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    Summary
    EudraCT Number:2014-003818-92
    Sponsor's Protocol Code Number:CURITIBA_TRIAL
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-31
    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 number2014-003818-92
    A.3Full title of the trial
    CUstodiol vs RInger: whaT Is the Best Agent?

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison between Ringer and Custodiol in renal perfusion during thoracoabdominal aortic surgery
    A.3.2Name or abbreviated title of the trial where available
    CURITIBA TRIAL
    A.4.1Sponsor's protocol code numberCURITIBA_TRIAL
    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 SponsorOspedale San Raffaele, UO Chirurgia Vascolare
    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 supportDr. Franz-Kohler Chemie GmbH, Bensheim
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele
    B.5.2Functional name of contact pointUO Chirurgia Vascolare
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina 60
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number00390226437377
    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 Custodiol
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Franz-Kohler Chemie GmbH, Bensheim, Germany
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCustodiol
    D.3.4Pharmaceutical form Solution for organ preservation
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial 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 Yes
    D.3.11.13.1Other medicinal product typeKidney Protector
    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
    Thoracoabdominal aortic aneurysm
    E.1.1.1Medical condition in easily understood language
    AORTA EXPANSION AT THE CHEST AND ABDOMEN
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10002882
    E.1.2Term Aortic aneurysm
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ASSESSING THE EFFECTIVENESS OF RENAL PERFUSION WITH CUSTODIOL IN REDUCING THE RENAL DAMAGE AFTER SURGICAL
    E.2.2Secondary objectives of the trial
    ASSESSING VALIDITY 'BIOMARKER OF SERUM AND URINE FROM KIDNEY DAMAGE SUB-CLINICAL AND CLINICAL POST-ISCHEMIC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Age ≥ 18 years
    2 Ability to provide written informed consent
    3 Patient underwent surgery for thoraco-abdominal aortic aneurysmectomy with need for renal perfusion
    E.4Principal exclusion criteria
    1 Patients who have participated in a drug trial in the previous three months
    2 Intervention under emergency / urgency
    3 Patient uncooperative and / or mental changes
    4 Referred allergy or intolerance to the study drug
    5. Any contraindication shown on the Summary of Product Characteristics (SPC) of the study drugs
    Patient 6 in renal replacement treatment (dialysis) at the time of
    7 Women who are pregnant or breast-feeding
    E.5 End points
    E.5.1Primary end point(s)
    Make a significant reduction of acute renal failure (AKI - Defined according to the diagram 2013.9 KDIGO see Table 1) in postoperative surgical patients who receive renal perfusion with respect to Custodiol those who receive standard perfusion with Ringer's lactate solution
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 DAYS
    E.5.2Secondary end point(s)
    • perioperative trend (from the preoperative to the sixth postoperative day) of the estimated glomerular filtration rate (eGFR) calculated on a daily basis using the formula Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 10 between the two groups of renal perfusion
    • identify independent predictors of postoperative acute renal failure
    • length of stay in the Intensive Care Unit (ICU)
    • in-hospital length of stay
    • In-hospital mortality, 28-day and one year after surgery.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • perioperative trend (from the preoperative to the sixth postoperative day) of the estimated glomerular filtration rate (eGFR) calculated on a daily basis using the formula Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 10 between the two groups of renal perfusion
    • identify independent predictors of postoperative acute renal failure (28 days)
    • length of stay in the Intensive Care Unit (ICU) (60 days)
    • in-hospital length of stay (60 days)
    • In-hospital mortality, 28-day and one year after surgery.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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 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) Yes
    E.8.2.2Placebo No
    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
    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 months0
    E.8.9.1In the Member State concerned 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state90
    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)
    follow-up clinical and instrumental routinely expected for this type of patients
    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 Decision2014-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-17
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