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    Summary
    EudraCT Number:2020-003285-40
    Sponsor's Protocol Code Number:2019PI117
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-20
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-003285-40
    A.3Full title of the trial
    Evaluation of the hemodynamic tolerance of potassium canrenoate in brain-dead organ donors: randomized controlled clinical trial "CANREO-PMO"
    Evaluation de la tolérance hémodynamique du canrénoate de potassium chez les donneurs d’organes en état de mort encéphalique : essai clinique randomisé contrôlé
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the hemodynamic tolerance of potassium canrenoate in brain-dead organ donors
    Evaluation de la tolérance hémodynamique du canrénoate de potassium chez les donneurs d’organes en état de mort encéphalique.
    A.3.2Name or abbreviated title of the trial where available
    CANREO-PMO
    CANREO-PMO
    A.4.1Sponsor's protocol code number2019PI117
    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 SponsorCHRU de Nancy
    B.1.3.4CountryFrance
    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 supportGIRCI Est
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Nancy
    B.5.2Functional name of contact pointDirector of Research and Innovation
    B.5.3 Address:
    B.5.3.1Street AddressBâtiment Recherche
    B.5.3.2Town/ cityVANDOEUVRE LES NANCY
    B.5.3.3Post code54000
    B.5.3.4CountryFrance
    B.5.4Telephone number+3383155285
    B.5.5Fax number+3383157451
    B.5.6E-maildripromoteur@chru-nancy.fr
    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 SOLUDACTONE 200 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER HOLDING FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameSoludactone 200mg
    D.3.4Pharmaceutical form Lyophilisate and solvent for solution for injection
    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 INNPOTASSIUM CANRENOATE
    D.3.9.1CAS number 2181-04-6
    D.3.9.4EV Substance CodeSUB09983MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM CHLORIDE SOLUTION 0.9%
    D.3.9.3Other descriptive nameSODIUM CHLORIDE SOLUTION 0.9%
    D.3.9.4EV Substance CodeSUB20079
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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
    hemodynamic of patients in a state of cerebral death candidate for renal or multiple organ removal (including kidney)
    Hémodynamique des sujets en mort encéphalique candidats à un prélèvement d’organe rénal ou multiple (dont rénal)
    E.1.1.1Medical condition in easily understood language
    Normal and pathological blood circulation in patients in a state of cerebral death candidate for renal or multiple organ removal (including kidney)
    circulation sanguine normale et pathologique d'un sujet en état de mort encéphalique (coma dépassé) candidat pour donner ses organes
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10058985
    E.1.2Term Organ donor
    E.1.2System Organ Class 10041244 - Social circumstances
    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 the impact of potassium canrenoate administration vs. placebo on the hemodynamics of brain-dead subjects who are candidates for kidney or multiple organ harvesting (including renal).
    Evaluer l’impact de l’administration de canrénoate de potassium vs. placebo sur l’hémodynamique des sujets en mort encéphalique candidats à un prélèvement d’organe rénal ou multiple (dont rénal).
    E.2.2Secondary objectives of the trial
    Assess the impact of potassium canrenoate administration vs. placebo in brain-dead donor on:
    1. the function of the graft at 3 months after transplantation in kidney recipients from these donors,
    2. the presence of dialysis or a glomerular filtration rate (GFR) estimated according to CKD-EPI <20mL / min / 1.73m2 at 3 months in kidney recipients from these donors,
    3. the survival of kidney recipients from these donors evaluated at 3 months,
    4. renal function, graft survival, and survival of kidney recipients from these donors evaluated at 1 year, 3 years and 10 years after transplantation.
    Evaluer l’impact de l’administration de canrénoate de potassium vs. placebo chez les donneurs en mort encéphalique sur :
    1. la fonction du greffon à 3 mois de la transplantation chez les receveurs de reins issus de ces donneurs,
    2. la présence de dialyse ou d’un débit de filtration glomérulaire (DFG) estimé selon CKD-EPI <20mL/min/1,73m2 à 3 mois chez les receveurs de reins issus de ces donneurs,
    3. la survie des receveurs de reins issus de ces donneurs évaluée à 3 mois,
    4. la fonction rénale, survie du greffon, et survie des receveurs de reins issus de ces donneurs évaluées à 1 an, 3 ans et 10 ans de la transplantation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men, women aged 18 years or older;
    • Encephalic death diagnosed either by 2 flat and areactive 30-minute electroencephalograms performed 4 hours apart or by a cerebral CT angiography showing a non-opacification of the cortical middle cerebral arteries and internal cerebral veins;
    • And from whom an harvesting of one or both kidneys is envisaged (within 6 hours or more), according to the procedures currently in force at the Agence de la Biomédecine;
    • Dose of vasopressor agent that have not varied by more than 1 mg/h in the hour preceding inclusion and dose of vasopressor pressure less than 7 mg / h at inclusion;
    • Euvolemic patient at inclusion;
    • Affiliated to Social Security scheme;
    • Signed written consent by the support person provided for in article L. 1111-6, or failing this by a family member.
    • Homme, femme âgé de 18 ans ou plus;
    • En état de mort encéphalique diagnostiquée soit par 2 électroencéphalogrammes plats et aréactifs de 30 minutes réalisées à 4 heures d’intervalle ou par une angioTDM cérébrale objectivant un arrêt total de la circulation intracrânienne;
    • Et chez qui un prélèvement d’un ou des deux reins est envisagé (dans les 6 heures ou plus), selon les procédures actuellement en vigueur à l’Agence de la Biomédecine;
    • Posologie d’amines vasopressives n’ayant pas varié de plus de 1mg/h dans l’heure précédant l’inclusion et dose d’amine vasopressive inférieure à 7 mg/h à l’inclusion;
    • Patient euvolémique à l’inclusion ;
    • Bénéficiant d’un régime d’affiliation à la Sécurité Sociale;
    • Signature du consentement par la personne de confiance prévue à l'article L. 1111-6, ou à défaut de celle-ci par un membre de la famille.
    E.4Principal exclusion criteria

    • Patient having received potassium canrenoate in the 48 hours preceding inclusion in the study;
    • Patient on long-term mineralocorticoid receptor antagonist (eplerenone or spironolactone);
    • Having a serum potassium concentration> 5.5 mmol / L on inclusion;
    • Contraindications to multi-organ removal (infectious, neoplastic causes, etc.);
    • Refusal of organ removal expressed by the patient (national register of refusals or reported by the family);
    • Probable inability to remove the kidneys: history of urine-renal disease, pre-existing chronic renal failure, morphological abnormalities of the kidneys, renal trauma;
    • Patients included in another interventional drug clinical trial;
    • Known potassium canrenoate and / or trometamol hypersensitivity;
    • Severe renal failure;
    • Severe atrioventricular conduction disorders;
    • Terminal stage of hepatocellular insufficiency;
    • Persons referred to in articles L. 1121-5, L.1121-6, L. 1121-7 and L1121-8 of France’s public health code:
    -Pregnant, parturient or lactating woman;
    -Persons deprived of their liberty by a judicial or administrative decision;
    -Minors (non emancipated);
    -Adults subject to legal protection measures (guardianship, curatorship, safeguard of justice);
    -Person undergoing psychiatric care under articles L3212-1 and L3213-1 of the Public Health Code.

    • Patient ayant reçu du canrénoate de potassium dans les 48h précédentes l’inclusion dans l’étude;
    • Patient sous antagoniste du récepteur minéralocorticoïde au long cours (éplérénone ou spironolactone);
    • Présentant une kaliémie > 5.5 mmol/L à l’inclusion;
    • Contre-indications au prélèvement multi-organes (causes infectieuses, néoplasiques,…);
    • Refus de prélèvement d'organe exprimé par le patient (registre national des refus ou rapporté par la famille);
    • Impossibilité probable à prélever les reins : antécédents uro-néphrologiques, insuffisance rénale chronique pré-existante, anomalies morphologiques des reins, traumatisme rénal;
    • Patients inclus dans un autre protocole interventionnel portant sur un médicament;
    • Hypersensibilité canrénoate de potassium et/ou trométamol connue ;
    • Insuffisance rénale sévère ;
    • Troubles graves de la conduction auriculoventriculaire ;
    • Stade terminal de l'insuffisance hépatocellulaire;
    • Personnes visées aux articles L. 1121-5, L.1121-6, L. 1121-7 et L1121-8 du code de la santé publique :
    -Femme enceinte, parturiente ou allaitante;
    -Personnes privée de liberté par une décision judiciaire ou administrative;
    -Personnes mineures (non émancipées);
    -Personne majeures faisant l’objet d’une mesure de protection légale (tutelle, curatelle, sauvegarde de justice);
    -Personne faisant l’objet de soins psychiatriques en vertu des articles L3212-1 et L3213-1 du code de la Santé Publique.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be a hierarchical composite of events, as described by Felker in 2010 (Circ HF - PMID 20841546) and used recently by our team in a trial in the context of resuscitation (Lévy, JACC, 2018 - PMID 29976291) including in descending order:
    A. death before organ removal,
    B. the inability to perform the renal swab (since the anticipated effectiveness of the canrenoate would mainly relate to this organ),
    C. the average hourly dose of noradrenaline / adrenaline between randomisation and departure to the operating room,
    D. the average hourly volume of crystalloids and / or colloids used between randomization and departure to the operating room.
    Le critère d’évaluation principal sera un composite hiérarchisé d’évènements, comme décrit par Felker en 2010 (Circ HF – PMID 20841546) et utilisé récemment par notre équipe dans un essai dans un contexte réanimatoire (Lévy, JACC, 2018 – PMID 29976291) comprenant par ordre décroissant :
    A. le décès avant réalisation du prélèvement d’organe,
    B. l’incapacité à réaliser le prélèvement rénal (puisque l’efficacité anticipée du canrénoate porterait principalement sur cet organe),
    C. la dose horaire moyenne de noradrénaline/adrénaline entre la randomisation et le départ au bloc opératoire,
    D. le volume horaire moyen de cristalloïdes et/ou colloïdes utilisé entre la randomisation et le départ au bloc opératoire.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be a hierarchical composite of events, as described by Felker in 2010 (Circ HF - PMID 20841546) and used recently by our team in a trial in the context of resuscitation (Lévy, JACC, 2018 - PMID 29976291) including in descending order:
    A. death before organ removal,
    B. the inability to perform the renal swab (since the anticipated effectiveness of the canrenoate would mainly relate to this organ),
    C. the average hourly dose of noradrenaline / adrenaline between randomisation and departure to the operating room,
    D. the average hourly volume of crystalloids and / or colloids used between randomization and departure to the operating room.
    Le critère d’évaluation principal sera un composite hiérarchisé d’évènements, comme décrit par Felker en 2010 (Circ HF – PMID 20841546) et utilisé récemment par notre équipe dans un essai dans un contexte réanimatoire (Lévy, JACC, 2018 – PMID 29976291) comprenant par ordre décroissant :
    A. le décès avant réalisation du prélèvement d’organe,
    B. l’incapacité à réaliser le prélèvement rénal (puisque l’efficacité anticipée du canrénoate porterait principalement sur cet organe),
    C. la dose horaire moyenne de noradrénaline/adrénaline entre la randomisation et le départ au bloc opératoire,
    D. le volume horaire moyen de cristalloïdes et/ou colloïdes utilisé entre la randomisation et le départ au bloc opératoire.
    E.5.2Secondary end point(s)
    Secondary objectifs will be evaluated by consulting data from the CRISTAL database :
    Objective 1 : the vital status and serum creatinine (in μmol / L) with estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2), 3 months after kidney transplant,
    Objective 2 : the percentage of patients dependent on dialysis and / or with an estimated GFR <20 mL / min / 1.73m² at 3 months,
    Objective 3 : the vital status of kidney recipients from these donors at 3 months
    Objective 4 : the vital status of kidney recipients from these donors and serum creatinine (in μmol / L) with estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2), 1 year, 3 years, and 10 years from transplant.
    Les objectifs secondaires seront évalués par la consultation des données de la base CRISTAL :

    Objectif 1 : le statut vital et la créatininémie (en μmol/L) avec estimation du débit de filtration glomérulaire (DFG) selon CKD-EPI (en mL/min/1.73m2), à 3 mois de la transplantation rénale,
    L’objectif 2 : le pourcentage de patients dépendant de la dialyse et/ou ayant un DFG estimé < 20 mL/min/1,73m² à 3 mois,
    L’objectif 3 : le statut vital des receveurs de reins issus de ces donneurs à 3 mois
    L’objectif 4 : le statut vital des receveurs de reins issus de ces donneurs et la créatininémie (en μmol/L) avec estimation du débit de filtration glomérulaire (DFG) selon CKD-EPI (en mL/min/1.73m2), à 1 an, 3 ans, et 10 ans de la transplantation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Objective 1 : the vital status and serum creatinine (in μmol / L) with estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2), 3 months after kidney transplant,
    Objective 2 : the percentage of patients dependent on dialysis and / or with an estimated GFR <20 mL / min / 1.73m² at 3 months,
    Objective 3 : the vital status of kidney recipients from these donors at 3 months
    Objective 4 : the vital status of kidney recipients from these donors and serum creatinine (in μmol / L) with estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2), 1 year, 3 years, and 10 years from transplant.
    Objectif 1 : le statut vital et la créatininémie (en μmol/L) avec estimation du débit de filtration glomérulaire (DFG) selon CKD-EPI (en mL/min/1.73m2), à 3 mois de la transplantation rénale,
    L’objectif 2 : le pourcentage de patients dépendant de la dialyse et/ou ayant un DFG estimé < 20 mL/min/1,73m² à 3 mois,
    L’objectif 3 : le statut vital des receveurs de reins issus de ces donneurs à 3 mois
    L’objectif 4 : le statut vital des receveurs de reins issus de ces donneurs et la créatininémie (en μmol/L) avec estimation du débit de filtration glomérulaire (DFG) selon CKD-EPI (en mL/min/1.73m2), à 1 an, 3 ans, et 10 ans de la transplantation.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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.8.5The 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
    the end of interventional study of the trial is the clamping aortic during the organ removal procedure of the last donor subject (duration of the trial: 30 months)
    Moreover a long term follow up of organ recipients patients and theirs grafts from study donors is schedule up to 10 years after the last transplant.
    La fin de l'étude interventionnelle de l'essai clinique correspond au clampage aortique du dernier patient donneur d'organe inclus dans l'étude (durée de l'essai clinique: 30 mois).
    De plus un suivi à long terme des patients receveurs et de leur greffons issue des donneurs de l'étude est prévu jusqu'à 10 ans après la dernière greffe .
    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 months30
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 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 2020-07-20. 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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Brain-dead organ donors. Signed written consent by the support person provided for in article L. 1111-6, or failing this by a family member.
    patients donneurs d'organes en état de mort encéphalique. Signature du consentement par la personne de confiance prévue à l'article L. 1111-6, ou à défaut de celle-ci par un membre de la famille.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    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
    Prise en charge usuelle dans le cadre du prélèvement d'organe.
    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 Decision2020-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
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