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    Summary
    EudraCT Number:2019-004152-10
    Sponsor's Protocol Code Number:EMPATHY
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 number2019-004152-10
    A.3Full title of the trial
    Evaluating the Short-Term Renal and Systemic Effects of SGLT2 Inhibition in Non-Diabetic Patients at Risk of Accelerated GFR Decline Because of Glomerular Hyperfiltration: a sequential OFF-ON-OFF Study with One-Month Empagliflozin Therapy Followed by One-Month Recovery Period
    Proposta di studio per valutare a breve termine gli effetti renali e sistemicidi Empagliflozin, un inibitore del co-trasportatore sodio-glucosio di tipo 2, in pazienti non diabetici iperfiltranti a rischio di un rapido declino della funzione renale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluating the Short-Term Renal and Systemic Effects of SGLT2 Inhibition in Non-Diabetic Patients at Risk of Accelerated GFR Decline Because of Glomerular Hyperfiltration: a sequential OFF-ON-OFF Study with One-Month Empagliflozin Therapy Followed by One-Month Recovery Period
    Proposta di studio per valutare a breve termine gli effetti renali e sistemici di Empagliflozin, un inibitore del co-trasportatore sodio-glucosio di tipo 2, in pazienti non diabetici iperfiltranti a rischio di un rapido declino della funzione renale
    A.3.2Name or abbreviated title of the trial where available
    SGLT2 inhibitors in glomerular hyperfiltration
    Inibitori SGLT2 nell'iperfiltrazione glomerulare
    A.4.1Sponsor's protocol code numberEMPATHY
    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 SponsorIRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBoehringer
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportIstituto di Ricerche Farmacologiche Mario Negri - IRCCS
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto di Ricerche Farmacologiche Mario Negri - IRCCS
    B.5.2Functional name of contact pointLaboratorio Attività Regolatorie pe
    B.5.3 Address:
    B.5.3.1Street Addressvia G.B. Camozzi, 3
    B.5.3.2Town/ cityRanica
    B.5.3.3Post code24020
    B.5.3.4CountryItaly
    B.5.4Telephone number0354535307
    B.5.5Fax number0354535371
    B.5.6E-mailpaola.boccardo@marionegri.it
    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 holderBoehriger Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameJardiance
    D.3.2Product code [JArdiance]
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obesity
    Renal chronic disease
    Obesità
    Insufficienza renale cronica
    E.1.1.1Medical condition in easily understood language
    Obesity
    Renal chronic disease
    Obesità
    Insufficienza renale cronica
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10009119
    E.1.2Term Chronic renal failure
    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
    To assess whether SGLT2 inhibition by empagliflozin 10 mg/day may induce an acute (and reversible) reduction in measured GFR (taken as a marker of amelioration of glomerular hyperfiltration).
    Valutare se l’inibizione del co-trasportatore SGLT2 con la somministrazione di empagliflozin 10 mg/die può determinare una riduzione acuta (e reversibile) del GFR misurato quale indice di miglioramento dell’iperfiltrazione glomerulare in pazienti con obesità patologica o malattia renale cronica con proteinuria residua significativa nonostante la terapia convenzionale.
    E.2.2Secondary objectives of the trial
    To assess whether empagliflozin treatment affects the following additional renal and systemic parameters:
    - 24 hour urinary output;
    - 24 hour urinary protein and albumin excretion;
    - 24 hour urinary urea, phosphate, sodium, glucose, potassium, uric acid and creatinine excretion;
    - Fractional clearance of total protein, albumin, sodium, potassium, uric acid, and free water;
    - Plasma and urine osmolality;
    - Body weight, body mass index and abdominal circumference;
    - Insulin sensitivity and glucose tolerance;
    - Office and 24 hour blood pressure and heart rate monitoring;
    - Pulse wave velocity (PWV) and other markers of vascular stiffness;
    - Circulating vasoactives hormones including atrial natriuretic peptide (ANP), the biologically inert NT-pro B-type natriuretic peptide (BNP), serum active renin, angiotensin II, aldosterone, vasopressin (ADH) and plasma concentration of high sensitive c reactive protein (hsCRP);
    Determinare se il trattamento con empagliflozin influenza i seguenti parametri renali e funzionali sistemici:
    - Diuresi giornaliera;
    - Escrezione urinaria delle 24 ore di proteine e albumina;
    - Escrezione urinaria delle 24 ore di urea, fosfato, sodio, potassio, acido urico e creatinina;
    - Clearance frazionata di albumina, sodio, potassio, acido urico e acqua libera;
    - Osmolarità plasmatica e delle urine;
    - Peso corporeo, indice di massa corporea (BMI) e circonferenza addominale;
    - Insulino-resistenza e tolleranza al glucosio;
    - Pressione arteriosa e frequenza cardiaca;
    - Velocità di propagazione dell'onda di polso e altri marker di rigidità vascolare;
    - Concentrazioni plasmatiche del peptide natriuretico atriale (ANP), del frammento amminoterminale del pro-peptide di tipo B (BNP), renina sierica attiva, angiotensina II, aldosterone, vasopressina (ADH) e proteina C reattiva ad alta sensibilità (hsCRP);
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female = 18 years old;
    - Increased risk of accelerated renal function loss because of absolute or relative hyperfiltration associated with unhealthy (abdominal) obesity or residual proteinuria defined as:
    Unhealthy obesity:
    - Waist circumference =94 cm in males and = 80 cm in females
    Metabolic syndrome, defined as the presence of at least three of the following criteria:
    - Blood pressure>140/90 mmHg or controlled blood pressure under current antihypertensive treatment
    - Triglyceride levels >150 mg/dL
    - HDL<40 mg/dL in males <50 mg/dL in females
    - Fasting blood glucose > 100 mg/dL
    Residual proteinuria:
    - Urinary protein excretion >1g/24-h to <3g/24-h despite stable and continuous RAS inhibitor therapy with ACE inhibitors or ARBs for at least three months Blood pressure in recommended targets and stable treatment with blood pressure lowering medications for at least three months
    - Female childbearing potential and non-sterile male must agree to use a method of contraception according to 2014 CTFG Recommendations related to contraception and pregnancy testing in clinical trials;
    - Written informed consent.
    - Donne e uomini di età = 18 anni;
    - Aumentato rischio di perdita accelerata della funzione renale a causa di iperfiltrazione assoluta o relativa associata ad obesità patologica o proteinuria residua definite come:
    Obesità patologica:
    Circonferenza della vita =94 cm negli uomini e = 80 cm nelle donne
    Sindrome metabolica, definita come presenza di almeno tre dei seguenti criteri:
    - Pressione >140/90 mmHg o pressione controllata in presenza di terapia antipertensiva;
    - Livelli di trigliceridi >150 mg/dL
    - HDL<40 mg/dL negli uomini; <50 mg/dL nelle donne;
    - Glicemia a digiuno> 100 e <125 mg/dL
    Proteinuria residua:
    - Escrezione urinaria di proteine > 1g/24-h e < 3g/24-hnonostante la presenza di una terapia stabile e continuativa con inibitori del RAS (ACE inibitori o ARB) da almeno tre mesi;
    - Pressione entro i valori target e terapia stabile con farmaci antipertensivi per almeno tre mesi;
    - Donne potenzialmente fertili e maschi non sterili che accettino di utilizzare metodi contraccettivi altamente efficaci in accordo con il documento del CTFG del 2014 “Raccomandazioni relative alla contraccezione e ai test di gravidanza negli studi clinici;
    - Consenso informato scritto.
    E.4Principal exclusion criteria
    Exclusion Criteria
    1. Type 1or 2 diabetic patients;
    2. Fasting blood glucose > 125 mg/dl and/or concomitant treatment with insulin or oral hypoglycemic agents;
    3. Estimated GFR = 60 ml/min/1.73m2 (CKD-EPI formula);
    4. Reversible causes of transient increases of proteinuria including infection, fever, strenuous physical exercise
    5. Nephrotic syndrome of any etiology;
    6. Patients with Autosomal Dominant Polycystic Kidney Disease;
    7. Symptomatic urinary tract lithiasis or obstruction;
    8. Ischemic kidney disease (because of possible excess risk of acute kidney injury upon SGLT2 inhibition associated reduction in sodium pool and kidney perfusion pressure);
    9. Rapidly progressive kidney disease defined by impairment of renal function within 2 weeks – 3 months (for the cohort of patients with residual proteinuria only) ;
    10. Active systemic autoimmune diseases;
    11. Treatment for glomerulopathies or systemic diseases with steroids or any other immunosuppressive agent within one year;
    12. Hypersensitivity to the active principle (empagliflozin) or any of the excipients (e.g. lactose);;
    13. Heart failure with or without decreased systolic function;
    14. Uncontrolled hypertension or symptomatic hypotension;
    15. History of malignancy within 5 years of screening;
    16. Inability to fully understand the possible risks and benefits related to study participation;
    17. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 90 days after last dose; or intending to donate ova during such time period;
    18. If male, the subject intends to donate sperm while on the study this study or for 90 days after last dose;
    19. Alcohol and drug abuse;
    20. Participation in another interventional clinical trial within the 4 weeks prior to screening.
    - Diabete di tipo 1 o 2;
    - Glicemia a digiuno >125 mg/dL e/o trattamenti concomitanti con insulina o agenti ipoglicemizzanti orali;
    - GFR simato = 60ml/min/1.73m2 (CKD-EPI formula);
    - Aumento transitorio della proteinuria dovuto a cause reversibili quali febbre, infezioni, strenuo esercizio fisico;
    - Sindrome nefrosica di qualsiasi origine;
    - Pazienti con ADPKD;
    - Litiasi o ostruzione sintomatiche del tratto urinario;
    - Malattia ischemica del rene (in quanto la riduzione nella riserva di sodio e della pressione di perfusione del rene legata all’inibizione di SGLT2 potrebbe determinare un rischio eccessivo di danno renale acuto);
    - Malattia renale rapidamente progressiva solo per la coorte di pazienti con proteinuria residua definita come peggioramento della funzione renale durante le 2 settimane-3 mesi precedenti lo studio;
    - Malattie autoimmuni sistemiche in fase attiva;
    - Trattamenti concomitanti con steroidi o altri agenti immunosoppressivi per glomerulopatie o malattie sistemiche nell’ultimo anno;
    - Ipersensibilità al principio attivo principale (empaglifozin) o ad uno degli eccipienti (ad esempio lattosio); Insufficienza cardiaca con o senza diminuzione della funzione sistolica;
    - Ipertensione non controllata o ipotensione sintomatica;
    - Tumori maligni nei 5 anni precedenti lo screening;
    - Incapacità di comprendere appieno i possibili rischi e i benefici legati alla partecipazione allo studio;
    - Per pazienti di sesso femminile: se il soggetto è in stato interessante, sta allattando o desidera restare incinta durante o entro i 90 giorni successivi alla fine dello studio, oppure intende donare, durante questo periodo, gli ovociti;
    - Per pazienti di sesso maschile: se il soggetto intende donare lo sperma durante lo studio o nei 90 giorni successivi alla fine dello studio;
    - Abuso di alcool o di droghe;
    - Partecipazione a qualsiasi altro studio interventistico entro le 4 settimane precedenti lo screening.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in GFR measured by the iohexol plasma clearance technique from baseline to the end of one-month treatment period
    Variazioni del GFR misurato con la tecnica della clearance plasmatica dello ioexolo al basale e alla fine del periodo di trattamento e di recovery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Basal, at the end of the treatment period and at the end of the recovery period.
    Basale, alla fine del periodo di trattamento e alla fine del periodo di recovery.
    E.5.2Secondary end point(s)
    - 24 hour urinary output;
    - 24 hour urinary protein and albumin excretion;
    - 24 hour urinary urea, phosphate, sodium, glucose, potassium, uric acid and creatinine excretion;
    - Fractional clearance of total protein, albumin, sodium, potassium, uric acid, and free water;
    - Plasma and urine osmolality;
    - Body weight, body mass index and abdominal circumference;
    - Insulin sensitivity and glucose tolerance;
    - Office and 24 hour blood pressure and heart rate monitoring;
    - Pulse wave velocity (PWV) and other markers of vascular stiffness;
    - Circulating vasoactives hormones including atrial natriuretic peptide (ANP), the biologically inert NT-pro B-type natriuretic peptide (BNP), serum active renin, angiotensin II, aldosterone, vasopressin (ADH) and plasma concentration of high sensitive c reactive protein (hsCRP);
    Moreover, the following outcomes will be assessed:
    - Need for diuretic therapy and blood pressure, glucose, and lipid lowering medications;
    - Patient health-related SF36 Quality of Life.
    - Diuresi delle 24 ore (l’ultima di tre raccolte successive);
    - Escrezione urinaria nelle 24 ore di proteine e albumina (mediana delle misurazioni su tre raccolte urinarie consecutive delle 24 ore);
    - Escrezione nelle 24 ore di urea, fosfato, sodio, potassio, acido urico e creatinina (valutate nell’ultima di tre raccolte successive);
    - Clearance frazionata delle proteine totali, albumina, sodio, potassio, acido urico e acqua libera, calcolate con le formule standard;
    - Osmolarità del plasma e delle urine calcolate con le formule standard;
    - Peso corporeo, indice di massa corporea (BMI) e circonferenza addominale;
    - Tasso di smaltimento del glucosio dal sanguemisurato con il clamp iperinsulinemico euglicemico e tolleranza al glucosio misurata con il test da carico di glucosio e l’indice di HOMA (Homeostasis Model Assessment);
    - Pressione arteriosa e frequenza cardiaca in ambulatorio (media di tre misurazioni successive a distanza di due minuti una dall’altra eseguite in posizione seduta) e monitoraggio nelle 24 ore (giorno e notte) degli stessi parametri;
    - Velocità di propagazione dell'onda di polso e altri marker di rigidità vascolare misurati con la tonometria;
    - Concentrazioni plasmatiche di peptide natriuretico atriale (ANP), frammento amminoterminale del pro-peptide di tipo B (BNP), renina sierica attiva, angiotensina II, aldosterone, vasopressina (ADH) e proteina C reattiva ad alta sensibilità (hsCRP);
    - Necessità di terapia diuretica e con farmaci che controllano la pressione arteriosa, la glicemia e/o i lipidi;
    - Valutazione della Qualità della vita del paziente attraverso la somministrazione di questionari validati.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Basal, at the end of the treatment period and at the end of the recovery period.; Basale, alla fine del periodo di trattamento e alla fine del periodo di recovery.
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Disegno OFF/ON/OFF
    OFF/ON/OFF design
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 44
    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)
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    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 Decision2020-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-09-03
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