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    Summary
    EudraCT Number:2016-003896-24
    Sponsor's Protocol Code Number:D169AC00001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-25
    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 ConcernedPoland - Office for Medicinal Products
    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
    Badanie oceniające wpływ dapagliflozyny na punkty końcowe dotyczące nerek i śmiertelność z przyczyn sercowo-naczyniowych u pacjentów z przewlekłą chorobą nerek
    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.
    Badanie oceniające, czy dapagliflozyna może zapobiec stopniowej utracie czynności nerek i wydłużyć przeżycie pacjentów z przewlekła chorobą nerek.
    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
    B.5.2Functional name of contact pointInformation center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@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)
    Przewlekła choroba nerek (PChN)
    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
    Choroba nerek: stopniowa utrata czynności nerek prowadząca do niewystarczającej filtracji krwi ze zbędnych substancji i nadmiaru płynów z krwi.
    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)
    Określenie przewagi dapagliflozyny nad placebo pod względem redukowania częstości występowania pierwszorzędowego złożonego punktu końcowego, którym jest trwałe obniżenie o ≥50% szacunkowej filtracji kłębuszkowej (eGFR), osiągnięcie stadium schyłkowej choroby nerek (SChN), zgon z przyczyn SN/nerkowych, po dołączeniu do podstawowego leczenia u pacjentów z eGFR ≥25 i ≤75 ml/min/1,73 m2 i albuminurią (stosunkiem albumin do kreatyniny w moczu [UACR] ≥200 i ≤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) Określenie, czy dapagliflozyna, w porównaniu z placebo, zmniejsza częstość występowania złożonego punktu końcowego dotyczącego pogorszenia czynności nerek.
    2) Określenie, czy dapagliflozyna, w porównaniu z placebo, zmniejsza częstość występowania złożonego punktu końcowego obejmującego zgon z przyczyn SN lub hospitalizację z powodu niewydolności serca
    3) Określenie, czy dapagliflozyna, w porównaniu z placebo, zmniejsza ryzyko zgonu z dowolnej przyczyny.
    4) Ocena bezpieczeństwa i tolerancji dapagliflozyny u badanej populacji pacjentów.
    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) at visit 1

    • Evidence of increased albuminuria 3 months or more before visit 1 and
    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
    1. Udzielenie pisemnej świadomej zgody przed wykonaniem jakichkolwiek procedur związanych z badaniem.
    2. Kobiety lub mężczyźni w wieku ≥18 lat w chwili wyrażania zgody.
    3. eGFR ≥25 i ≤75 ml/min/1,73 m2 (wzór CKD-EPI) podczas wizyty 1.
    4. Udokumentowany wzrost obecność ciał białkowych w moczu (albuminuria) w okresie 3 miesięcy lub więcej przed wizytą nr 1 i wartość UACR ≥200 i ≤5000 mg/g podczas wizyty 1.
    5. Leczenie z zastosowaniem ACE I lub ARB w stabilnej i maksymalnej tolerowanej przez danego pacjenta, zgodnej z drukami informacyjnymi dawce dobowej, przez co najmniej 4 tygodnie przed wizytą 1., o ile nie występują przeciwwskazania medyczne.
    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





    1. Autosomalna dominująca lub autosomalna recesywna torbielowatość nerek, toczniowe zapalenie nerek lub zapalenie naczyń związane z ANCA.
    2. Otrzymywanie terapii cytotoksycznej, terapii immunosupresyjnej lub innych form immunoterapii z powodu pierwotnej lub wtórnej choroby nerek w okresie 6 miesięcy przed włączeniem do badania.
    3. Przeszczep narządu w wywiadzie.
    4. Otrzymywanie leczenia inhibitorem SGLT2 w okresie 8 tygodni przed włączeniem do badania lub wcześniejsze stwierdzenie nietolerancji inhibitora SGLT2.
    5. Cukrzyca typu 1 (T1D).
    6. Niewydolność serca klasy IV według Nowojorskiego Towarzystwa Kardiologicznego (NYHA) w chwili włączenia do badania (patrz załącznik C).
    7. Zawał mięśnia sercowego (MI), niestabilna dławica piersiowa, udar mózgu lub przemijający atak niedokrwienny (TIA) w okresie 12 tygodni przed włączeniem do badania.
    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

    Czas do pierwszego wystąpienia któregokolwiek z elementów tego złożonego punktu końcowego:
    1. Trwałe obniżenie eGFR o ≥50%.
    2. Osiągnięcie stadium SChN
    - Utrwalona wartość eGFR
    <15 ml/min/1,73 m2 lub
    - Przewlekła dializoterapia lub
    - Otrzymanie przeszczepu nerki
    3. Zgon z przyczyn SN.
    4. Zgon z przyczyn nerkowych.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated when at least 681 primary events has been confirmed.
    Ocena pierwszorzędowego punku końcowego będzie miała miejsce po potwierdzeniu wystąpienia co najmniej 681 zdarzeń pierwszorzędowych.
    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), AEs leading to amputation and AEs leading to risk for lower limb amputations
    ["precedin events"]).
    1) Czas do pierwszego wystąpienia któregokolwiek z elementów tego złożonego punktu końcowego:
    1. Trwałe obniżenie eGFR o ≥50%.
    2. Osiągnięcie stadium SChN.
    3. Zgon z przyczyn nerkowych.
    2) Czas do pierwszego wystąpienia któregokolwiek z elementów tego złożonego punktu końcowego:
    1. Zgon z przyczyn SN.
    2. Hospitalizacja z powodu niewydolności serca.
    3) Czas do wystąpienia zgonu z dowolnej przyczyny.
    4) Punkty końcowe dotyczące bezpieczeństwa:
    1. Poważne zdarzenie niepożądane (SAE).
    2. Przerwanie stosowania badanego produktu (IP) z powodu AE (DAE).
    3. Zmiany wyników badań biochemicznych/morfologii krwi.
    4. Zdarzenia niepożądane (AE) o szczególnym znaczeniu (zmniejszenie objętości osocza, zdarzenia dotyczące nerek, poważne epizody hipoglikemii, złamania, cukrzycowa kwasica ketonowa (DKA) oraz AE prowadzące do amputacji i AE prowadzące do ryzyka amputacji kończyny dolnej [„wydarzenia poprzedzające”]).
    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 681 primary events has been confirmed.
    Drugorzędowe punkty końcowe będą oceniane tylko jeden raz – i ta ocena będzie miała miejsce po zakończeniu badania, kiedy potwierdzone zostanie wystąpienie co najmniej 681 zdarzeń pierwszorzędowych.
    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
    biomerker
    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 concerned20
    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.
    Ostatnia wizyta ostatniego pacjenta uczestniczącego w badaniu
    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 months8
    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).
    Przedstawiciel prawny, w obecności 2 bezstronnych świadków, mogą podpisać formularz zgody w imieniu pacjenta (tzn. pacjent niepiśmienny) - jeżeli dotyczy).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    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
    Nie dotyczy
    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 Decision2017-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-14
    P. End of Trial
    P.End of Trial StatusOngoing
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