Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   37756   clinical trials with a EudraCT protocol, of which   6186   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-000780-40
    Sponsor's Protocol Code Number:D5740C00002
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-21
    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 ConcernedPoland - Office for Medicinal Products
    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
    Wieloośrodkowe, randomizowane, otwarte, kontrolowane substancją aktywną badanie III fazy oceniające bezpieczeństwo i skuteczność stosowania Roxadustatu w leczeniu niedokrwistości u pacjentów dializowanych
    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





    Badanie oceniające bezpieczeństwo i skuteczność stosowania roxadustatu w leczeniu niedokrwistości u dializowanych pacjentów z przewlekła chorobą nerek.
    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 AB
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike, PO Box 15437
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post code19850-5437
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.centre@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 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: 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 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: 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 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.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
    Niedokrwistość u pacjentów z przewlekła chorobą nerek z dializoterapią
    E.1.1.1Medical condition in easily understood language
    Anemia in patients with severe renal disease with dialysis
    Anemia u pacjentów dializowanych, z ciężką chorobą nerek
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of roxadustat for the treatment of anemia in CKD subjects on dialysis

    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
    Ocena skuteczności roxadustatu w leczeniu anemii u dializowanych chorych z przewlekłą chorobą nerek (CKD).

    Ocena bezpieczeństwa sercowo-naczyniowego (S-N) roxadustatu na podstawie porównania z epoetyną alfa (EPO) pod względem złożonego punktu końcowego obejmującego zgon z dowolnej przyczyny, zawał serca niezakończony zgonem (MI) i udar mózgu niezakończony zgonem)
    E.2.2Secondary objectives of the trial
    Evaluate the efficacy of roxadustat as compared to epoetin alfa

    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

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

    To assess the safety and tolerability of roxadustat as compared to epoetin alfa
    Ocena
    - skuteczności roxadustatu w porównaniu z EPO

    - konieczności stosowania terapii ratunkowej roxadusta w porównaniu z EPO

    -Samoocena stanu zdrowia pacjentów z roxadustatem w porównaniu z EPO

    -bezpieczeństwa S-N roxadustatu - porównanie z EPO pod względem złożonego punktu końcowego: zgon z dowolnej przyczyny, zawał serca niezakończony zgonem, udar mózgu niezakończony zgonem i niestabilną chorobę wieńcowa powodująca hospitalizację

    -bezpieczeństwa S-N roxadustatu - porównanie z EPO pod względem złożonego punktu końcowego bezpieczeństwa (ang. Composite Safety Endpoint - CSE) obejmującego zgon z dowolnej przyczyny, zawał serca niezakończony zgonem, udar mózgu niezakończony zgonem, niewydolność serca wymagającą hospitalizacji, niestabilną chorobę wieńcową powodującą hospitalizację, zakrzepicę w miejscu dostępu naczyniowego, zakrzepicę żył głębokich oraz zatorowość płucną lub nagły wzrost cieśnienia tętniczego

    -bezpieczeństwa i tolerancji roxadustatu w porównaniu z EPO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥18 years
    - Receiving or initiating hemodialysis or peritoneal dialysis for treatment of native kidney end-stage renal disease (ESRD) for a minimum of 2 weeks and a maximum of 4 months prior to randomization. Patients treated with hemodialysis must have access consisting of an arteriovenous fistula, AV graft, or tunneled (permanent) catheter. Patients on peritoneal dialysis must have a functioning peritoneal dialysis catheter in place
    - 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 ≥100 ng/mL at randomization.
    - Transferrin saturation (TSAT) ≥20% at randomization.
    - Serum folate level ≥ lower limit of normal (LLN) at randomization.
    - Serum vitamin B12 level ≥LLN at randomization.
    - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3x upper limit of normal (ULN), and total bilirubin ≤1.5 x ULN at randomization.
    - Body weight 45 to 160 kg.
    -Wiek ≥18 lat
    - Stosowanie lub rozpoczęcie hemodializy lub dializy otrzewnowej w ramach leczenia schyłkowej niewydolności nerek (ESRD) przez minimum 2 tygodnie i maximum 4 miesiące przed randomizacją. Pacjenci poddawania hemodializie muszą posiadać dostęp naczyniowy do hemodializy obejmujący przetokę tętniczo-żylną z własnych naczyń, sztuczną przetokę tętniczo-żylną lub cewnik naczyniowy typu permanentnego. Pacjenci leczeni dializą otrzewnową muszą mieć wszczepiony do jamy otrzewnowej cewnik.
    -Stosowanie lub rozpoczęcie hemodializy lub dializy otrzewnowej w ramach leczenia schyłkowej niewydolności nerek (ESRD) w okresie co najmniej 30 dni przed wizytą 1.
    -Średnia z 2 wyników oznaczenia Hb w laboratorium centralnym w okresie przesiewowym, uzyskanych w odstępie co najmniej 7 dni, musi wynosić <12 g/dl u pacjentów aktualnie leczonych rekombinowaną erytropoetyną lub <10 g/dl u pacjentów, którzy nie otrzymują aktualnie leczenia rekombinowaną erytropoetyną. Pacjenci będą uważani za nieotrzymujących aktualnie leczenia, jeżeli nie otrzymywali preparatu Mircera® przez co najmniej 8 tygodni ani jakiejkolwiek innej rekombinowanej erytropoetyny przez co najmniej 4 tygodnie przed wizytą 1.
    -Ferrytyna ≥100 ng/ml podczas randomizacji
    -TSAT ≥20% podczas randomizacji
    -Stężenie folianów w surowicy ≥ dolnej granicy normy (DGN) przy randomizacji
    -Stężenie witaminy B12 w surowicy ≥DGN przy randomizacji
    -Aktywność aminotransferazy alaninowej (ALT) i aminotransferazy asparaginianowej (AST) ≤3 x górna granica normy (GGN) i stężenie bilirubiny całkowitej (Tbili) ≤1,5 x GGN w chwili randomizacji.
    -Masa ciała od 45 do 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 ≥180 mmHg or diastolic BP ≥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 ≥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.
    -Zastoinowa niewydolność serca kategorii III lub IV według Nowojorskiego Towarzystwa Kardiologicznego (ang. NYHA Class III or IV) w chwili włączenia do badania
    -Zawał mięśnia sercowego, ostry zespół wieńcowy, udar mózgu, napad padaczkowy lub incydent zakrzepowo-zatorowy (np. zakrzepica żył głębokich lub zatorowość płucna) w okresie 12 tygodni przed randomizacją
    -Przewlekła choroba wątroby (np. przewlekłe zapalenie wątroby, przewlekła autoimmunologiczna choroba wątroby, marskość wątroby lub zwłóknienie wątroby).
    Stwierdzona dziedziczna choroba hematologiczna, taka jak talasemia, niedokrwistość sierpowatokrwinkowa lub czysta aplazja czerwonokrwinkowa w wywiadzie, bądź inne znane przyczyny niedokrwistości, inne niż PChN
    Stwierdzona i nieleczona niedrożność żyły siatkówki lub stwierdzona i nieleczona proliferacyjna retinopatia cukrzycowa (ryzyko zakrzepu żyły siatkówki).
    -Rozpoznanie lub podejrzenie raka nerkowokomórkowego (np. złożona torbiel nerki kategorii II, III lub IV wg Bosniaka) w badaniu ultrasonograficznym (lub innym badaniu obrazowym, np. badaniu TK lub MRI), wykonanym podczas oceny przesiewowej lub w okresie 12 tygodni przed randomizacją.
    -Niewyrównane nadciśnienie tętnicze w chwili randomizacji (definiowane jako ciśnienie tętnicze skurczowe ≥180 mmHg lub rozkurczowe ≥100 mmHg przy powtórnym pomiarze u pacjentów hemodializowanych po dializie lub w dowolnym momencie u pacjentów z dializą otrzewnową), przeciwwskazanie do leczenia epoetyną alfa (np. aplazja czerwonokrwinkowa, nadwrażliwość lub w wywiadzie nietolerancja epoetyny alfa).
    -Rak gruczołu krokowego, rak piersi lub jakikolwiek inny nowotwór złośliwy w wywiadzie, z wyjątkiem: nowotworów uznanych za wyleczone lub pozostające w remisji od ≥5 lat, poddanego doszczętnej resekcji raka podstawnokomórkowego lub kolczystokomórkowego skóry, raka szyjki macicy in situ lub polipów okrężnicy po resekcji
    -Dodatni wynik któregokolwiek z następujących badań na obecność: zakażenia ludzkim wirusem upośledzenia odporności (HIV), antygenu powierzchniowego wirusa zapalenia wątroby typu B (HBsAg) lub przeciwciała przeciwko wirusowi zapalenia wątroby typu C (anty-HCV Ab).
    -Przewlekłe choroby zapalne, takie jak reumatoidalne zapalenie stawów, SLE, zesztywniające zapalenie stawów kręgosłupa, łuszczycowe zapalenie stawów lub choroba zapalna jelit, która może być uznana za pierwotną przyczynę niedokrwistości
    -Stwierdzona hemosyderoza, hemochromatoza lub stan nadkrzepliwości.
    -Jakiekolwiek wcześniejsze przeszczepienie narządu, z wyjątkiem przeszczepu nerki, którą następnie usunięto, lub zaplanowane przeszczepienie narządu
    -Jakiekolwiek przetoczenie krwinek czerwonych (RBC) w okresie przesiewowym
    -Jakakolwiek aktualnie występująca choroba prowadząca do aktywnej istotnej utraty krwi
    -Jakiekolwiek leczenie roxadustatem lub inhibitorem hydroksylazy prolilowej czynnika indukowanego niedotlenieniem (HIF-PHI).
    -Nadużywanie alkoholu lub narkotyków w wywiadzie w okresie 2 lat przed randomizacją
    -Kobiety w wieku rozrodczym, chyba że stosują antykoncepcję określoną w protokole lub przestrzegają abstynencji seksualnej
    -Kobiety w ciąży lub karmiące piersią
    -Stwierdzone uczulenie na badany produkt lub którekolwiek jego składniki
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline in Hb averaged over week 28 to week 52.

    Major adverse cardiovascular (CV) events (MACE): Time to first occurrence of death from any cause, non-fatal myocardial infarction or non-fatal stroke.

    Średnia zmiana w stosunku do wartości początkowej poziomu hemoglobiny (Hb) uśredniona dla okresu od tygodnia 28 do 52.

    Ciężkie zdarzenia niepożądane dotyczące układu sercowo-naczyniowego S-N (MACE – ang. Major Adverse CV Event ): Czas do pierwszego wystąpienia zgonu z dowolnej przyczyny, zawału serca niezakończonego zgonem (MI) lub udaru mózgu niezakończonego zgonem.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization (week 0) to week 52.
    From randomization (week 0) to end of study (event-driven, anticipate up to 4 years).

    Od randomizacji (tydzień 0) do tygodnia 52.
    Od randomizacji (tydzień 0) do zakończenia badania (osiągnięcie docelowej liczby zdarzeń, szacowany czas trwania badania do 4 lat).
    E.5.2Secondary end point(s)
    1. Proportion of total time of Hb measurements within the interval of 11±1 g/dL from week 28 until end of treatment visit.
    2. Time to first rescue therapy (composite of erythropoietin analogue therapy [for roxadustat-allocated patients only] or RBC transfusion).
    3.Changes in self-reported health status as measured by the EuroQol Health Utility Index (EQ-5D-5L) during roxadustat or epoetin alfa treatment.
    4. 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.
    5. Time to first occurrence of death from any cause, non-fatal MI, nonfatal stroke, heart failure requiring hospitalization, unstable angina leading to hospitalization, vascular access thrombosis, deep vein thrombosis, pulmonary embolism or hypertensive emergency.
    6. Adverse events (AEs), serious adverse events (SAEs) Changes in vital signs, electrocardiogram (ECG) and laboratory values.
    1.Proporcja czasu, w którym wartość Hb wynosiła 11±1 g/dl w stosunku do całości czasu od tygodnia 28 do wizyty na zakończenie leczenia badanego.

    2.Czas do zastosowania pierwszej terapii ratunkowej (złożone kryterium), obejmującej przetoczenie krwinek czerwonych lub podanie rekombinowanej erytropoetyny (tylko u pacjentów leczonych roxadustatem) jako terapię ratunkową.

    3.Zmiany samooceny stanu zdrowia mierzonej przy użyciu kwestionariusza EQ-5D-5L podczas leczenia roxadustatem lub EPO.

    4.Ciężkie zdarzenia niepożądane dotyczące układu S-N+ (MACE+): czas do pierwszego wystąpienia zgonu z dowolnej przyczyny, zawału mięśnia sercowego niezakończonego zgonem, udaru niezakończonego zgonem, niewydolności serca wymagającej hospitalizacji lub niestabilnej piersiowej choroby wieńcowej powodującej hospitalizację

    5.Czas do pierwszego wystąpienia zgonu z dowolnej przyczyny, zawału mięśnia sercowego niezakończonego zgonem, udaru niezakończonego zgonem, niewydolności serca wymagającej hospitalizacji, niestabilnej choroby wieńcowej powodującej hospitalizację, zakrzepicy w miejscu dostępu naczyniowego, zakrzepicy żył głębokich lub zatorowości płucnej lub nagły wzrost ciśnienia tętniczego.

    6.Zdarzenia niepożądane (AE), ciężkie zdarzenia niepożądane (SAE). Zmiany podstawowych parametrów życiowych, elektrokardiogramu (EKG) oraz wyników badań laboratoryjnych.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From week 28 until end of study.
    2. From randomization (week 0) to end of study (event-driven, anticipate up to 4 years).
    3. At baseline, week 12, 28 and 52.
    4. From randomization (week 0) to end of study (event-driven, anticipate up to 4 years).
    5. From randomization (week 0) to end of study (event-driven, anticipate up to 4 years).
    6. From the first screening visit to the end of the study (event-driven, anticipate up to 4 years).



    1.od 28. tygodnia do zakończenia badania.
    2.od randomizacji (tydzień 0) do zakończenia badania (osiągnięcie docelowej liczby zdarzeń, szacowany czas trwania badania do 4 lat).
    3.dane wyjściowe, tydzień 12, 28 i 52.
    4.od randomizacji (tydzień 0) do zakończenia badania (osiągnięcie docelowej liczby zdarzeń, szacowany czas trwania badania do 4 lat).
    5.od randomizacji (tydzień 0) do zakończenia badania (osiągnięcie docelowej liczby zdarzeń, szacowany czas trwania badania do 4 lat).
    6.od pierwszej wizyty przesiewowej do zakończenia badania (osiągnięcie docelowej liczby zdarzeń, szacowany czas trwania badania do 4 lat).
    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
    Oszacowanie samooceny stanu zdrowia
    Ocena konieczności zastosowania terapii ratunkowej u pacjentów leczonych roxadustatem w porównaniu do terapii 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA71
    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 (Last Visit Last Subject)
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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: 1600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 526
    F.4.2.2In the whole clinical trial 2100
    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 end of treatment with study drug, patients should be managed according to local standard of care
    Po zakończeniu przyjmowania leczenia badanego pacjenci będą otrzymywali terapię zgodnie z lokalnym standardem leczenia.
    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 Decision2015-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-26
    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA