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    Summary
    EudraCT Number:2016-003896-24
    Sponsor's Protocol Code Number:D169AC00001
    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:2016-12-27
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-003896-24
    A.3Full title of the trial
    A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and
    Cardiovascular Mortality in Patients with Chronic Kidney Disease
    Ensayo Clínico para Evaluar el Efecto de Dapagliflozina sobre el Riesgo de Eventos Renales y Mortalidad Cardiovascular en Pacientes con Enfermedad Renal Crónica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate if dapagliflozin can prevent the gradual loss of kidney function and improve survival for patients with chronic kidney disease.
    Un estudio para evaluar si la dapagliflozina puede prevenir la perdida gradual de la función renal y mejorar la superviviencia en pacientes con enfermedad renal cronica.
    A.3.2Name or abbreviated title of the trial where available
    DAPA CKD
    DAPA CKD
    A.4.1Sponsor's protocol code numberD169AC00001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, SA
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache,56
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number0034900200444
    B.5.5Fax number----
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameDapagliflozin
    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 INNDAPAGLIFLOZIN PROPANEDIOL
    D.3.9.1CAS number 960404-48-02
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    D.2.1.1.1Trade name Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameDapagliflozin
    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 INNDAPAGLIFLOZIN PROPANEDIOL
    D.3.9.1CAS number 960404-48-2
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic kidney disease (CKD)
    Enfermedad renal cronica (ERC)
    E.1.1.1Medical condition in easily understood language
    Renal Disease: A gradual loss of kidney function leading to insufficient filtration of waste and excess fluid from the blood
    Enfermedad Renal: Pérdida gradual de la función renal que conduce a una filtración insuficiente de residuos y pérdida excesiva de fluidos en sangre
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if dapagliflozin is superior to placebo in reducing the incidence of the primary composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate (eGFR), reaching end stage renal disease (ESRD), CV or renal death when added to current background therapy in patients with eGFR ≥25 and ≤75 mL/min/1.73m2 and albuminuria (urine albumin creatinine ratio [UACR] ≥200 and ≤5000 mg/g)
    Determinar si dapagliflozina es superior frente al placebo reduciendo la incidencia de la variable primaria compuesta en la disminución sostenida de ≥50% en la tasa de filtración glomerular estimada (TFGe), alcanzando la enfermedad renal en etapa terminal (ERET), muerte cardiovascular o renal cuando se añade a la terapia actual basal en pacientes con TFGe ≥25 y ≤75 mL/min/1.73m2 y albuminuria (cociente albúmina/creatinina en orina [ACR] ≥200 y ≤5000 mg/g)
    E.2.2Secondary objectives of the trial
    1) To determine whether dapagliflozin compared with placebo will result in a reduction of the incidence of the composite endpoints of worsening of renal function

    2) To determine whether dapagliflozin compared with placebo will result in a reduction of the incidence of the composite endpoint of CV death or hospitalization for heart failure

    3) To determine whether dapagliflozin compared with placebo will result in a reduction of the incidence of all-cause mortality


    4) Safety Objective: To evaluate the safety and tolerability of dapagliflozin in this patient population
    1) Determinar si dapagliflozina en comparación con placebo dará como resultado una reducción de la incidencia de las variables compuestas en el empeoramiento de la función renal.

    2) Determinar si dapagliflozina en comparación con el placebo dará lugar a una reducción de la incidencia de las variables compuestas de muerte cardiovascular u hopitalización por insuficiencia cardíaca

    3) Determinar si dapagliflozina en comparación con placebo dará como resultado una reducción en la incidencia de la mortalidad por cualquier causa.

    4) Objetivo de Seguridad: Evaluar la seguridad y tolerabilidad de dapagliflozina en esta población de pacientes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Provision of signed informed consent prior to any study specific procedures

    • Female or male aged ≥18 years at the time of consent

    • eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula)

    • UACR ≥200 and ≤5000 mg/g at visit 1

    • Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated
    • Provisión de los consentimientos informados firmados antes de cualquier procedimiento específico de estudio

    • Hombre o mujer mayores≥18 años en el momento del consentimiento

    • TFGe ≥25 y ≤75 mL/min/1.73m2 (Ecuación CKD-EPI)

    • UACR ≥200 y ≤5000 mg/g en visita 1

    • Dosis máxima diaria tolerada y estable de tratamiento con IECA o ARA al menos 4 semanas antes de su primera visita, si no está clínicamente contraindicada.
    E.4Principal exclusion criteria
    • Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis

    • Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment

    • History of organ transplantation

    • Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor

    • Type 1 diabetes mellitus

    • New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment

    • MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
    • Enfermedad renal políquistica autosómica dominante o autosómica recesiva, nefritis lúpica o vasculitis asociadas a ANCA

    • Pacientes que estén recibiendo tratamiento citotóxico, inmunosupresores u otra inmunoterapia para la enfermedad renal primaria o secundaria dentro de los primeros 6 meses antes de la inclusión

    • Antecedentes de trasplante de órganos

    • Pacientes que estén recibiendo tratamiento de inhibidores de SGLT2 dentro de las 8 semanas antes de la inclusión o intolerancia anterior a los inhibidores de SGLT2

    • Diabetes Mellitus Tipo 1

    • Clase IV Insuficiencia Cardiovascular Congestiva según la escala NYHA (New York Heart Association) en el momento de la inclusión

    • IM, accidente cerebrovascular o ataque isquémico transitorio dentro de las 12 semanas anteriores a la inclusión
    E.5 End points
    E.5.1Primary end point(s)
    Time to the first occurrence of any of the components of this composite:
    1. ≥50% sustained decline in eGFR
    2. Reaching ESRD
     - Sustained eGFR <15 mL/min/1.73m2 or,
     - Chronic dialysis treatment or,
     - Receiving a renal transplant
    3. CV death
    4. Renal death
    Tiempo hasta la primera aparición de alguno de los componentes de este conjunto:
    1. ≥50% disminución sostenida del TFGe
    2. Alcanzar ERET
     - TFGe sostenida <15 mL/min/1.73m2 o,
     - Tratamiento de diálisis crónica o,
     - Transplante de órganos recibido
    3. Muerte CV
    4. Muerte Renal
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated when at least 100% of the primary events are adjudicated, which means at 681 adjudicated primary events.
    La variable principal será evaluada cuando al menos el 100% de los eventos primarios hayan sido adjudicados, lo que implica 681 eventos primarios adjudicados.
    E.5.2Secondary end point(s)
    1) Time to the first occurrence of any of the components of this composite:
    1. ≥50% sustained decline in eGFR
    2. Reaching ESRD
    3. Renal death

    2) Time to the first occurrence of either of the components of this composite:
    1. CV death
    2. Hospitalization for heart failure

    3) Time to death from any cause

    4) Safety endpoints:
    1. Serious adverse event (SAE)
    2. Discontinuation of investigational product (IP) due to adverse event (DAE)s
    3. Changes in clinical chemistry/haematology parameters
    4. AEs of interest (volume depletion, renal events, major hypoglycaemic events, fractures, diabetic ketoacidosis (DKA) and AEs leading to amputation)
    1) Tiempo hasta la primera aparición de alguno de los componentes de este conjunto:
    1. ≥50% disminución sostenida del TFGe
    2. Alcanzar ERET
    3. Muerte Renal

    2) Tiempo hasta la primera aparición de cualquiera de los componentes de este conjunto:
    1. Muerte CV
    2. Hospitalización por insuficiencia cardíaca

    3) TIempo hasta fallecimiento por cualquier causa.

    4) Variables de seguirdad:
    1. Acontecimiento Adverso Grave (SAE)
    2. Interrupción del medicamento en investigación (MI) debido a un acontecimiento adverso (DAE)s
    3. Cambios en los parámetros clínicos químicos/hematológicos
    4. AEs de interés (depleción de volumen, acontecimientos renales, acontecimientos importantes de hipoglucemia, fracturas, cetoacidosis diabética (DKA) y AEs que conducen a una amputación)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will only be evaluated once – and that is when the study stops, when at least 100% of the primary events are adjudicated.
    Las variables secundarias serán evaluadas sólo una vez- en este momento será cuando el estudio finalizará, cuando al menos el 100% de los eventos primarios hayan sido adjudicados.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker
    Biomarcador
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    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
    Brazil
    Canada
    China
    Denmark
    Germany
    Hungary
    India
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Poland
    Russian Federation
    Spain
    Sweden
    Ukraine
    United Kingdom
    United States
    Vietnam
    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
    The last visit of the last patient undergoing the study.
    La última visita del último paciente que se encuentre en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 2000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2000
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    When applicable a legally representative, together with impartial witness, is allowed to sign the informed consent of behalf of a patient (i.e. illiterate patients).
    Cuando sea aplicable, se permite a un representante legal, junto con un testigo imparcial, firmar el consentimiento informado de un paciente (es decir, pacientes analfabetos).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1040
    F.4.2.2In the whole clinical trial 4000
    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 Decision2017-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-09-28
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