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    Summary
    EudraCT Number:2017-002971-24
    Sponsor's Protocol Code Number:1245-0137
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-05-18
    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 ConcernedGermany - BfArM
    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
    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)
    A.3.2Name or abbreviated title of the trial where available
    EMPA-KIDNEY
    A.4.1Sponsor's protocol code number1245-0137
    A.5.4Other Identifiers
    Name:alternative numberingNumber:1245.137
    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 International GmbH
    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.3.4Pharmaceutical 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.3.9.4EV Substance CodeSUB35915
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Kidney Disease
    E.1.1.1Medical condition in easily understood language
    Long-standing problem with kidney function
    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 21.1
    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.
    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.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: EMPA-KIDNEY Body Composition Measurement Substudy
    Protocol: EMPA-KIDNEY Body composition measurement substudy justification and design V1.0 – 02-MAR-2019
    Objectives:
    The primary aim of this substudy is to use bioimpedance spectroscopy to assess, in a subset of EMPA-KIDNEY participants, the effect of empagliflozin 10 mg versus matching placebo on "Fluid Overload" at Randomisation, 2 month and 18 month Follow-up Visits.
    Secondary aims are to use bioimpedance spectroscopy to assess:
    1. Whether any effects of empagliflozin 10 mg versus matching placebo on "Fluid Overload" are modified by baseline factors, in particular by level of kidney function, glycosylated haemoglobin, body mass index, NT-proBNP, age, sex, RAS inhibitor use, and different diuretics
    2. The effects of empagliflozin 10 mg versus matching placebo early and later during follow-up on:
    - ECW
    - Intracellular water (ICW)
    - Adipose tissue mass indexed to weight (i.e. %)
    - Lean tissue mass indexed to weight (i.e. %)
    Exploratory aims are to:
    - Assess if changes in ECW, ICW, % adipose tissue mass, % lean tissue mass and "Fluid Overload" correlate with changes in blood pressure and relevant other biomarkers
    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 participants in whom sufficient numbers have already been screened or randomized.
    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 inhibitors;
    (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 1 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.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first occurrence of:
    • Kidney disease progression (end-stage kidney disease, a sustained eGFR <10 mL/min/1.73m², renal death, or a sustained ≥40% decline in eGFR from randomization) or
    • Cardiovascular death
    E.5.1.1Timepoint(s) of evaluation of this end point
    After accrual of at least 1070 primary outcome events as defined in E.5.1
    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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After accrual of at least 1070 primary outcome events as defined in E.5.1
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Canada
    China
    Germany
    Japan
    Malaysia
    Norway
    Sweden
    United Kingdom
    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
    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.
    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 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: 4200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1800
    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 state1250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2800
    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)
    See below.
    Nach Abschluss der Studie erfolgt eine Weiterführung der bestehenden leitliniengerechten Therapie. Die Therapieentscheidungen liegen in der Hand der behandelnden Fachärzte.
    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 Decision2018-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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