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    The EU Clinical Trials Register currently displays   37700   clinical trials with a EudraCT protocol, of which   6177   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-000507-86
    Sponsor's Protocol Code Number:201410
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-000507-86
    A.3Full title of the trial
    A 52-week open-label (sponsor-blind), randomized, active controlled,
    parallel-group, multi-center study to evaluate the
    efficacy and safety of daprodustat compared to recombinant
    human erythropoietin in subjects with anemia associated with
    chronic kidney disease who are initiating dialysis
    Estudio de 52 semanas aleatorizado, abierto (con el promotor enmascarado), con control activo, en grupos paralelos, multicéntrico para evaluar la seguridad y eficacia de daprodustat en comparación con eritropoyetina recombinante humana en pacientes con anemia asociada a enfermedad renal crónica que inician diálisis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Anemia Studies in CKD: Erythropoiesis via a Novel PHI
    Daprodustat- in Incident Dialysis
    Estudios de la anemia asociada a IRC: eritropoyesis mediante Daprodustat, un nuevo PHI para la diálisis de paciente de nuevo diagnóstico.
    A.3.2Name or abbreviated title of the trial where available
    ASCEND-ID
    ASCEND-ID
    A.4.1Sponsor's protocol code number201410
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number34900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 nameDaprodustat
    D.3.2Product code GSK1278863
    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 INNdaprodustat
    D.3.9.1CAS number 960539-70-2
    D.3.9.2Current sponsor codeGSK1278863A (A denotes the free
    D.3.9.3Other descriptive nameGSK1278863
    D.3.9.4EV Substance CodeSUB72830
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 nameDaprodustat
    D.3.2Product code GSK1278863
    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 INNdaprodustat
    D.3.9.1CAS number 960539-70-2
    D.3.9.2Current sponsor codeGSK1278863A (A denotes the free
    D.3.9.3Other descriptive nameGSK1278863
    D.3.9.4EV Substance CodeSUB72830
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 nameDaprodustat
    D.3.2Product code GSK1278863
    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 INNdaprodustat
    D.3.9.1CAS number 960539-70-2
    D.3.9.2Current sponsor codeGSK1278863A (A denotes the free
    D.3.9.3Other descriptive nameGSK1278863
    D.3.9.4EV Substance CodeSUB72830
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDaprodustat
    D.3.2Product code GSK1278863
    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 INNdaprodustat
    D.3.9.1CAS number 960539-70-2
    D.3.9.2Current sponsor codeGSK1278863A (A denotes the free
    D.3.9.3Other descriptive nameGSK1278863
    D.3.9.4EV Substance CodeSUB72830
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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: 5
    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 nameDaprodustat
    D.3.2Product code GSK1278863
    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 INNdaprodustat
    D.3.9.1CAS number 960539-70-2
    D.3.9.2Current sponsor codeGSK1278863A (A denotes the free
    D.3.9.3Other descriptive nameGSK1278863
    D.3.9.4EV Substance CodeSUB72830
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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: 6
    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 nameDaprodustat
    D.3.2Product code GSK1278863
    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 INNdaprodustat
    D.3.9.1CAS number 960539-70-2
    D.3.9.2Current sponsor codeGSK1278863A (A denotes the free
    D.3.9.3Other descriptive nameGSK1278863
    D.3.9.4EV Substance CodeSUB72830
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Aranesp
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B. V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDarbepoetin alfa
    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 IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARBEPOETIN ALFA
    D.3.9.1CAS number 209810-58-2
    D.3.9.4EV Substance CodeSUB12486MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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 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 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: 8
    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 Aranesp
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B. V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDarbepoetin alfa
    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 IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARBEPOETIN ALFA
    D.3.9.1CAS number 209810-58-2
    D.3.9.4EV Substance CodeSUB12486MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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: 9
    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 Aranesp®
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B. V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDarbepoetin alfa
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARBEPOETIN ALFA
    D.3.9.1CAS number 209810-58-2
    D.3.9.4EV Substance CodeSUB12486MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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: 10
    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 Aranesp®
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B. V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDarbepoetin alfa
    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 IMPIntrauterine use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARBEPOETIN ALFA
    D.3.9.1CAS number 209810-58-2
    D.3.9.4EV Substance CodeSUB12486MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anemia associated with chronic kidney disease
    Anemia asociada a enfermedad renal crónica
    E.1.1.1Medical condition in easily understood language
    Anemia associated with chronic kidney disease
    Anemia asociada a enfermedad renal crónica
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    To compare daprodustat to rhEPO for Hgb efficacy (non-inferiority)
    Comparar daprodustat con EPO rHu en cuanto a eficacia de Hgb (no inferioridad).
    E.2.2Secondary objectives of the trial
    To compare daprodustat to rhEPO on the use of intravenous (IV) iron
    Comparar daprodustat con EPO rHu respecto al uso de hierro
    intravenoso (IV)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria apply at screening and randomization (Day 1) unless otherwise specified.
    1. Age (confirm at screening): 18 to 99 years of age inclusive
    2. Dialysis: Planning to start chronic dialysis within the next 4 weeks (from the date of the screening visit) OR have started and received dialysis (as specified below) for end-stage renal disease for a maximum of ≤90 days immediately prior to randomization and is not expected to stop dialysis during the duration of the trial:
    - HD ≥ 2X/week, or
    - Daily PD (Including continuous and automated PD)
    3. Hemoglobin concentration as measured by HemoCue (range inclusive): 8-10.5 g/dL (5-6.5 mmol/L) at screening and 8-11.0 g/dL (5-6.8 mmol/L) at randomization
    4. Informed consent: capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol
    Note: The country-specific requirements for France ONLY for the informed consent process is provided in Appendix 11 (see Section 12.11.1, Item 3 for details)
    5. Other study eligibility criteria considerations: The country-specific requirements for France ONLY for the eligibility for inclusion in this study is provided in Appendix 11 (see Section 12.11.1, Item 1 for details)
    Un paciente solamente podrá participar en este estudio si cumple todos los criterios siguientes en la selección y la aleatorización (día 1), a menos que se especifique lo contrario.
    1. Edad (confirmar en la selección): 18 a 99 años, ambos inclusive.
    2. Diálisis: que planee iniciar la diálisis crónica durante las 4 semanas siguientes (desde la fecha de la visita de selección) O que haya iniciado y recibido diálisis (como se especifica a continuación) para la enfermedad
    renal en su etapa final durante, como máximo, ≤90 días inmediatamente antes de la aleatorización y que no prevea interrumpir la diálisis mientras dure el ensayo:
    •HD ≥ 2 veces/semana o
    •PD diaria (incluida la PD continua y automatizada)
    3. Concentración de hemoglobina medida mediante HemoCue (rango inclusivo): 8-10,5 g/dL (5-6,5 mmol/L) en la selección y 8-11,0 g/dL (56,8 mmol/L) en la aleatorización
    4.Consentimiento informado: capaz de proporcionar un consentimiento informado firmado que incluya el cumplimiento de los requisitos y las restricciones enumeradas en el formulario de consentimiento y en este
    protocolo.
    E.4Principal exclusion criteria
    A subject will not be eligible for participation in this study if any of the following criteria apply at screening or at randomization (Day 1), unless otherwise specified.
    CKD-related criteria
    1. Kidney transplant: Planned living-related donor kidney transplant during the study.
    Anemia related criteria
    2. Ferritin: ≤100 ng/mL (≤100 µg/L) at screening or after IV iron supplementation.
    3. TSAT: ≤20% at screening or after IV iron supplementation.
    4. Vitamin B12: Below the lower limit of the reference range at screening or after vitamin B12 supplementation
    5. Folate: <2.0 ng/mL (<4.5 nmol/ L) at screening
    6. Aplasias: History of bone marrow aplasia or pure red cell aplasia (PRCA).
    7. Other causes of anemia: Pernicious anemia, thalassemia major, sickle cell disease, or myelodysplastic syndrome.
    8. Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease OR clinically significant GI bleeding ≤10 weeks prior to screening through to randomization (Day 1).
    Erythropoiesis treatment criteria
    9. Use of any ESA treatment within 8 weeks prior to screening except for limited use as part of dialysis initiation. Limited use is defined as no more than 6 weeks of short acting ESA (rhEPO or biosimilars; maximum of 20000 U total) or long acting ESA (darbepoetin alfa [maximum of 100 µg total] or methoxy polyethylene glycol-epoetin beta [maximum of 125 µg total]) received before or after starting dialysis.
    Cardiovascular disease-related criteria
    10. Myocardial infarction or acute coronary syndrome: ≤10 weeks prior to screening through to randomization (Day 1).
    11. Stroke or transient ischemic attack: ≤10 weeks prior to screening through to randomization (Day 1).
    12. Heart failure: Chronic Class IV heart failure, as defined by the New York HeartAssociation (NYHA) functional classification system.
    13. Current uncontrolled hypertension: Current uncontrolled hypertension as determined by the Investigator that would contraindicate the use of rhEPO.
    14. QTcB (Day 1): QTcB >500 msec, or QTcB >530 msec in subjects with bundle branch block. There is no QTc exclusion for subjects with a predominantly paced rhythm
    Other disease-related criteria
    15. Liver disease (any one of the following):
    - Alanine transaminase (ALT) >2x upper limit of normal (ULN) (screening only)
    - Bilirubin >1.5xULN (screening only)
    NOTE: Isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%.
    - Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
    NOTE: Stable chronic liver disease (including asymptomatic gallstones, chronic hepatitis B or C, or Gilbert's syndrome) are acceptable if subjectotherwise meets entry criteria.
    16. Malignancy: History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (i.e. Bosniak Category II F, III or IV) > 3cm. The only exception is localized squamous cell or basal cell carcinoma of the skin that has been definitively treated ≥10 weeks prior to screening. Concomitant medications and other study treatment-related criteria
    17. Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (refer to daprodustat IB) or to darbepoetin alfa (refer to product labelling)
    18. Drugs and supplements (randomization only): Use of strong CYP2C8 inhibitors (e.g., gemfibrozil) or strong CYP2C8 inducers (e.g., rifampin/rifampicin).
    19. Prior investigational product exposure: Use of an investigational drug (other than daprodustat – see next criterion) ≤30 days or within five half-lives of the investigational agent, whichever is longer prior to screening.
    20. Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of > 30 days.
    General health-related criteria
    21. Females ONLY: Subject is pregnant [as confirmed by a positive serum human chorionic gonadotropin (hCG) test for females of reproductive potential (FRP) only], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the contraceptive options in the List of Highly Effective Methods for Avoiding Pregnancy listed in Appendix 5.
    22. Other Conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g., intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.
    Criterios relacionados con la ERC
    1.Trasplante de riñón: previsión de trasplante de riñón de donante vivo relacionado durante el estudio.
    Criterios relacionados con la anemia
    2.Ferritina: 100 ng/mL (100 g/L) en la selección o después de la aportación suplementaria de hierro IV.
    3.TSAT: 20 % en la selección o después de la aportación suplementaria de hierro IV.
    4.Vitamina B12: por debajo del límite inferior del intervalo de referencia en la selección o después de la aportación suplementaria de vitamina B12
    5.Folato: <2,0 ng/mL (<4,5 nmol/ L) en la selección
    6.Aplasias: antecedentes de aplasia de médula ósea o aplasia pura de serie roja.
    7.Otras causas de anemia: anemia perniciosa, talasemia mayor, enfermedad de células falciformes o síndrome mielodisplásico.
    8.Sangrado gastrointestinal: evidencia de sangrado gástrico, duodenal o úlcera esofágica O sangrado GI clínicamente significativo ≤10 semanas antes de la selección hasta la aleatorización (día 1).
    Criterios de tratamiento de la eritropoyesis
    9.Uso de cualquier tratamiento con AEE durante las 8 semanas
    anteriores a la selección, excepto el uso limitado como parte del inicio de la diálisis. El uso limitado se define como no más de 6 semanas de AEE de acción breve (EPO rHu o biosimilares; máximo de 20 000 U en total) o
    AEE de acción larga (darbepoetina alfa [máximo de 100 g en total] o metoxi-polietilenglicol epoetina beta [máximo de 125 g en total]) recibidos antes o después de iniciar la diálisis.
    Criterios relacionados con la enfermedad cardiovascular
    10. Infarto de miocardio o síndrome coronario agudo: ≤10 semanas
    antes de la selección hasta la aleatorización (día 1).
    11. Ictus o accidente isquémico transitorio: ≤10 semanas antes de la selección hasta la aleatorización (día 1).
    12. Fallo cardíaco: fallo cardíaco de clase IV crónico, según la definición del sistema de clasificación funcional de la NYHA.
    13. Hipertensión incontrolada actual: hipertensión incontrolada actual, de acuerdo con lo que establezca el investigador, que contraindique el uso de EPO rHu.
    14. QTcB (día 1): QTcB >500 msec, o QTcB >530 ms en pacientes con bloqueo de rama. No hay exclusión de QTc para los pacientes que tengan un ritmo predominantemente regular
    Otros criterios relacionados con la enfermedad
    15. Enfermedad hepática (cualquiera de las siguientes):
    • Alanina transaminasa (ALT) >2 x el límite superior de la normalidad
    (LSN) (solo selección)
    • Bilirrubina >1,5 x LSN (solo selección). La bilirrubina aislada >1,5 x
    LSN es aceptable si la bilirrubina es fraccionada y la bilirrubina directa <35 %.
    • Enfermedad hepática o biliar actual inestable según la evaluación del
    investigador, definida en general por la presencia de ascitis, encefalopatía, coagulopatía, hipoalbuminemia, varices esofágicas o gástricas, ictericia persistente o cirrosis. NOTA: La enfermedad hepática
    crónica estable son aceptables.
    16. Neoplasia maligna: antecedentes de neoplasia maligna durante los 2 años anteriores a la selección y hasta la aleatorización (día 1), o recibir actualmente tratamiento para el cáncer o quiste de riñón complejo (categoría Bosniak II F, III o IV) > 3 cm. La única excepción es el carcinoma localizado de células escamosas o basocelular en la piel cuyo tratamiento haya finalizado de manera definitiva 10 semanas antes de la selección.
    Medicamentos concomitantes y otros criterios relacionados con el
    tratamiento del estudio
    17. Reacciones alérgicas graves: antecedentes de reacciones alérgicas o anafilácticas graves o hipersensibilidad a excipientes presentes en el producto en investigación o a darbepoetina alfa
    18. Fármacos y suplementos (solo aleatorización): uso de inhibidores fuertes de CYP2C8 o inductores fuertes de CYP2C8.
    19. Exposición anterior al producto en investigación: uso de un fármaco en investigación (diferente de daprodustat, consulte el siguiente criterio) en un plazo de 30 días o cinco semividas del agente en
    investigación, lo que sea más largo, antes de la selección.
    20. Tratamiento previo con daprodustat: cualquier tratamiento anterior con daprodustat mientras dure el tratamiento de > 30 días.
    Criterios relacionados con la salud en general
    21. SOLO para mujeres: la paciente está embarazada (como se confirma a través de una prueba positiva de gonadotropina coriónica humana [hCG] en suero solo para mujeres con potencial reproductivo [FRP por
    sus siglas en ingl.]), está amamantando o tiene potencial reproductivo y no acepta seguir una de las opciones anticonceptivas que figuran en la Lista de métodos altamente eficaces para evitar el embarazo del Apéndice 5.
    22. Otras enfermedades: cualquier otra enfermedad, anomalía clínica o analítica o resultado de examen que, según el criterio del investigador, pueda suponer un riesgo inaceptable para el paciente, que pueda afectar
    a la adecuación al estudio o que impida entender los objetivos, los procedimientos de la investigación o las posibles consecuencias del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in Hgb between baseline and evaluation period (EP, mean over Weeks 28-52)
    El cambio medio que se produzca en la Hgb desde el inicio y el periodo
    de evaluación (PE, media a lo largo de las semanas 28-52).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between week 28 and week 52
    Entre semana 28 y semana 52.
    E.5.2Secondary end point(s)
    Average monthly IV iron dose (mg)/subject from baseline to Week 52
    Dosis mensual media de hierro IV (mg) /paciente desde el inicio hasta la
    semana 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between baseline and Week 52
    Entre el inicio y la semana 52
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Canada
    France
    Germany
    India
    Italy
    Korea, Republic of
    Malaysia
    Mexico
    Poland
    Russian Federation
    South Africa
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 79
    F.4.2.2In the whole clinical trial 300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of care
    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 Decision2017-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-10
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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