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    The EU Clinical Trials Register currently displays   41449   clinical trials with a EudraCT protocol, of which   6808   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-000165-16
    Sponsor's Protocol Code Number:DC2019REGROUP01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-000165-16
    A.3Full title of the trial
    A single-center, prospective, placebo-controlled, double-blind, randomized, cross-over mechanistic intervention study to investigate the effect of empagliflozin on kidney function in people with either preserved or impaired kidney function with or without type 2 diabetes
    Een single-center, prospectieve, placebo-gecontroleerde, dubbelblinde, gerandomiseerde, cross-over mechanistische interventiestudie om het effect van empagliflozine op de nierfunctie te onderzoeken bij mensen met een behouden of verminderde nierfunctie met of zonder type 2 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Renohemodynamic Effects empaGliflozin in vaRiOUs Populations
    Renohemodynamische effecten van empaGliflozine in verschillende populaties
    A.3.2Name or abbreviated title of the trial where available
    REGROUP
    A.4.1Sponsor's protocol code numberDC2019REGROUP01
    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 SponsorAmsterdam University Medical Center - location VU Medical Center
    B.1.3.4CountryNetherlands
    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 Ingelheim
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam University Medical Center - location VU Medical Center
    B.5.2Functional name of contact pointDaniel van Raalte
    B.5.3 Address:
    B.5.3.1Street AddressBoelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.6E-maild.vanraalte@vumc.nl
    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.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameEmpagliflozine
    D.3.2Product code A10BK03
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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
    Diabetes Mellitus type 2
    Diabetes type 2
    E.1.1.1Medical condition in easily understood language
    Diabetes type 2
    Suikerziekte
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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
    Investigate the effects of 7 days of therapy with the SGLT2 inhibitor empagliflozin (10 mg QD) versus placebo on measured glomerular filtration rate (mGFR)) in metformin and/or sulfonyl (SU) treated T2DM patients with normal kidney function, metformin, SU and/or insulin-treated T2DM patients with impaired kidney function and hypertensive people without T2DM with impaired kidney function, all treated with RAS blockers.
    Onderzoek de effecten van 7 dagen therapie met de SGLT2-remmer empagliflozine (10 mg QD) versus placebo op gemeten glomerulaire filtratiesnelheid (mGFR)) in metformine en / of sulfonyl (SU) behandelde T2DM-patiënten met normale nierfunctie, metformine, SU en / of met insuline behandelde T2DM-patiënten met nierfunctiestoornis en hypertensieve mensen zonder T2DM met nierfunctiestoornis, alle behandeld met RAS-blokkers.
    E.2.2Secondary objectives of the trial
    To assess the effects of 7 days treatment with SGLT2 inhibitor empagliflozin (10 mg QD) versus placebo in metformin and/or SU-treated T2DM patients with normal kidney function, metformin, SU and/or insulin-treated T2DM patients with impaired kidney function and hypertensive people without T2DM with impaired kidney function on:
    1) Renal hemodynamics including effective renal plasma flow (ERPF) and renal vascular resistance (RVR)
    2) Systemic hemodynamics (mean arterial pressure (MAP) & heart rate)
    3) Caffeine-induced changes in renal hemodynamics including GFR, ERPF and RVR
    4) Empagliflozin-induced proximal sodium excretion by using fractional excretion of lithium as a surrogate of proximal sodium handling.
    Om de effecten van 7 dagen behandeling met SGLT2-remmer empagliflozine (10 mg QD) versus placebo te beoordelen bij metformine en / of SU-behandelde T2DM-patiënten met normale nierfunctie, metformine, SU en / of insuline-behandelde T2DM-patiënten met verminderde nierfunctie en hypertensieve mensen zonder T2DM met verminderde nierfunctie op:
    1) Renale hemodynamiek inclusief effectieve renale plasmastroom (ERPF) en niervasculaire weerstand (RVR)
    2) Systemische hemodynamica (gemiddelde arteriële druk (MAP) & hartslag)
    3) Door cafeïne veroorzaakte veranderingen in de hemodynamiek van de nier, waaronder GFR, ERPF en RVR
    4) Empagliflozine-geïnduceerde proximale natriumuitscheiding door fractionele uitscheiding van lithium te gebruiken als surrogaat van proximale natriumbehandeling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Caucasian*
    • Both genders (females must be post-menopausal; no menses >1 year; in case of doubt, Follicle-Stimulating Hormone (FSH) will be determined with cut-off defined as >31 U/L)
    • Age: 45 - 80 years
    • BMI: >25 kg/m2
    • For with people with diabetes - a diagnosis of T2DM with glycosylated haemoglobin (HbA1c) ≥6.5% (≥48 mmol/mol) and <10.5% (<91 mmol/mol); and eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 or >75 mL/min/1.73m2 at the Screening Visit (Visit 1).
    • In the normoglycemic, hypertensive, individuals: HbA1c <6.5% (<48 mmol/mol) and an eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 at the Screening Visit (Visit 1).
    • In the diabetic arm: people with an eGFR >75 ml/min/1.73m2 should be treated with a stable dose of metformin and/or SU, people with an eGFR between ≥25 and ≤50 mL/min/1.73m2 should be treated with a stable dose of metformin, SU and/or insulin therapy for at least 3 months prior to inclusion
    • Patient specific antihypertensive dose of an angiotensin receptor blocker (ARB) (as per Investigator’s judgement) for at least 4 weeks prior to Visit 2 (Day 3).
    • Written informed consent
    - Kaukasische *
    • Beide geslachten (vrouwen moeten postmenopauzaal zijn; geen menstruatie> 1 jaar; in geval van twijfel zal het follikelstimulerend hormoon (FSH) worden bepaald met een cut-off gedefinieerd als> 31 U / L)
    • Leeftijd: 45 - 80 jaar
    • BMI:> 25 kg / m2
    • Voor mensen met diabetes - een diagnose van T2DM met geglycosyleerd hemoglobine (HbA1c) ≥6,5% (≥48 mmol / mol) en <10,5% (<91 mmol / mol); en eGFR (CKD-EPI) tussen ≥25 en ≤50 ml / min / 1,73 m2 of> 75 ml / min / 1,73 m2 bij het screeningsbezoek (bezoek 1).
    • Bij de normoglycemische, hypertensieve personen: HbA1c <6,5% (<48 mmol / mol) en een eGFR (CKD-EPI) tussen ≥25 en ≤50 ml / min / 1,73 m2 bij het screeningsbezoek (bezoek 1).
    • In de diabetische arm: mensen met een eGFR> 75 ml / min / 1,73 m2 moeten worden behandeld met een stabiele dosis metformine en / of SU, mensen met een eGFR tussen ≥25 en ≤50 ml / min / 1,73 m2 moeten behandeld met een stabiele dosis metformine, SU en / of insulinetherapie gedurende ten minste 3 maanden voorafgaand aan opname
    • Patiënt specifieke anti-hypertensieve dosis van een angiotensinereceptorblokker (volgens het oordeel van de onderzoeker) gedurende ten minste 4 weken voorafgaand aan bezoek 2 (dag 3).
    • Schriftelijke geïnformeerde toestemming
    E.4Principal exclusion criteria
    History of unstable or rapidly progressing renal disease
    • Diagnosis of polycystic kidney disease.
    • Post renal transplant
    • History of or current lupus nephritis.
    • Abnormal vital signs, after 10 minutes supine rest, definas as any of the following (Visit 1):
    o Systolic blood pressure above 180 mmHg
    o Diastolic blood pressure above 110 mmHg
    • Current/chronic use of the following medication: SGLT2 inhibitors,TZD, GLP-1RA, DPP-4 inhibitors, , antimicrobial agents or chemotherapeutics.
    • Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
    • Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e. sports injury, head-ache or back ache). However, no such drug can be taken within a time-frame of 2 weeks prior to renal-testing
    • History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalization) within 1 month prior to the Screening visit.
    • Current urinary tract infection and active nephritis
    • Recent (<3 months) history of cardiovascular disease, including:
    o Acute coronary syndrome
    o Chronic heart failure (New York Heart Association grade II-IV)
    o Stroke or transient ischemic neurologic disorder
    • Complaints compatible with neurogenic bladder and/or incomplete bladder emptying (as determined by ultrasonic bladder scan)
    • Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
    • History of or actual malignancy (except basal cell carcinoma)
    • History of or actual severe mental disease
    • Substance abuse (alcohol: defined as >4 units/day)
    • Allergy to any of the agents used in the study
    Geschiedenis van instabiele of snel voortschrijdende nierziekte
    • Diagnose van polycystische nierziekte.
    • Post-niertransplantatie
    • Geschiedenis van of huidige lupus nefritis.
    • Abnormale vitale functies, na 10 minuten rugligging, gedefinieerd als een van de volgende (bezoek 1):
    o Systolische bloeddruk boven 180 mmHg
    o Diastolische bloeddruk boven 110 mmHg
    • Huidig ​​/ chronisch gebruik van de volgende medicatie: SGLT2-remmers, TZD, GLP-1RA, DPP-4-remmers, antimicrobiële middelen of chemotherapeutica.
    • Patiënten zonder volume. Patiënten met een risico op volumedepletie als gevolg van gelijktijdig bestaande aandoeningen of gelijktijdig toegediende medicijnen, zoals lisdiuretica, moeten zorgvuldige monitoring van hun volumestatus hebben.
    • Chronisch gebruik van niet-steroïde ontstekingsremmende geneesmiddelen (NSAID's) is niet toegestaan, tenzij gebruikt als incidentele medicatie (1-2 tabletten) voor niet-chronische indicaties (d.w.z. sportletsel, hoofdpijn of rugpijn). Een dergelijk medicijn kan echter niet binnen een tijdsbestek van 2 weken voorafgaand aan niertesten worden ingenomen
    • Geschiedenis van diabetische ketoacidose (DKA) die medische interventie (bijv. Spoedbezoek en / of ziekenhuisopname) vereist binnen 1 maand voorafgaand aan het screeningsbezoek.
    • Huidige urineweginfectie en actieve nefritis
    • Recente (<3 maanden) geschiedenis van hart- en vaatziekten, waaronder:
    o acuut coronair syndroom
    o Chronisch hartfalen (New York Heart Association graad II-IV)
    o Beroerte of voorbijgaande ischemische neurologische aandoening
    • Klachten die compatibel zijn met neurogene blaas en / of onvolledige lediging van de blaas (zoals bepaald door ultrasone blaasscan)
    • Ernstige leverinsufficiëntie en / of significante abnormale leverfunctie gedefinieerd als aspartaat aminotransferase (AST)> 3x bovenlimiet van normaal (ULN) en / of alanine aminotransferase (ALT)> 3x ULN
    • Geschiedenis van of werkelijke maligniteit (behalve basaalcelcarcinoom)
    • Geschiedenis van of werkelijke ernstige psychische aandoeningen
    • Misbruik van middelen (alcohol: gedefinieerd als> 4 eenheden / dag)
    • Allergie voor een van de in het onderzoek gebruikte middelen
    E.5 End points
    E.5.1Primary end point(s)
    Investigate the effects of 7 days of therapy with the SGLT2 inhibitor empagliflozin (10 mg QD) versus placebo on measured glomerular filtration rate (mGFR)) in metformin and/or sulfonyl (SU) treated T2DM patients with normal kidney function, metformin, SU and/or insulin-treated T2DM patients with impaired kidney function and hypertensive people without T2DM with impaired kidney function, all treated with RAS blockers.
    Onderzoek de effecten van 7 dagen therapie met de SGLT2-remmer empagliflozine (10 mg QD) versus placebo op gemeten glomerulaire filtratiesnelheid (mGFR)) in metformine en / of sulfonyl (SU) behandelde T2DM-patiënten met normale nierfunctie, metformine, SU en / of met insuline behandelde T2DM-patiënten met nierfunctiestoornis en hypertensieve mensen zonder T2DM met nierfunctiestoornis, alle behandeld met RAS-blokkers.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 7 days
    na 7 dagen
    E.5.2Secondary end point(s)
    To investigate the effects of 7 days of therapy with SGLT-2 inhibitor empagliflozin (10 mg QD) versus placebo on:
    • Other renal hemodynamics:
    o Effective Renal Plasma Flow (ERPF)
    o Renal Vascular Resistance (RVR)
    • Systemic hemodynamics, measured as:
    o Mean Arterial Pressure (MAP)
    • Caffeine-induced changes in renal and systemic hemodynamics: GFR, ERPF, RVR and MAP
    • Empagliflozin-induced proximal sodium excretion.
    o Fractional excretion of lithium will be used as a surrogate to measure proximal tubular sodium handling, wheres fractional excretion of sodium assesses total overall (proximal and distal (tubular sodium handling).
    Om de effecten van 7 dagen therapie met SGLT-2-remmer empagliflozine (10 mg QD) versus placebo te onderzoeken op:
    • Andere renale hemodynamiek:
    o Effectieve nierplasmastroom (ERPF)
    o Niervasculaire weerstand (RVR)
    • Systemische hemodynamiek, gemeten als:
    o gemiddelde arteriële druk (MAP)
    • Door cafeïne veroorzaakte veranderingen in nier- en systemische hemodynamica: GFR, ERPF, RVR en MAP
    • Empagliflozine-geïnduceerde proximale natriumuitscheiding.
    o Fractionele excretie van lithium zal worden gebruikt als een surrogaat om de proximale tubulaire natriumbehandeling te meten, waarbij fractionele excretie van natrium de totale totale (proximale en distale (tubulaire natriumbehandeling) bepaalt
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 days
    7 dagen
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    mechanistic
    mechanistisch
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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 months
    E.8.9.1In the Member State concerned days
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state72
    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
    geen
    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 Decision2020-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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