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    Summary
    EudraCT Number:2014-000780-40
    Sponsor's Protocol Code Number:D5740C00002
    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:2014-11-21
    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 number2014-000780-40
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of the Safety and Efficacy of Roxadustat in the Treatment of Anemia in Dialysis Patients
    Ensayo fase 3, multicéntrico, aleatorizado, abierto, con control activo, de la seguridad y eficacia de roxadustat en el tratamiento de la anemia en pacientes 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, on dialysis
    Ensayo de seguridad y eficacia de roxadustat en el tratamiento de la anemia en pacientes con insuficiencia renal crónica en diálisis
    A.3.2Name or abbreviated title of the trial where available
    ROCKIES
    ROCKIES
    A.4.1Sponsor's protocol code numberD5740C00002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02174731
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1154-2734
    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 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 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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Eprex
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag GmbH
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEprex
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEpoetin alfa
    D.3.9.1CAS number 113427-24-0
    D.3.9.3Other descriptive nameepoetin alfa
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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: 5
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Eprex
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag GmbH
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEprex
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepoetin alfa
    D.3.9.1CAS number 113427-24-0
    D.3.9.3Other descriptive nameepoetin alfa
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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: 6
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Eprex
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag GmbH
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEprex
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepoetin alfa
    D.3.9.1CAS number 113427-24-0
    D.3.9.3Other descriptive nameepoetin alfa
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    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: 7
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Eprex
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag GmbH
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEprex
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepoetin alfa
    D.3.9.1CAS number 113427-24-0
    D.3.9.3Other descriptive nameepoetin alfa
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anemia in chronic kidney disease patients with dialysis
    Anemia en pacientes con insuficiencia renal crónica con diálisis.
    E.1.1.1Medical condition in easily understood language
    Anemia in patients with severe renal disease with dialysis
    Anemia en pacientes con enfermedad renal grave con 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 based on comparison with epoetin alfa for the composite endpoint of all cause mortality, non-fatal myocardial infarction and non-fatal stroke
    Evaluar la seguridad cardiovascular (CV) de roxadustat de acuerdo con la comparación con epoetina alfa en el endpoint compuesto de mortalidad por cualquier causa, infarto de miocardio (IM) no mortal e ictus no mortal
    E.2.2Secondary objectives of the trial
    Evaluate the efficacy of roxadustat as compared to epoetin alfa

    Evaluate the CV safety of roxadustat based on comparison with epoetin alfa for the composite endpoint of all cause mortality, non-fatal myocardial infarction, non-fatal stroke, heart failure requiring hospitalization and unstable angina leading to hospitalization

    Evaluate the CV safety of roxadustat based on comparison with epoetin alfa for the composite safety endpoint (CSE) of all cause mortality, non-fatal myocardial infarction, non-fatal stroke, heart failure leading to hospitalization, unstable angina requiring hospitalization, vascular access thrombosis, deep vein thrombosis, pulmonary embolism or hypertensive emergency.

    Evaluate the need for rescue therapy in patients treated with roxadustat as compared to epoetin alfa

    Evaluate self-reported health status in patients treated with roxadustat as compared to epoetin alfa

    To assess the safety and tolerability of roxadustat as compared to epoetin alfa
    Evaluar eficacia de roxadustat en comparación con epoetina alfa
    Evaluar seguridad CV de roxadustat de acuerdo con la comparación con epoetina alfa en endpoint compuesto de mortalidad por cualquier causa, IM no mortal, ictus no mortal, insuf. cardíaca con hospitalización y angina inestable que lleva a hospitalización
    Evaluar seguridad CV de roxadustat de acuerdo con comparación con epoetina alfa en endpoint de seguridad compuesto, formado por mortalidad por cualquier causa, IM no mortal, ictus no mortal, insuf. cardíaca con hospitalización, angina inestable que lleva a hospitalización, trombosis en el acceso vascular, trombosis venosa profunda, embolismo pulmonar o urgencia hipertensiva
    Evaluar necesidad de tratamiento de rescate en pacientes tratados con roxadustat en comparación con epoetina alfa
    Evaluar estado salud autocomunicado en pacientes tratados con roxadustat en comparación con epoetina alfa
    Evaluar seguridad y tolerabilidad de roxadustat en comparación con epoetina alfa
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > or = 18 years
    - Receiving or initiating hemodialysis or peritoneal dialysis for treatment of native kidney end-stage renal disease at least 30 days prior to visit 1.
    - Two central laboratory Hb values during the screening period, obtained at least 7 days apart, must be <12 g/dL in patients currently treated with an erythropoietin analouge or <10 g/dL in patients not currently treated with an erythropoietin analouge. Patients are considered not currently treated if they have not received either Mircera® for at least 8 weeks or any other erythropoietin analouge for at least 4 weeks prior to visit 1.
    - Ferritin > or = 100 ng/mL at randomization.
    - Transferrin saturation (TSAT) > or = 20% at randomization.
    - Serum folate level > or = lower limit of normal (LLN) at randomization.
    - Serum vitamin B12 level > or = LLN at randomization.
    - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < or = 3x 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 en la visita 1 de selección.
    - Estar recibiendo o ir a iniciar hemodiálisis o diálisis peritoneal para el tratamiento de enfermedad renal terminal (ERT) natural al menos 30 días antes de la visita 1.
    - Dos valores de Hb en el laboratorio central durante el periodo de selección, obtenidos con una separación de al menos 7 días, debe ser <12 g/dl en los pacientes tratados actualmente con un análogo de eritropoyetina o <10 g/dl en los pacientes que no reciben actualmente un análogo de eritropoyetina. Se considerará que los pacientes no están siendo tratados actualmente si no han recibido Mircera® durante al menos 8 semanas ni ningún otro análogo de eritropoyetina durante al menos 4 semanas antes de la visita 1.
    - Ferritina > o =100 ng/ml en la aleatorización.
    - TSAT > o =20% 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) o aspartato aminotransferasa (AST) < o = 3x límite superior de la normalidad (LSN) y bilirrubina total < o = 1,5 x LSN en el momento de la aleatorización.
    - Peso corporal de 45 a 160 kg.
    E.4Principal exclusion criteria
    - New York Heart Association Class III or intravenous (IV) congestive heart failure at enrollment - Myocardial infarction, acute coronary syndrome, stroke, seizure or a thrombotic 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 chronic kidney disease (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 (CT) scan or magnetic resonance imaging (MRI)) conducted at screening or within 12 weeks prior to randomization. - Uncontrolled hypertension at the time of randomization, (defined as systolic BP > or =180 mmHg or diastolic BP > or =100 mmHg on repeated measurement post-dialysis in hemodialysis patients or at any time in peritoneal dialysis patients), contraindication to epoetin alfa treatment (e.g., pure red cell aplasia, hypersensitivity or know inability to tolerate epoetin alfa). - 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 (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody. - Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be principal cause of anemia. - Known hemosiderosis, hemochromatosis or hypercoagulable condition. - Any prior organ transplant with the exception of a renal transplant that was subsequently removed (?explanted?) or scheduled organ transplantation date. - Any red blood cell (RBC) transfusion during the screening period. - Any current condition leading to active significant blood loss. - Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). - 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.
    - Insuficiencia cardíaca congestiva de clase III o IV de la New York Heart Association en el momento del reclutamiento.
    - Infarto de miocardio, 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 hepatopatía crónica (p. ej., hepatitis infecciosa crónica, enfermedad hepática crónica autoinmunitaria, 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.
    Hipertensión no controlada en el momento de la aleatorización (definida como PA sistólica > o =180 mmHg o PA diastólica > o =100 mmHg en una medición repetida después de la diálisis en pacientes en hemodiálisis, o en cualquier momento en pacientes en diálisis peritoneal) contraindicación para el tratamiento con epoetina alfa (p. ej., aplasia pura de los glóbulos rojos, hipersensibilidad o incapacidad conocida para tolerar la epoetina alfa).
    - 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 espinocelulares 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.
    - Enfermedades inflamatorias crónicas tales como artritis reumatoide, LES, espondilitis anquilosante, artritis psoriásica o enfermedad inflamatoria intestinal consideradas como la principal causa de la anemia.
    - Diagnóstico conocido de hemosiderosis, hemocromatosis o un problema de hipercoagulabilidad.
    - Cualquier trasplante de órganos previo, a excepción de un trasplante renal que se haya retirado posteriormente (?explantado?) o fecha programada para 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 previo con roxadustat o un inhibidor de la prolil hidroxilasa del factor inducible por hipoxia (HIF-PHI).
    - 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.
    - Mujeres embarazadas o en la lactancia.
    - Alergia conocida al producto en investigación o a cualquiera de sus ingredientes.
    E.5 End points
    E.5.1Primary end point(s)
    Major adverse cardiovascular (CV) events (MACE): Time to first occurrence of death from any cause, non-fatal myocardial infarction or non-fatal stroke.
    Acontecimientos adversos CV importantes (MACE): tiempo hasta la primera aparición de muerte por cualquier causa, infarto de miocardio (IM) no mortal e ictus no mortal
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization (week 0) to end of study (event-driven, anticipate 1-2 years).
    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 period (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. Major adverse CV events+ (MACE+): Time to first occurrence of death from any cause, non-fatal myocardial infarction (MI), non-fatal stroke, heart failure requiring hospitalization or unstable angina leading to hospitalization.
    4. Time to first occurrence of death from any cause, non-fatal MI, non-fatal stroke, heart failure requiring hospitalization, unstable angina leading to hospitalization, vascular access thrombosis, deep vein thrombosis, pulmonary embolism or hypertensive emergency.
    5. Time to first rescue therapy (composite of erythropoietin analogue therapy [for roxadustat-allocated patients only] or RBC transfusion).
    6.Changes in self-reported health status as measured by the EuroQol Health Utility Index (EQ-5D-5L) during roxadustat or epoetin alfa treatment. Measured at baseline, week 12, 28 and 52.
    7. Adverse events (AEs), serious adverse events (SAEs) 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 (conducido por acontecimientos, estimado 1-2 años).
    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 (conducido por acontecimientos, estimado 1-2 años).
    3. MACE+: Tiempo hasta la primera aparición de mortalidad por cualquier causa, IM no mortal, 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 tratamiento de rescate (compuesto de tratamiento con un análogo de eritropoyetina [sólo para pacientes asignados a roxadustat] o transfusión de GR).
    6. Cambios en el estado de salud autocomunicado medido por el EQ-5D-5L durante el tratamiento con roxadustat o epoetina alfa. Medidos desde el momento basal, semana 12, 28 y 52.
    7. Acontecimientos adversos (AA), acontecimientos adversos graves (AAG) y cambios en las constantes vitales, el electrocardiograma (ECG) y los valores de laboratorio. Medido en visita 1 de selección hasta el final del ensayo (conducido por acontecimientos, duración estimada 1-2 años).
    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. At baseline, week 12, 28 and 52.
    7. From the first screening visit to the end of the study (event-driven, anticipated duration 1-2 years).
    1.Desde el momento basal hasta el final del ensayo (conducido por acontecimientos, estimado 1-2 años).
    2.Desde la semana 28 hasta el final del ensayo (conducido por acontecimientos, estimado 1-2 años).
    3.Desde la aleatorización (semana 0) hasta el final del ensayo (conducido por acontecimientos, estimado 1-2 años).
    4.Desde la aleatorización (semana 0) hasta el final del ensayo (conducido por acontecimientos, estimado 1-2 años).
    5.Desde la aleatorización (semana 0) hasta el final del ensayo (conducido por acontecimientos, estimado 1-2 años).
    6. Desde el momento basal, semana 12, 28 y 52.
    7. Medido en visita 1 de selección hasta el final del ensayo (conducido por acontecimientos, duración estimada 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 in patients treated with roxadustat as compared to EPO
    Evaluar el estado de salud autocomunicado
    Evaluar la necesidad de tratamiento de rescate en pacientes tratados con roxadustat en comparación con EPO
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    Australia
    Brazil
    Bulgaria
    Canada
    Czech Republic
    Hungary
    India
    Mexico
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Slovakia
    Spain
    Sweden
    Thailand
    Ukraine
    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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 700
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 370
    F.4.2.2In the whole clinical trial 1425
    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 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 trial2018-09-26
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