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    Summary
    EudraCT Number:2022-002453-25
    Sponsor's Protocol Code Number:MERCURI-2
    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:2023-02-14
    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 number2022-002453-25
    A.3Full title of the trial
    Preoperative sodium glucose cotransporter 2 inhibitors for prevention of postoperative acute kidney injury in cardiac surgery patients – a randomized, placebo-controlled, multi-centre, phase IV clinical trial
    Preoperatieve sodium glucose transporter-2 inhibitoren voor het voorkomen van postoperatief acuut nierfalen in hartchirurgie patiënten – een gerandomiseerde placebo-gecontroleerde, multi-center fase IV klinische studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the effects of sodium-glucose cotransporter 2 inhibitors on kidney function in patients undergoing cardiac surgery
    Studie naar effect van sodium-glucose cotransporter-2 inhibitoren op nierfunctie in patiënten die een hartoperatie ondergaan
    A.3.2Name or abbreviated title of the trial where available
    proMoting Effective Renoprotection in Cardiac sURgery patients by SGLT2- Inhibitors
    Bevorderen van nierbescherming in cardiochirurgische patiënten door middel van SGLT2 remmers
    A.4.1Sponsor's protocol code numberMERCURI-2
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05590143
    A.5.4Other Identifiers
    Name:CCMO ABRNumber:NL81190.018.22
    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 UMC
    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 supportNetherlands Organisation for Health Research and Development
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC
    B.5.2Functional name of contact pointCoordinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310205669111
    B.5.6E-maila.h.hulst@amsterdamumc.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 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.3.4Pharmaceutical 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
    D.3.9.1CAS number 461432-26-8
    D.3.9.4EV Substance CodeSUB31650
    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
    Cardiac Surgery-Associated Acute Kidney Injury
    cardiochirurgie geassocieerde nierinsufficiëntie
    E.1.1.1Medical condition in easily understood language
    Kidney failure following cardiac surgery
    Nierschade optredend na hartoperaties
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080266
    E.1.2Term Stage 1 acute kidney injury
    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 perioperative treatment with SGLT2 inhibitors reduces the incidence of cardiac surgery induced acute kidney injury.
    Om te onderzoeken of perioperatieve behandeling met SGLT2 inhibitoren de incidente van cardiochirurgie geassocieerd acuut nierfalen verminderd.
    E.2.2Secondary objectives of the trial
    Our primary secondary objective is a difference in Stage 3 AKI according to the KDIGO criteria.
    Secondly, we aim to study the efficacy of SGLT2 inhibitors in men and women separately.
    Furthermore, we intent to study the effect of the intervention on the following secondary outcomes:
    Postoperative renal function, length of stay in ICU and in-hospital stay, Major Adverse Kidney Events and Major Adverse Cardiovascular Events, quality of recovery, safety measures, health care costs, perioperative glucose control, hemodynamics and cardiac function.
    Ons primaire secundaire einddoel is een verschil in stadium 3 AKI volgens de KDIGO criteria.
    Ten tweede onderzoeken we de effectiviteit van SGLT2 inhibitoren op de primaire uitkomst in mannen en vrouwen apart.
    Verder willen we het effect van de interventie op de volgende secundaire uitkomsten onderzoeken:
    Postoperatieve nierfunctie, opname duur op de IC en in het ziekenhuis, Major Adverse Kidney Events and Major Adverse Cardiovascular Events, kwaliteit van herstel, veiligheidsuitkomsten, zorgkosten, perioperatieve glucose controle, hemodynamiek en cardiale functie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. > 18 years old
    2. Undergoing elective cardiac surgery.
    3. Providing informed consent
    1. > 18 jaar
    2. Electieve cardio-chirurgie.
    3. Afgegeven informed consent
    E.4Principal exclusion criteria
    1. Current treatment with SGLT2 inhibitors
    2. Reduced kidney function at baseline with eGFR < 20 ml/min at time of inclusion
    3. Diabetes Mellitus Type 1
    4. History of diabetic keto acidosis
    5. Diabetes Mellitus Type 2 with BMI<25 for people with type 2 diabetes who are using multiple daily insulin injections (both short and long-acting insulin)
    6. Systolic blood pressure < 100 mmHg at time of inclusion
    7. Emergency surgery, defined as in need of surgery for medical reasons < 7 days, i.e. “S1-4” according to the Amsterdam UMC classification
    8. Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
    9. Known or suspected allergy to trial products or other drugs in the same class
    1. Huidige behandeling met SGLT2 remmers
    2. Verminderde nierfunctie met eGFR<20 ml/min op moment van inclusie
    3. Type 1 Diabetes Mellitus
    4. Eerdere diabetische keto-acidose
    5. BMI<25 voor mensen met type 2 diabetes die meer dan eenmaaldaags insuline gebruiken
    6. Systolische bloeddruk <100 mmHg op moment van inclusie
    7. Spoedoperatie gedefinieerd als operatie genoodzaakt voor medische redenen binnen 7 dagen. ("S1-4" spoedclassificatie binnen het Amsterdam UMC)
    8. Potentieel vruchtbare vrouwen die mogelijks zwanger zijn, borstvoeding geven of van plan zijn zwanger te worden of geen voorbehoedsmiddelen gebruiken
    9. Bekende of vermoedde allergie voor een het studiemiddelen of voor een binnen dezelfde medicijnklasse
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of AKI within 7 days after surgery, satisfying KDIGO criteria
    Incidentie van AKI binnen 7 dagen postoperatief volgens KDIGO criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Creatinine will be measured daily until day 7 postoperatively or until discharge from hospital, urine output will be recorded as measured during routine medical care, until urinary catheter can be removed.
    Creatinine wordt dagelijks gemeten tot dag 7 postoperatief of tot ontslag uit het ziekenhuis, urineproductie wordt geregistreerd zoals gemeten tijdens routine medische zorg tot verwijderen van de urinekatheter.
    E.5.2Secondary end point(s)
    1. Stage 3 AKI according to KDIGO criteria.
    2. Postoperative maximum change of eGFR compared to the baseline eGFR.
    3. De novo postoperative atrial fibrillation, registered on a 12-lead ECG.
    4. LoS-ICU: Length of Stay in the Intensive Care Unit, measured in days.
    5. LoS-Hos: Length of Stay in Hospital, measured in days.
    6. MAKE: Major Adverse Kidney Events. Composite endpoint of death, new dialysis, and worsened renal function.1
    7. MACE: Major Adverse Cardiovascular Events. Composite endpoint of cardiovascular death, nonfatal myocardial infarction (MI), nonfatal ischaemic cerebral vascular accident (iCVA) and hospitalization for heart failure.
    8. Patient reported quality of recovery, according to the following three questionnaires:
    o DAH30: Days at Home in first 30 days2
    o WHO-DAS 2.0: World Health Organisation Disability Assessment Schedule 2.03
    o EQ5D5L: 5 level EuroQol 5D questionnaire: a standardised measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal 4
    9. Safety outcomes: genital mycotic infections, diabetic keto-acidosis, and hypoglycaemia, in addition to incidence of postoperative complications and Serious Adverse Events (SAEs).
    10. Healthcare costs and productivity costs will be objectified to weigh cost-effectiveness, using the following two questionnaires:
    o iPCQ: IMTA (Institute for Medical Technology Assessment) Productivity Cost Questionnaire.
    o IMCQ: IMTA (Institute for Medical Technology Assessment) Medical Consumption Questionnaire.
    11. Peri-operative glucose measurements (routinely measured in clinical setting): average daily glucose, incidence of hypoglycaemia (blood glucose < 4 mmol/l) and hyperglycaemia (blood glucose > 10 mmol/l)
    12. Peri-operative heamodynamic vital signs (routinely measured in clinical setting).
    13. Postoperative of cardiac function (echocardiography and cardiac biomarkers) routinely carried out in clinical practice.
    1. Stadium 3 AKI volgens de KDIGO criteria
    2. Postoperatieve verandering in eGFR ten opzichte van uitgangs eGFR
    3. De novo atriale fibrillatie, geregistreerd op een 12 afleidingen ECG
    4. Opnameduur IC
    5. Opnameduur ziekenhuis
    6. MAKE: Major Adverse Kidney Events. Gecombineerd eindpunt van overlijden, nieuwe dialyse en verminderde nierfunctie.
    7. MACE: Major Adverse Cardiovascular Events. Gecombineerd eindpunt van cardiovasculair overlijden, niet-fataal myocard infarct, niet-fatale ischemische beroerte en hospitalisatie voor hartfalen.
    8. Patiënt gerapporteerde kwaliteit van herstel, volgens de volgende enquetes:
    o DAH30: Days at Home in first 30 days2
    o WHO-DAS 2.0: World Health Organisation Disability Assessment Schedule 2.03
    o EQ5D5L: 5 level EuroQol 5D questionnaire4
    9. Veiligheidsuitkomsten: genitale schimmelinfecties, keto-acidose, hypoglycaemie, overage postoperatieve complicaties, en Serious Adverse Events (SAEs)
    10. Zorgkosten volgens de volgende 2 enquetes:
    o iPCQ: IMTA (Institute for Medical Technology Assessment) Productivity Cost Questionnaire.
    o IMCQ: IMTA (Institute for Medical Technology Assessment) Medical Consumption Questionnaire.
    11. Perioperatieve glucose controle: gemiddeld dagelijks glucose, incidentie van hypoglycaemie (glucose < 4 mmol/l) en hyperglycaemie (glucose > 10 mmol/l)
    12. Perioperatieve heamodynamiek.
    13. Postoperatieve cardiale functie (echocardiography and cardiale biomarkers).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,2,3. (Stage 3 AKI, eGFR and AF): measured daily until day 7 postoperatively or until discharge from hospital.
    4,5. (LoS): measured at time of discharge from ICU or Hospital
    6,7,8,9,10. (MAKE, MACE, QoR, safety, costs) Day 30 postoperatively.
    11. (Glucose): All glucose measurements performed during hospital admission and measured as part of routine perioperative care up to day 3 postoperatively (last day of intervention).
    12. (Heamodynamics): Average hourly heart rate and blood pressure during surgery from start of anaesthesia until discharge from the Intensive Care Unit.
    13. (Cardiac function): any postoperative cardiac biomarkers routinely measured and any postoperative echocardiography performed at routine postoperative follow-up up to day 30.
    1,2,3. (Stage 3 AKI, eGFR and AF): dagelijks gemeten tot dag 7 postoperatief of tot ziekenhuisontslag.
    4,5. (LoS): op moment van ontslag IC of ziekenhuis.
    6,7,8,9,10. (MAKE, MACE, QoR, safety, costs) dag 30 postoperatief.
    11. (Glucose): Alle glucose metingen tijdens ziekenhuis opname tot dag 3 postoperatief.
    12. (Heamodynamics): Per uur gemiddelde hartfrequentie en bloeddruk van start van anesthesie tot ontslag IC.
    13. (Cardiac function): Alle routine postoperatieve cardiale biomarkers gemeten en iedere postoperatieve echocardiografie tijdens routine opvolging tot 30 dagen na operatie.
    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 No
    E.6.5Efficacy No
    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) 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 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 concerned8
    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 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
    LVLS
    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 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: 392
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 392
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state784
    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 Decision2023-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-07
    P. End of Trial
    P.End of Trial StatusOngoing
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