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    Summary
    EudraCT Number:2013-000951-42
    Sponsor's Protocol Code Number:1517-CL-0610
    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:2013-10-31
    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 number2013-000951-42
    A.3Full title of the trial
    A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate
    the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Chronic
    Kidney Disease Patients Not on Dialysis
    Estudio de fase 3, aleatorizado, abierto y controlado con tratamiento activo para evaluar la eficacia y la seguridad de FG-4592 en el tratamiento de la anemia en pacientes con insuficiencia renal crónica no tratados con diálisis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FG-4592 in the treatment of anemia in chronic kidney disease patients
    FG-4592 en el tratamiento de la anemia en pacientes con insuficiencia renal crónica
    A.3.2Name or abbreviated title of the trial where available
    Dolomites
    A.4.1Sponsor's protocol code number1517-CL-0610
    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 SponsorAstellas Pharma Europe B.V.
    B.1.3.4CountryNetherlands
    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 supportAstellas Pharma Europe B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointService Desk - Global Clinical Dev.
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715455050
    B.5.5Fax number+31715455501
    B.5.6E-mailcontact@nl.astellas.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.3.2Product code FG-4592 20mg
    D.3.4Pharmaceutical form 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 codeFG-4592
    D.3.9.3Other descriptive nameASP1517
    D.3.9.4EV Substance CodeSUB89572
    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.3.2Product code FG-4592 - 50 mg
    D.3.4Pharmaceutical form 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 codeFG-4592
    D.3.9.3Other descriptive nameASP1517
    D.3.9.4EV Substance CodeSUB89572
    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.3.2Product code FG-4592 - 100 mg
    D.3.4Pharmaceutical form 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 codeFG-4592
    D.3.9.3Other descriptive nameASP1517
    D.3.9.4EV Substance CodeSUB89572
    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 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 nameAranesp 20 mcg 4 FS
    D.3.4Pharmaceutical form Solution for injection
    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 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 microgram(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 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: 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 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 nameAranesp 30 mcg 4 FS
    D.3.4Pharmaceutical form Solution for injection
    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 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 microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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 nameAranesp 40 mcg 4 FS
    D.3.4Pharmaceutical form Solution for injection
    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 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 microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 nameAranesp 60 mcg 4 FS
    D.3.4Pharmaceutical form Solution for injection
    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 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 microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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: 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 nameAranesp 100 mcg 4 FS
    D.3.4Pharmaceutical form Solution for injection
    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 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 microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    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 not on Dialysis
    Anemia en pacientes con insuficiencia renal crónica no tratados con diálisis
    E.1.1.1Medical condition in easily understood language
    Anemia in patients with chronic kidney disease
    Anemia en pacientes con insuficiencia renal crónica
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10002272
    E.1.2Term Anemia
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of FG-4592 compared to Darbepoetin alfa in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD)
    subjects.
    Evaluar la eficacia de FG-4592 en comparación con la darbepoetina alfa en el tratamiento de la anemia en sujetos con insuficiencia renal crónica (IRC) no sometidos a diálisis.
    E.2.2Secondary objectives of the trial
    Evaluate the safety of FG-4592 compared to Darbepoetin alfa in the treatment of anemia in non-dialysis CKD subjects.

    Evaluate the health-related quality of life (HRQoL) benefit of FG-4592 compared to Darbepoetin alfa in the treatment of anemia in non-dialysis CKD subjects.
    Evaluar la seguridad de FG-4592 en comparación con la darbepoetina alfa en el tratamiento de la anemia en sujetos con IRC no tratados con diálisis.

    Evaluar los beneficios de FG-4592 sobre la calidad de vida relacionada con la salud (CdVRS) en comparación con la darbepoetina alfa en el tratamiento de la anemia en sujetos con IRC no sometidos a diálisis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject is eligible for the study if all of the following apply:
    Subject age is ? 18 years.
    Subject has a diagnosis of CKD, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4 or 5, not on dialysis; with an eGFR <60 mL/min/1.73 m2 estimated using the abbreviated 4-variable Modification of Diet in Renal Disease (MDRD) equation.
    The mean of the subject?s three most recent (prior to randomization) Hb values during the Screening period, obtained at least 4 days apart, must be ?10.0 g/dL, with a difference of ?1.0 g/dL between the highest and the lowest values. The last Hb value must be within 10 days prior to randomization.
    Subject?s alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ?3 x upper limit of normal (ULN), and total bilirubin (TBL) is ?1.5 x ULN.
    Subject?s body weight is 45.0 kg to a maximum of 160.0 kg.
    El sujeto es apto para el estudio si se cumplen todas las condiciones siguientes:
    La edad del sujeto es ? 18 años
    Se le ha diagnosticado IRC, en el estadio 3, 4 o 5 según las Guías KDOQI (Iniciativa de Calidad para los Resultados de Insuficiencia Renal, Kidney Disease Outcomes Quality Initiative), y no se somete a diálisis; presenta una eGFR <60 ml/min/1,73 m2 calculada utilizando la ecuación de 4 variables de la modificación de la dieta en la insuficiencia renal (MDRD, Modification of Diet in Renal Disease)
    La media de los tres valores más recientes de Hb del sujeto durante el período de selección, obtenidos con al menos 4 días de diferencia entre sí, debe ser ? 10,0 g/dl, con una variación de ? 1,0 g/dl entre el más alto y el más bajo. El último valor de Hb debe ser de los 10 días anteriores a la aleatorización.
    La alanina aminotransferasa (ALAT) y el aspartato aminotransferasa (ASAT) del sujeto son ? 3 veces el límite superior de lo normal (LSN) y la bilirrubina total (BLT) es ? 1,5 x LSN
    El peso corporal del sujeto es desde 45 kg hasta un máximo de 160 kg.
    E.4Principal exclusion criteria
    Subject will be excluded from participation if any of the following apply:
    Subject has received any ESA treatment within 12 weeks prior to randomization.
    Subject has received any dose of IV iron within 6 weeks prior to randomization.
    Subject has received a Red Blood Cell (RBC) transfusion within 8 weeks prior to randomization
    Subject has a known chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission.
    Subject has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
    Subject has an uncontrolled hypertension in the opinion of the investigator, or two or more blood pressure values of systolic blood pressure (SBP) ?160 mmHg or diastolic blood pressure (DBP) ?95mmHg, within 2 weeks prior to randomization.
    El sujeto será excluido de toda participación si se da alguna de las siguientes situaciones:
    El sujeto ha recibido algún tratamiento con ESA en las 12 semanas previas a la aleatorización.
    El sujeto ha recibido alguna dosis de hierro IV en las 6 semanas previas a la aleatorización.
    El sujeto ha recibido una transfusión de glóbulos rojos en las 8 semanas previas a la aleatorización.
    El sujeto padece una enfermedad inflamatoria crónica conocida que podría afectar a la eritropoyesis (por ejemplo, lupus eritematoso sistémico, artritis reumatoide, celiaquía), incluso si está remitiendo actualmente
    El sujeto ha sufrido un infarto de miocardio, síndrome coronario agudo, ictus, convulsiones o un episodio trombótico/tromboembólico (por ejemplo, trombosis venosa profunda o embolia pulmonar) en las 12 semanas previas a la aleatorización.
    El sujeto presenta hipertensión no controlada, en opinión del investigador, o dos o más valores de presión arterial sistólica (PAS) ? 160 mmHg o diastólica (PAD) ? 95 mmHg, durante las 2 semanas previas a la aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is Hb response defined as:
    - Hb ?11.0 g/dL and a Hb increase from BL Hb by ?1.0 g/dL in any subject with BL Hb>8.0 g/dL, OR
    - An increase from BL Hb by ?2.0 g/dL in any subject with BL Hb ?8.0 g/dL as measured at 2 consecutive visits separated by at least 5 days during the first 24 weeks of treatment without administration of rescue therapy (i.e., RBC transfusion for all subjects or darbepoetin alfa for FG-4592 treated subjects) prior to Hb response.
    La variable principal de la eficacia es:
    - La respuesta de la Hb definida como: Hb ? 11,0 g/dl y un aumento de Hb ? 1,0 g/dl respecto a la Hb basal en cualquier sujeto con Hb basal > 8,0 g/dl, O BIEN
    - un aumento de Hb ? 2,0 g/dl respecto a la Hb basal en cualquier sujeto con Hb basal ? 8,0 g/dl, medida en 2 visitas consecutivas, separadas por al menos 5 días, en las primeras 24 semanas de tratamiento sin administración de tratamiento de rescate (es decir, transfusión de glóbulos rojos para todos los sujetos o darbepoetina alfa para los sujetos tratados con FG-4592) antes de la respuesta de la Hb.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 Weeks
    36 semanas
    E.5.2Secondary end point(s)
    - Hb change from BL Hb to the average Hb of weeks 28 to 36, without having received rescue therapy within 6 weeks prior to and during this 8-week evaluation period
    - Change from BL in Low Density Lipoprotein (LDL) cholesterol to the average LDL cholesterol of weeks 12 to 28
    - Mean monthly IV iron (mg) use per subject during weeks 1 to 36
    (monthly defined as a period of 4 weeks)
    - Blood pressure effect:
    o Change from BL in mean arterial pressure (MAP) to the average MAP value of weeks 20 to 28
    o Occurrence of hypertension (SBP >170 mmHg or DBP >110 mmHg, or an increase from BL of ?15 mmHg [DBP] or ?20 mmHg [SBP] on 2 consecutive visits) or intensification of antihypertensive therapy during weeks 1 to 36
    - Change from BL in SF-36 Physical Functioning (PF) sub-score to the average PF subscore of weeks 12 to 28
    - Change from BL in SF-36 Vitality (VT) sub-score to the average VT subscore of weeks 12 to 28
    - Cambio en la Hb desde el valor de referencia (Hb basal) a la Hb promedio de las semanas 28 a 36, sin haber recibido tratamiento de rescate en las 6 semanas previas y durante este período de evaluación de 8 semanas.
    - Cambio en el colesterol de lipoproteína de baja densidad (LDL) de referencia al colesterol LDL promedio de las semanas 12 a 28.
    - Administración de hierro IV mensual (mg) promedio por sujeto durante las semanas 1 a 36 (definiéndose mensual como un período de 4 semanas).
    - Efecto sobre la presión arterial:
    o Cambio desde el valor de referencia en la presión arterial media (PAM) al valor promedio de PAM en las semanas 20 a 28.
    o Aparición de hipertensión (PAS >170 mmHg o PAD >110 mmHg o un aumento desde el valor de referencia de ? 15 mmHg [PAD] o ? 20 mmHg [PAS] en 2 visitas consecutivas) o intensificación del tratamiento antihipertensivo durante las semanas 1 a 36.
    - Cambio desde el valor de referencia en la puntuación secundaria de función física (FF) de la SF-36 a la puntuación secundaria FF promedio de las semanas 12 a 28.
    - Cambio desde el valor de referencia en la puntuación secundaria de vitalidad (VT) de la SF-36 a la puntuación secundaria VT promedio de las semanas 12 a 28.
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 weeks
    36 semanas
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA92
    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
    Austria
    Croatia
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Ireland
    Israel
    Latvia
    Netherlands
    Portugal
    Slovakia
    Slovenia
    Spain
    Sweden
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 170
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 530
    F.4.2.2In the whole clinical trial 570
    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 Decision2013-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-06
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