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    Summary
    EudraCT Number:2014-003589-25
    Sponsor's Protocol Code Number:Levo-AKI
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-03
    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 ConcernedSweden - MPA
    A.2EudraCT number2014-003589-25
    A.3Full title of the trial
    The effect of levosimendan, on renal blood flow, function and oxygen uptake during acute renal failure after cardiac surgery
    Effekten av levosimendan, en hjärtstimulerande medicin, på njurens blodflöde, funktion samt syrgasupptag vid akut njursvikt efter hjärtkirurgi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison between levosimendan and placebo in acute renal failure after cardiac surgery
    Jämförelse mellan levosimendan och placebo vid akut njursvikt efter hjärtkirurgi
    A.3.2Name or abbreviated title of the trial where available
    Levo-AKI
    Levo-AKI
    A.4.1Sponsor's protocol code numberLevo-AKI
    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 SponsorSahlgrenska Universitetssjukhuset/Sahlgrenska
    B.1.3.4CountrySweden
    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 supportSahlgrenska Academy
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska Universitetssjukhuset/Sahlgrenska
    B.5.2Functional name of contact pointTIVA
    B.5.3 Address:
    B.5.3.1Street AddressBlå Stråket 5
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post code412 45
    B.5.3.4CountrySweden
    B.5.4Telephone number46(0)31342 10 00 7798
    B.5.5Fax number46(0)3141 38 62
    B.5.6E-mailraija.saikkonen@vgregion.se
    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 Simdax
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Pharma
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameSimdax
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOSIMENDAN
    D.3.9.1CAS number 141505-33-1
    D.3.9.4EV Substance CodeSUB08493MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg/h milligram(s)/kilogram/hour
    D.3.10.2Concentration typerange
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute kidney injury postoperatively in connection with heart surgery
    Akut njursvikt i samband med hjärtkirurgi
    E.1.1.1Medical condition in easily understood language
    Acute renal failure
    Akut njursvikt
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    To investigate the effects of levosimendan vs. placebo on the kidney glomerular filtration rate (GFR).
    Att undersöka effekten av levosimendan vs placebo på njurens glomerulära filtrationen (GFR). Primär end-point är förändring i GFR (ml/min) mätt med infusionsclearance av Cr-EDTA.
    E.2.2Secondary objectives of the trial
    Renal blood flow (RBF), renal vascular resistance (RVR), filtration fraction (GFR / RBF), diuresis, renal sodium excretion, cardiac output (CO), mean arterial pressure (MAP), heart rate, central venous pressure (CVP).
    Renalt blodflöde (RBF), renal vaskulär resistans (RVR), filtrationsfraktion (GFR/RBF), diures, renal natriumutsöndring, cardiac output (CO), medelartärtryck (MAP), hjärtfrekvens och centralt ventryck (CVP).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patient to undergo a planned heart surgery with heart-lung machine
    -Patient must have normal renal function preoperatively, s-creatinine <110 umol/L
    -Age > 18 years
    -Patient must have developed acute renal failure, defined as serum creatinine increase> 50% or 27 mmol / L
    -Patient and/or family members must be in favor of participating in the investigation
    1. Patienten skall genomgå ett planerat hjärtkirurgiskt ingrepp med hjärtlungmaskin
    2. Patienten skall ha normal njurfunktion preoperativt, s-kreatinin < 110 umol/L
    3. Patienten skall vara över 18 år
    4. Patienten skall ha utvecklat akut njursvikt definierad som s-kreatininstegring > 50% eller 27 mmol/L
    5. Patienten och/eller anhöriga skall vara positiva till inklusion
    E.4Principal exclusion criteria
    -Ongoing treatment with inotropes such as milrinone, levosimendan, dopamine or dobutamine (norepinephrine does not count as inotropic drugs)
    -Second central venous saturation <60% despite optimization of volume status and hematocrit
    -Pregnant women in the first trimester due 51 Cr-EDTA (radiolabeled)
    -Pregnant women due lack of documentation of levosimendan
    1. Pågående behandling med inotropa läkemedel såsom milrinon, levosimendan, dopamin eller dobutamin. Noradrenalin räknas ej som inotropt läkemedel
    2. Centralvenös mättnad <60% trots optimering av volymsstatus och hematokrit
    3. Gravida kvinnor i första trimestern p.g.a. 51 Cr-EDTA (radioaktivt märkt)
    4. Gravida kvinnor p.g.a. avsaknad av dokumentation av levosimendan
    E.5 End points
    E.5.1Primary end point(s)
    Change in GFR (mL/min) measured by infusion clearance of Cr-EDTA.
    Förändring i GFR (ml/min) mätt med infusionsclearance av Cr-EDTA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    70 minutes after infusion of levosimendan
    70 minuter efter infusion av levosimendan
    E.5.2Secondary end point(s)
    Renal blood flow (RBF), renal vascular resistance (RVR), filtration fraction (GFR / RBF), diuresis, renal sodium excretion, cardiac output (CO), mean arterial pressure (MAP), heart rate, central venous pressure (CVP).
    Renalt blodflöde (RBF), renal vaskulär resistans (RVR), filtrationsfraktion (GFR/RBF), diures, renal natriumutsöndring, cardiac output (CO), medelartärtryck (MAP), hjärtfrekvens och centralt ventryck (CVP).
    E.5.2.1Timepoint(s) of evaluation of this end point
    70 minutes after infusion of levosimendan
    70 minuter efter infusion av levosimendan
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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 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 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
    The study will be terminated after follow-up of last patient is completed
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-09-03. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A few patents will be sedated, intubated and mechanically ventilated at inklusion. In these cases the relatives to be informed and consulted.
    Ett fåtal patenter kommer att vara sederade, intuberade och mekaniskt ventilerade vid inklusionstillfället. I dessa fall kommer anhörig att informeras och tillfrågas.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    Patients will be observed at the clinic during and after the infusion to ensure no severe allergic reaction or adverse reactions will occurs.
    Emergency medical treatment will be constantly available. The patient will be in the hospital the day before surgery, on TIVA 1-2 days postoperatively and thereafter 4-6 days on the ward. Careful monitoring of possible side effects will be identified and addressed.
    Patienterna observeras på kliniken under och efter infusionerna för att se att ingen svårare allergisk reaktion eller biverkning inträffar. Medicinsk akutbehandling finnas hela tiden tillgänglig. Patienten kommer att befinna sig på sjukhuset dagen före operationen, på TIVA postoperativt 1-2 dygn och därefter ytterligare 4-6 dagar på vårdavdelning. Noggrann övervakning av eventuella biverkningar kan därför upptäckas och åtgärdas.
    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 Decision2014-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-01
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