CV) events (MACE): Time to first occurrence of all cause mortality, non-fatal myocardial infarction or non-fatal stroke.
    Acontecimientos adversos CV importantes (MACE): tiempo hasta la primera aparición de mortalidad por cualquier causa, infarto de miocardio (IM) no mortal o ictus no mortal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From randomization (week 0) to end of study (event-driven, anticipate 1-2 years).
    1. Desde la aleatorización (semana 0) hasta el final del ensayo (conducido por acontecimientos, estimado 1-2 años).
    E.5.2Secondary end point(s)
    1. Mean change in hemoglobin (Hb) from baseline to the end of treatment visit (event-driven, anticipate 1-2 years).
    2. Proportion of total time of Hb measurements within the interval of 11±1 g/dL from week 28 until end of treatment visit (event-driven, anticipate 1-2 years).
    3. MACE+: Time to first occurrence of all cause mortality, non-fatal myocardial infarction (MI) or non-fatal stroke, heart failure requiring hospitalization or unstable angina leading to hospitalization.
    4. Time to first occurrence of all cause mortality, non-fatal MI, non-fatal stroke, heart failure requiring hospitalization, unstable angina leading to hospitalization, deep vein thrombosis, pulmonary embolism, vascular access thrombosis or hypertensive emergency.
    5. Time-to-first instance of receiving intravenous (IV) iron, red blood cell (RBC) transfusions or erythropoietin analogue as rescue therapy.
    6.Change in estimated glomerular filtration rate (eGFR) from baseline to the end of treatment visit(event-driven, anticipate 1-2 years).
    7. Changes in anemia symptoms and four disease-specific Health Related Quality of Life (HRQoL) domains as measured by the Funtional Assessment of Cancer Therapy-Anemia (FACT-An). Measured at visit randomization (week 0), week 12, 28 and 52.
    8.Changes in generic HRQoL as measured by the Short Form 36 (SF-36) (vers 2, standard). Measured at visit randomization (week 0), week 12, 28 and 52.
    9. Changes in self-reported health status as measured by the EuroQol Health Utility Index (EQ-5D-5L) and Patients? Global Impression of Change (PGIC) measured at baseline, week 12, 28 and 52.
    10. Adverse events (AEs), serious adverse events (SAEs) and changes in vital signs, electrocardiogram (ECG) and laboratory values. Measured from the first screening visit to the end of the study (event-driven, anticipated duration 1-2 years).
    1.Variación media en la hemoglobina (Hb) entre el momento basal y el final del periodo de tratamiento.
    2.Proporción del tiempo total de mediciones de Hb dentro del intervalo de 11±1 g/dl desde la semana 28 hasta la visita de final de tratamiento.
    3.MACE+: Tiempo hasta la primera aparición de mortalidad por cualquier causa, IM no mortal o ictus no mortal, insuficiencia cardíaca que precisa hospitalización o angina inestable que conduce a hospitalización.
    4.Tiempo hasta la primera aparición de mortalidad por cualquier causa, IM no mortal, ictus no mortal, insuficiencia cardíaca que precisa hospitalización, angina inestable que conduce a hospitalización, trombosis venosa profunda, embolismo pulmonar, trombosis del acceso vascular o urgencia hipertensiva.
    5.Tiempo hasta el primer momento en que se reciba hierro intravenoso (i.v), transfusión de glóbulos rojos (GR) o un análogo de eritropoyetina como tratamiento de rescate.
    6.Cambio en la tasa de filtración glomerular estimada (TFGe) desde el momento basal hasta el final del período de tratamiento.
    7.Cambios en los síntomas de anemia y cuatro parámetros específicos de CdVRS medidos mediante la escala FACT-An
    8.Cambios en la CdVRS genérica medida mediante el SF-36 (versión 2, estándar).
    9.Cambios en el estado de salud descrito por el paciente, medido a través del EQ-5D-5L y PGIC.
    10.Acontecimientos adversos (AA), acontecimientos adversos graves (AAG) y cambios en las constantes vitales, el electrocardiograma (ECG) y los valores de laboratorio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From baseline to end of study (event-driven, anticipate 1-2 years).
    2. From week 28 until end of study (event-driven, anticipate 1-2 years).
    3. From randomization (week 0) to end of study (event-driven, anticipate 1-2 years).
    4.From randomization (week 0) to end of study (event-driven, anticipate 1-2 years).
    5. From randomization (week 0) to end of study (event-driven, anticipate 1-2 years).
    6. From baseline to end of study (event-driven, anticipate 1-2 years).
    7. Measured at visit randomization (week 0), week 12, 28 and 52.
    8. Measured at visit randomization (week 0), week 12, 28 and 52.
    9. At baseline, week 12, 28 and week 52
    10.From the first screening visit to the end of the study (event-driven, anticipated duration 1-2 years).
    1.Desde el momento basal al final del ensayo (conducido por acontec.,estim 1-2 años).2.Dsd la semana 28 hasta la visita final ensayo (conducido por acontec.,estim.1-2 años).3.Dsd la aleatorización (semana 0) al final ensayo (conducido por acontec.,estim.1-2 años).4.Dsd e la aleatorización (semana 0) al final ensayo (conducido por acontec.,estim.1-2 años).5 Dsd la aleatorización (semana 0) al final ensayo (conducido por acontec.,estim.1-2 años).6.Dsd el momento basal hasta final del ensayo (conducido por acontec.,estim.1-2 años).7.Medido en visita de aleatorización (semana 0), semana 12,28,52.8.Medido en visita de aleatorización (semana 0), semana 12,28,52.9.En el momento basal, semana 12,28,52.10. Dsd la primera visita de selección al final ensayo (conducido por acontec.,estim.1-2 años).
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Evaluate self-reported health status.
    Evaluate the need for rescue therapy.
    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 Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA81
    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
    Argentina
    Brazil
    Bulgaria
    Canada
    Czech Republic
    Germany
    Hungary
    India
    Italy
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Slovakia
    Spain
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    United States
    Vietnam
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days15
    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: 1300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1300
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 460
    F.4.2.2In the whole clinical trial 2600
    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 Decision2015-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-04
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