Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-002971-24
    Sponsor's Protocol Code Number:1245-0137
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-002971-24
    A.3Full title of the trial
    A multicentre international randomized parallel group double-blind placebo-controlled clinical trial of EMPAgliflozin once daily to assess cardio-renal outcomes in patients with chronic KIDNEY disease
    Studio clinico multicentrico internazionale randomizzato in doppio cieco controllato con placebo per valutare l’effetto di empagliflozin, una volta al giorno, sugli esiti cardio-renali in pazienti con insufficienza renale cronica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EMPA-KIDNEY (The study of heart and kidney protection with empagliflozin)
    EMPA-KIDNEY (Studio per la protezione del cuore e dei reni con empagliflozin)
    A.3.2Name or abbreviated title of the trial where available
    The EMPA-KIDNEY Study
    Studio EMPA-KIDNEY
    A.4.1Sponsor's protocol code number1245-0137
    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 SponsorBOEHRINGER INGELHEIM INTERNATIONAL GMBH
    B.1.3.4CountryGermany
    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 supportBoehringer Ingelheim
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number0018002430127
    B.5.5Fax number0018008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 Jardiance
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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 nameEmpagliflozin
    D.3.2Product code [BI10773]
    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 INNempagliflozin
    D.3.9.1CAS number 864070-44-0
    D.3.9.2Current sponsor codeBI10773
    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 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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic kidney disease
    Malattia renale cronica
    E.1.1.1Medical condition in easily understood language
    Long-standing problem with kidney function
    Problema di lunga durata dovuto alla funzione renale
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main question is whether taking an empagliflozin pill once a day compared to an inactive pill (placebo) prevents worsening of kidney disease or death from heart disease in people with kidney disease.
    La domanda principale è se l'assunzione di una compressa di empagliflozin una volta al giorno rispetto a una compressa inattiva (placebo) previene il peggioramento della malattia renale o la morte per causa cardiovascolare nelle persone con malattia renale.
    E.2.2Secondary objectives of the trial
    Secondary questions are whether taking empagliflozin pill once a day compared to an
    inactive pill (placebo) prevents:
    - hospitalization with heart failure or death from heart disease
    - death from any cause
    - hospitalization from any cause
    in people with kidney disease.
    Other questions include the safety and tolerability of empagliflozin compared to
    placebo.
    Domande secondarie sono se l'assunzione di una compressa di empagliflozin una volta
    al giorno rispetto a una compressa inattiva (placebo) previene:
    - il ricovero in ospedale per insufficienza cardiaca o di morte per causa cardiovascolare
    - la morte per qualsiasi causa
    - il ricovero ospedaliero per qualsiasi causa
    in pazienti con malattia renale.
    Altre domande riguardano la sicurezza e la tollerabilità di empagliflozin rispetto al
    placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age >=18 years at Screening.
    Evidence of progressive CKD at risk of kidney disease progression is defined on the
    basis of local laboratory results recorded at least 3 months before and at the time of
    the Screening visit, and requires that:
    (a) CKD-EPI eGFR >=20 <45 mL/min/1.73m²; or
    (b) CKD-EPI eGFR >=45 <90 mL/min/1.73m2 with urinary albumin:creatinine ratio >=200 mg/g
    (or protein:creatinine ratio >=300 mg/g)
    Note: the number of participants with or without diabetes mellitus (of any type) will be
    at least one-third of each, and the number of participants with an eGFR >45 mL/min/1.
    73m2 limited to about one-third. The Steering Committee will monitor these proportions
    and will limit recruitment of particular categories of participant in whom sufficient
    numbers have already been screened or randomized.
    Età >=18 anni alla visita di Screening
    Evidenza di malattia renale cronica (CKD) a rischio di progressione definita sulla base dei risultati di
    laboratorio locali effettuati almeno 3 mesi prima della visita di screening e al momento
    della visita di screening, e richiede che:
    a) CKD-EPI eGFR >=20 e <45 mL/min/1.73m²; o
    b) CKD-EPI eGFR >=45 e <90 mL/min/1.73m2 ed albuminuria (rapporto albumina /creatinina
    urinarie) >=200 mg/g o proteinuria (rapporto proteine/creatinina urinarie) >=300 mg/g
    Nota: almeno un terzo dei soggetti avrà diabete mellito e almeno un terzo sarà senza
    diabete mellito; non più di un terzo dei partecipanti avrà un eGFR>45 mL/min/1.73m2. Lo
    Steering Committee controllerà queste proporzioni e limiterà l’arruolamento delle
    categorie di pazienti per i quali sarà già stato screenato o randomizzato un numero
    sufficiente di soggetti
    E.4Principal exclusion criteria
    None of the following must be fulfilled:
    (i) Currently receiving SGLT-2 or SGLT-1/2 inhibitor;
    (ii) Diabetes mellitus type 2 and prior atherosclerotic cardiovascular disease with an
    eGFR >60 mL/min/1.73m2 at Screening;
    (iii) Receiving combined ACEi and ARB treatment;
    (iv) Maintenance dialysis, functioning kidney transplant, or scheduled living donor
    transplant;
    (v) Polycystic kidney disease;
    (vi) Previous or scheduled bariatric surgery;
    (vii) Ketoacidosis in the past 5 years;
    (viii) Symptomatic hypotension, or systolic blood pressure <90 or >180 mmHg at
    Screening;
    (ix) ALT or AST >3x ULN at Screening;
    (x) Hypersensitivity to empagliflozin or other SGLT-2 inhibitor;
    (xi) Any immunosuppression therapy in last 3 months; or anyone currently on >45 mg prednisolone (or equivalent);
    (xii) Use of an investigational medicinal product in the 30 days prior to
    Screening visit;
    (xiii) Known to be poorly compliant with clinic visits or prescribed medication;
    (xiv) Medical history that might limit the individual’s ability to take trial
    treatments for the duration of the study (e.g. severe respiratory disease; history of
    cancer or evidence of spread within last 4 years, other than non-melanoma skin cancer;
    or recent history of alcohol or substance misuse);
    (xv) Current pregnancy, lactation or women of childbearing potential (WOCBP), unless
    using highly-effective contraception.
    (xvi) Type I diabetes mellitus

    In addition, individuals will be excluded at the Randomization visit if the participant:
    (i) Does not adhere to Run-in treatment;
    (ii) Is no longer willing to be randomized and followed for at least 3 years;
    (iii) Is considered by a local investigator not to be suitable for randomization;
    or
    (iv) Experiences ketoacidosis, heart attack, stroke, or hospitalization for heart
    failure, or hospitalization for urinary tract infection or acute kidney injury during
    Run-in.
    Note that individuals who do not fulfil one or more inclusion criteria, or who fulfil
    one or more exclusion criteria, may be re-screened and later become eligible.
    (i) Paziente in trattamento con inibitore SGLT-2 o SGLT-1/2;
    (ii) Diabete mellito di tipo 2 e precedente malattia cardiovascolare aterosclerotica con
    eGFR> 60 mL/min/1.73m2 allo screening;
    (iii) Trattamento combinato con ACEi e ARB;
    (iv) Dialisi di mantenimento, paziente con rene trapiantato o con trapianto renale
    programmato;
    (v) Malattia renale policistica;
    (vi) Chirurgia bariatrica pregressa o programmata;
    (vii) Chetoacidosi negli ultimi 5 anni;
    (viii) Ipotensione sintomatica o pressione arteriosa sistolica <90 o > 180 mmHg
    allo screening;
    (ix) ALT o AST> 3x ULN allo screening;
    (x) Ipersensibilità a empagliflozin o ad altro inibitore SGLT-2;
    (xi) Terapia di immunosoppressione endovenosa negli ultimi 3 mesi; o trattamento in corso con > 45 mg di prednisolone (o equivalente);
    (xii) Uso di un farmaco sperimentale nei 30 giorni precedenti la visita di
    screening;
    (xiii) Scarsa compliance del paziente sia rispetto alle visite cliniche che alla
    terapia;
    (xiv) Condizioni che possono limitare la possibilità del paziente ad assumere il trattamento dello studio per tutta la durata dello Studio (ad es. malattia respiratoria
    grave; anamnesi di cancro o evidenza di metastasi negli ultimi 4 anni, diverse dal carcinoma cutaneo non melanoma; o storia recente di abuso di alcool o altre sostanze);
    (xv) Gravidanza, allattamento o donne in età fertile (WOCBP), a meno che non si utilizzi
    un metodo contraccettivo altamente efficace;
    (xvi) Diabete mellito di tipo 1.
    Inoltre alla visita di randomizzazione saranno esclusi i pazienti che:
    (i) Non saranno stati aderenti al trattamento nella fase di run-in;
    (ii) Non acconsentono più a essere randomizzati e seguiti per almeno 3 anni;
    (iii) Sono considerati non idonei da un Ricercatore locale; o
    (iv) Hanno avuto nella fase di run-in chetoacidosi, infarto, ictus o ricovero per
    scompenso cardiaco o ricovero per infezione del tratto urinario o danno renale acuto.
    Nota: i soggetti che non soddisfano uno o più criteri di inclusione, o che soddisfano
    uno o più criteri di esclusione, possono essere rivalutati in seguito e diventare
    eleggibili
    E.5 End points
    E.5.1Primary end point(s)
    Time to first occurrence of:
    • Kidney disease progression (end-stage kidney disease, a sustained declined in eGFR to <10 mL/min/1.
    73m², renal death, or a sustained decline >=40% in eGFR from randomization) or
    • Cardiovascular death
    Tempo al verificarsi del primo evento di:
    - progressione della malattia renale (malattia renale allo stadio finale, un declino prolungato di eGFR fino a <10 mL/min/1,73m², morte per causa renale, o un declino prolungato di eGFR >=40% rispetto al valore alla randomizzazione) o
    - Morte cardiovascolare
    E.5.1.1Timepoint(s) of evaluation of this end point
    After accrual of at least 1070 primary outcome events as defined in E5.1
    Dopo il raggiungimento di almeno 1070 eventi outcome primari come definiti in E5.1
    E.5.2Secondary end point(s)
    a) Time to first hospitalization for heart failure or cardiovascular death;
    b) Occurrences of all-cause hospitalizations (first and recurrent);
    c) Time to death from any cause.
    a) Tempo al primo ricovero per insufficienza cardiaca o morte cardiovascolare;
    b) occorrenze di ricoveri per tutti i motivi (primo ricovero e ricorrente);
    c) Tempo fino al decesso per qualsiasi causa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After accrual of at least 1070 primary outcome events as defined in E5.1
    Dopo il raggiungimento di almeno 1070 eventi outcome primari come definiti in E5.1
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 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 concerned24
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA95
    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
    Canada
    China
    Japan
    Malaysia
    United States
    Germany
    Italy
    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
    When the minimum number of required study outcomes has accrued, or the independent
    Data Monitoring Committee advises the trial should be stopped early, participants will be invited to Final Follow-up visits. This visit may occur earlier than their planned next 6-monthly visit. The end of the trial is then defined as the latest of the following two dates: 7 days after the last participant’s Final Follow-up visit, or the date of the last 4-week post-Final Follow-up blood draw.
    Quando sarà stato raggiunto il numero minimo di eventi richiesti, o se il DSMB dello studio ne consiglierà l'interruzione anticipata, i pazienti saranno invitati a fare la visita finale di follow-up. La visita può avvenire prima della prevista visita semestrale successiva. La fine della sperimentazione è definita come l'ultima delle due date seguenti: 7 giorni dopo la visita finale di follow-up dell'ultimo paziente, o la data dell'ultimo prelievo di sangue a 4 settimane dopo il follow-up finale.
    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.1.1.1In 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: 3500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2500
    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 state500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2500
    F.4.2.2In the whole clinical trial 6000
    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)
    Empagliflozin does not have a marketing authorization for chronic kidney disease, so at the conclusion of the study, submissions to health regulators will be made if the treatment is shown to be sufficiently safe and efficacious.
    Empagliflozin non ha un'autorizzazione all'immissione in commercio per le malattie renali croniche, pertanto, a conclusione dello studio, se il trattamento si dimostra sufficientemente sicuro ed efficace, sarà presentata una richiesta alle autorità sanitarie.
    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 Decision2020-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 06:08:07 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA