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    Summary
    EudraCT Number:2016-000838-21
    Sponsor's Protocol Code Number:AKB-6548-CI-0016
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-000838-21
    A.3Full title of the trial
    Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects with Incident Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE-CORRECTION)
    Studio di Fase 3, randomizzato, in aperto, con controllo attivo volto a valutare l'efficacia e la sicurezza di vadadustat somministrato per via orale per la correzione dell'anemia nei soggetti con malattia renale cronica dipendente da dialisi incidente (Dialysis-Dependent Chronic Kidney Disease, DD-CKD) (INNO2VATE-CORRECTION)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety study to evaluate vadadustat in the correction of anemia in subjects with dialysis-dependent chronic kidney disease (DD-CKD)
    Studio a valutare l'efficacia e la sicurezza di vadadustat per la correzione dell'anemia nei soggetti con malattia renale cronica dipendente da dialisi incidente
    A.3.2Name or abbreviated title of the trial where available
    INNO2VATE-CORRECTION
    INNO2VATE-CORRECTION
    A.4.1Sponsor's protocol code numberAKB-6548-CI-0016
    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 SponsorAKEBIA THERAPEUTICS, INC.
    B.1.3.4CountryUnited States
    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 supportAkebia Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles Transnational Corp.
    B.5.2Functional name of contact pointProject Lead
    B.5.3 Address:
    B.5.3.1Street AddressStrandbodgatan 1
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post codeSE-751 45
    B.5.3.4CountrySweden
    B.5.4Telephone number0046184311155
    B.5.5Fax number0046184311430
    B.5.6E-mailbodil.svanberg@quintiles.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 nameVadadustat
    D.3.2Product code AKB-6548
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1000025-07-9
    D.3.9.2Current sponsor codeAKB-6548
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARBEPOETINA ALFA
    D.3.9.1CAS number 11096-26-7
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameDARBEPOETINA ALFA
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARBEPOETINA ALFA
    D.3.9.1CAS number 11096-26-7
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameDARBEPOETINA ALFA
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Subjects with Incident Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
    Anemia nei soggeti con malattia renale cronica dipendente da dialisi incidente
    E.1.1.1Medical condition in easily understood language
    Decrease of hemoglobin in the blood of patients suffering from end-stage kidney disease who require dialysis
    Diminuzione di emoglobina nel sangue di pazienti affetti da malattia renale allo stadio terminale che necessitano di dialisi
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076412
    E.1.2Term Chronic kidney disease stage 5
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the efficacy and safety of vadadustat compared with darbepoetin alfa for the correction and maintenance of HGB in subjects with anemia secondary to CKD who have recently initiated dialysis treatment for end-stage renal disease.
    Dimostrare l’efficacia e la sicurezza di vadadustat rispetto a darbepoetina per la correzione e il mantenimento dell’HGB in soggetti con anemia secondaria alla malattia renale cronica (chronic kidney disease, CKD) che hanno recentemente iniziato un trattamento con dialisi per malattia renale terminale.
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ≥ 18 years of age
    2. Initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease within 16 weeks prior to Screening
    3. Mean Screening hemoglobin < 10.0 g/dL
    1. Età ≥18 anni
    2. Dialisi cronica di mantenimento (peritoneale o emodialisi) per la malattia renale terminale entro 16 settimane prima dello screening.
    3. HGB media allo screening <10,0 g/dl
    E.4Principal exclusion criteria
    1. Received more than 1 dose of long-acting (e.g., darbepoetin alfa, methoxy polyethylene glycol-epoetin beta [Mircera, C.E.R.A.]) or 2 doses
    of short acting eryhropoiesis-stimulating agent (ESA) (e.g., recombinant human erythropoietin [rHuEPO]) within 8 weeks prior to Screening.
    Subjects may not receive any ESA during the Screening period.
    2. Uncontrolled hypertension
    3. Severe heart failure at or during screening (New York Heart Association)
    4. Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), urgent coronary revascularisation, hospitalization for Congestive Heart Failure, or stroke within 12 weeks prior to screening
    5. Hypersensitivity to darbepoetin or vadadustat, or to any of their excipients
    1. Assunzione di più di 1 dose di ESA a lunga durata d’azione (ad es. darbepoetina alfa, metossi polietilene glicole-epoetina beta [Mircera, C.E.R.A]) o 2 dosi di ESA a breve durata d’azione (ad es. eritropoietina umana ricombinante [recombinant human erythropoietin, rHuEPO]) entro 8 settimane prima dello screening. I soggetti non possono ricevere ESA durante il periodo di screening.
    2. Ipertensione incontrollata
    3. Grave insufficienza cardiaca allo screening o durante lo screening stesso (classe IV della New York Heart Association)
    4. Sindrome coronarica acuta (ricovero per angina instabile, infarto miocardico); intervento chirurgico o percutaneo per malattia coronarica, cerebrovascolare o arteriopatia periferica (aortica o delle estremità inferiori); sostituzione o riparazione valvolare chirurgica o percutanea; tachicardia ventricolare prolungata; ricovero per CHF; o ictus entro 12 settimane prima dello screening o durante lo screening stesso.
    5. Ipersensibilità a vadadustat, darbepoetina alfa o qualsiasi loro eccipiente.
    E.5 End points
    E.5.1Primary end point(s)
    1. Mean change in HGB between Baseline and the primary evaluation period
    2. Major adverse cardiovascular events (MACE), defined as all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke
    1. Variazione media dell’HGB tra il basale e il periodo della valutazione primaria
    2. MACE, definito come mortalità per tutte le cause, infarto del miocardio non fatale o ictus non fatale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline visit, week 36
    2. From Baseline visit to end of study
    1. Baseline visit, week 36
    2. From Baseline visit to end of study
    E.5.2Secondary end point(s)
    Efficacy
    1. Mean change in hemoglobin value between Baseline and the secondary evaluation period
    2. Proportion of subjects with mean HGB within the target range during the primary evaluation period

    Safety
    3. AEs and SAEs
    Efficacia
    1. Variazione media dell’HGB tra il basale e il periodo della valutazione secondaria
    2. Percentuale di soggetti con HGB media entro l’intervallo target durante il periodo della valutazione primaria

    Sicurezza
    3. Eventi avversi (EA) ed eventi avversi seri (serious adverse event, SAE).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline visit, Week 52
    2. Baseline visit, Week 36
    3. From Baseline visit to end of study
    1. Baseline visit, Week 52
    2. Baseline visit, Week 36
    3. From Baseline visit to end of study
    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 Yes
    E.8.2.3.1Comparator description
    Darbepoetin alfa
    Darbepoetin alfa
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Mexico
    Russian Federation
    Ukraine
    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
    LVLS
    Ultima visita dell'utimo paziente
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 284
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 116
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 408
    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, normal treatment
    Standard of care, normal treatment
    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 Decision2017-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-03
    P. End of Trial
    P.End of Trial StatusCompleted
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