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    Summary
    EudraCT Number:2019-004670-25
    Sponsor's Protocol Code Number:CQ-001-19
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-004670-25
    A.3Full title of the trial
    Peritoneal Ultrafiltration in cardio Renal syndrome to prevent heart failure Exacerbation: The PURE Study
    Ultrafiltrazione Peritoneale per Sindrome Cardio Renale per Prevenire il Peggioramento dell’insufficienza Cardiaca: Lo studio PURE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Peritoneal Ultrafiltration in cardio Renal syndrome to prevent heart failure Exacerbation: The PURE Study
    Ultrafiltrazione Peritoneale per Sindrome Cardio Renale per Prevenire il Peggioramento dell’insufficienza Cardiaca: Lo studio PURE
    A.3.2Name or abbreviated title of the trial where available
    PURE
    PURE
    A.4.1Sponsor's protocol code numberCQ-001-19
    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 SponsorCorequest sagl
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCoreQuest Sagl
    B.5.2Functional name of contact pointCEO
    B.5.3 Address:
    B.5.3.1Street AddressVia Piave 110/7
    B.5.3.2Town/ cityPescara
    B.5.3.3Post code65122
    B.5.3.4CountryItaly
    B.5.6E-maila.arduini@corequest.ch
    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 No
    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 namePolyCore
    D.3.2Product code [N.A.]
    D.3.4Pharmaceutical form Solution for peritoneal dialysis
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 87-99-0
    D.3.9.2Current sponsor codeN.A.
    D.3.9.3Other descriptive nameD-Xilitol
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 541-15-1
    D.3.9.2Current sponsor codeN.A.
    D.3.9.3Other descriptive nameL-carnitine
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 337376-15-5
    D.3.9.2Current sponsor codeN.A.
    D.3.9.3Other descriptive nameIcodextrin, Polydextrin
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Congestive Heart Failure
    Insufficienza cardiaca congestizia
    E.1.1.1Medical condition in easily understood language
    Congestive Heart Failure
    Insufficienza cardiaca congestizia
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10007559
    E.1.2Term Cardiac failure congestive
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate if the treatment with PolyCore PUF has an impact on the composite endpoint of patient’s mortality or worsening of patient’s condition.
    L’obbiettivo primario è valutare se il trattamento con ultrafiltrazione peritoneale effettuata tramite soluzione PolyCore ha un impatto sull’endpont combinato di mortalità o peggioramento delle condizioni del paziente.
    E.2.2Secondary objectives of the trial
    1. the improvement of patients’ conditions
    2. the changes in the Quality of Life
    3. the decrease in the use of hospital resources
    4. the change in NYHA class
    5. the sparing or amelioration of the kidney function
    6. the patient urine output and urine sodium preservation
    7. the overall decrease of the sympathetic nerve tone
    8. the need of increasing of 30% the daily dose of loop diuretic
    9. the hospitalization for intra-venous therapy with loop diuretic
    10. safety
    1. miglioramento delle condizioni del paziente
    2. cambiamento della qualità della vita
    3. diminuzione dell'utilizzo di risorse ospedaliere
    4. cambiamento della classe NYHA
    5. risparmio o miglioramento della funzionalità renale
    6. l'output urinario del paziente e la preservazione del sodio
    7. il generale decremento del tono del nervo simpatico
    8. la necessità di aumentare del 30% la dose giornaliera di diuretici dell'ansa
    9. la necessità di ospedalizzazione per terapia intravenosa con diuretici dell'ansa
    10. Sicurezza
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age =18 years
    2. Left ventricular ejection fraction =60%
    3. NYHA Classification of III-IV despite guidelines directed medical therapy
    4. The persistency of right ventricular failure due to after load mismatch
    5. The cava vein enlargement (inner diameter, detected with focused echocardiography, between 1,5 and 2,5 cm, with respiratory collapse <50% or absent due to intravascular fluid overload)
    6. The decreased kidney function addressed by the measured GFR, defined as (urea clearance + creatinine clearance)/2 between 15 and 60 ml/min/1,73 m2
    7. NT pro-BNP plasma concentration > 1000 pg/ml or BNP plasma concentration > 250 pg/ml
    8. At least one episode of pulmonary or systemic congestion requiring high-dose intravenous diuretics (or diuretic combinations) in the 6 months before the study enrolment
    9. An appropriate PUF technique candidate.
    10. Signed informed consent form for participation in this study
    1. Età = 18 anni
    2. Frazione di eiezione del ventricolo sinistro =60%
    3. Classe NYHA di III-IV nonostante terapia medica standard
    4. Persistenza di insufficienza ventricolare destra dovuta ad un eccesso di post-carico (afterload mismatch)
    5. Allargamento della vena cava (diametro interno misurato tramite ecocardiografia mirata) tra 1,5 e 2,5 cm, con collasso respiratorio < 50% o assente dovuto ad accumulo di fluido intravascolare.
    6. Diminuita funzionalità renale valutata mediante GRF: definito come urea clearance misurata + creatinine clearance)/2 tra i 15 e 60 ml/min/1,73m2
    7. Concentrazione plasmatica di NT pro-BNP = 1000 pg/ml o concentrazione plasmatica di BNP > 250 pg/ml
    8. Almeno un episodio di congestione polmonare o sistemica richiedente una dose elevata di diuretico (o di combinazione di diuretici) nei sei mesi precedenti allo screening.
    9. Candidato appropriato per ultrafiltrazione peritoneale
    10. Modulo di consenso informato adeguatamente firmato
    E.4Principal exclusion criteria
    1. Recipients of heart transplantation
    2. Presence of a mechanical circulatory support device;
    3. Hypertrophic obstructive cardiomyopathy;
    4. Severe valvular stenosis;
    5. Acute coronary syndrome = 6 months before screening;
    6. Active myocarditis
    7. Cardiosurgical or Endoradiological heart procedures = 6 month before screening;
    8. Cardiac resynchronization therapy (CRT) implantation or upgrading of pacemaker PM or cardioverter defibrillator (ICD) to CRT = 6 months before screening;
    9. Patient with end-stage renal disease, with GFR, defined as (urea clearance + creatinine clearance)/2, <15 ml/min/1,73 m2GFR
    10. Any major organ transplant (liver, lung, kidney)
    11. Lung embolism = 6 months before screening;
    12. Fibrotic lung disease [clinically suspected and confirmed by high-resolution computed tomography (HRTC), if necessary];
    13. Liver cirrhosis (Child score B or C);
    14. Absolute contraindication to peritoneal catheter implantation;
    15. Logistical and or organizational contra-indication to treatment
    16. Active malignancy;
    17. Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later.
    18. Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception. *
    19. Unwilling or unable to give informed consent;
    20. Enrolment in another clinical trial involving medical or device based interventions.
    1. Destinatario di trapianto di cuore
    2. Portatore di device circolatorio meccanico
    3. Affetto da cardiomiopatia ipertrofica ostruttiva
    4. Affetto da stenosi valvolare severa
    5. Sindrome coronarica acuta avvenuta nei 6 mesi prima dello screening
    6. Miocardite attiva
    7. Avvenute procedure cardiochirurgiche endoradiologiche nei 6 mesi prima dello screening
    8. Impianto CRT o upgrade di PM o ICD a CRT avvenuto nei 6 mesi prima dello screening
    9. Affetto da malattia renale allo stadio terminale, con GFR, definito come (urea clearance + creatinine clearance)/2 < 15ml/ml*1.73/BSA
    10. Interessato da qualsiasi trapianto di organo maggiore (fegato, polmoni, rene)
    11. Avvenuta embolia polmonare nei 6 mesi prima dello screening
    12. Affetto da malattia polmonare fibrotica, clinicamente sospetta e confermata da tomografia ad alta risoluzione (HRTC) se necessario.
    13. Affetto da cirrosi (punteggio Child = B o C)
    14. Presenza di controindicazioni all’impianto del catetere peritoneale
    15. Controindicazioni logistiche o organizzative al trattamento
    16. Affetto da neoplasie attive
    17. Paziente di sesso femminile in gravidanza, o in allattamento, o che desidera rimanere incinta durante il periodo dello studio e per i tre mesi successivi
    18. Paziente di sesso femminile in età fertile (meno di 24 mesi dall’ultimo mestruale) che non utilizza metodi contraccettivi.
    19. Paziente incapace di prestare consenso informato
    20. Paziente reclutato in un altro studio clinico interventistico che prevede sia dispositive medici che prodotti medicinali
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter of the study is the composite endpoint of
    1 patient’s mortality - or
    2 hospitalization for cardiac causes, including the need for i.v. diuretics and/or hemofiltration - or
    3 the need of increasing of >=30% the initial daily dose of loop diuretic - or
    4 worsening renal function defined as eGRF <10 ml/min/1,73 m2
    Il parametro primario di efficacia dello studio è un endpoint combinato di:
    • Mortalità – oppure
    • Ospedalizzazione per cause cardiache, inclusa la necessità di terapia diuretica per infusione o emofiltrazione - oppure
    • Necessità di aumentare di >=30% la dose iniziale di diuretici dell’ansa – oppure
    • Peggioramento della funzionalità renale definito come eGFR < 10ml/min/1,73m2
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpoint is recorded at any time during the study.
    L'endpoint è rilevato durante l'intera durata di studio
    E.5.2Secondary end point(s)
    6 Requiring other methods of treatment [i.e. PUF or hemodialysis]; 1 6 minutes Walking distance; Quality of life tested with the Italian version of the Kansas City Cardiomyopathy Questionnaire (KCCQ) (76,77),; NT pro-BNP (N-terminal pro brain natriuretic peptide): i.e. the number of patients with a decrease in NT pro-BNT level of >=25% - or BNP (brain natriuretic peptide): i.e. the number of patients with a decrease in BNP level of >=40%; 4. Change in NYHA class from baseline; 5 Hospitalization for intra-venous therapy with loop diuretic; 7 Hospitalization for all causes; 8 Worsening of renal function, defined as the % of change of eGFR; 9 Change in the cumulative daily dosage of loop diuretic; 10 Need for additional types of diuretics (anti-aldosterone, metolazone, others) compared to baseline; 11 Use of hospital resources (the number of days spent in-hospital because of HF exacerbation; 12 The number of patients requiring hospitalization for intra-venous therapy with loop diuretic; 13 The number of patients increasing of =30% the initial daily dose of loop diuretic
    6. Necessità di altri metodi di trattamento [i.e. PUF o emodialisi]; 1. Distanza di cammino in sei minuti; Qualità della vita, misurata con la versione Italiana del questionario KCCQ (Kansas City Cardiomyopathy Questionnaire); 3NT pro-BNP (frammento ammino-terminale del pro-peptide di tipo B): definito come il numero di pazienti con un decremento delle concentrazioni del frammento >=25% - o BNP (peptide natriuretico di tipo B): definito come il numero di pazienti con un decremento delle concentrazioni del peptide >=40%; 4. Cambiamento della classe NYHA dalla baseline; 5. Ospedalizzazione per terapia diuretica intravenosa con diuretici dell’ansa; 7. Ospedalizzazione per qualsiasi causa; 8. Peggioramento della funzione renale, definito come la percentuale di cambiamento del GFR (eGFR e mGFR); 9. Modifica della dose giornaliera di diuretici dell’ansa; 10. Necessità di terapia addizionale di diuretici (anti-aldosterone, metolazone, etc.) rispetto alla baseline; 11. Utilizzo di risorse ospedaliere, definito come il numero di giorni passati in ospedale come conseguenza del peggioramento del quadro di insufficienza cardiaca; 12. Il numero di pazienti che richiedono ospedalizzazione per terapia diuretica intravenosa,; 13. Il numero di pazienti che aumentano di =30% la dose iniziale di diuretici dell’ansa
    E.5.2.1Timepoint(s) of evaluation of this end point
    At any time during the study; baseline, 3 and 6 months; at baseline and at 3 and 6 months; from baseline to 6 months; from baseline to 6 months; at any time during the study; At any time during the study; from baseline, at 3 and 6 months; over the 6 months of study treatment; At any time during the study; during the 6 months of study treatment; at any time during the study; at any time during the study
    In qualsiasi momento durante lo studio; baseline, a 3 e a 6 mesi; alla baseline e a 3 e 6 mesi.; dalla baseline a 3 e 6 mesi; dalla baseline a 6 mesi; In qualsiasi momento durante lo studio; In qualsiasi momento durante lo studio; dalla baseline a 3 e 6 mesi; durante i 6 mesi di trattamento; In qualsiasi momento durante lo studio; Durante i 6 mesi di trattamento; in qualsiasi momento durante studio; in qualsiasi momento durante lo studio.
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Adattivo
    Adaptive
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Il trattamento sperimentale + terapia standard (diuretici) confrontato con sola terapia standard
    Experimental treatment + standard therapy (diuretics) compared with standard therapy only
    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 concerned2
    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 Information not present in EudraCT
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state84
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 84
    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
    Nessuno
    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 Decision2022-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-16
    P. End of Trial
    P.End of Trial StatusOngoing
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