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    Summary
    EudraCT Number:2018-004651-20
    Sponsor's Protocol Code Number:402-C-1808
    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:2021-01-05
    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 number2018-004651-20
    A.3Full title of the trial
    A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease
    Studio di efficacia e sicurezza di fase III di Bardoxolone metile in pazienti con malattia policistica renale autosomica dominante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease
    Studio di efficacia e sicurezza di fase III di Bardoxolone metile in pazienti con malattia policistica renale autosomica dominante
    A.3.2Name or abbreviated title of the trial where available
    FALCON
    FALCON
    A.4.1Sponsor's protocol code number402-C-1808
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03918447
    A.5.4Other Identifiers
    Name:US IND NUMBERNumber:140817
    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 SponsorREATA PHARMACEUTICALS, INC.
    B.1.3.4CountryUnited States
    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 supportREATA PHARMACEUTICALS, INC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReata Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Program Operations
    B.5.3 Address:
    B.5.3.1Street Address2801 Gateway Drive, Suite 150
    B.5.3.2Town/ cityIrving, Texas
    B.5.3.3Post code75063
    B.5.3.4CountryUnited States
    B.5.6E-mailFALCON_402C1808@reatapharma.com
    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 nameBardoxolone methyl 5 mg
    D.3.2Product code [RTA 402]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNBardoxolone Metile
    D.3.9.1CAS number 218600-53-4
    D.3.9.2Current sponsor codeRTA 402
    D.3.9.3Other descriptive nameBardoxolone methyl
    D.3.9.4EV Substance CodeSUB33044
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 nameBardoxolone methyl 10 mg
    D.3.2Product code [RTA 402]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNbardoxolone methyl
    D.3.9.1CAS number 218600-53-4
    D.3.9.2Current sponsor codeRTA 402
    D.3.9.3Other descriptive namebardoxolone methyl
    D.3.9.4EV Substance CodeSUB33044
    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 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.IMP: 3
    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 nameBardoxolone methyl 20 mg
    D.3.2Product code [RTA 402]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNBardoxolone methyl
    D.3.9.1CAS number 218600-53-4
    D.3.9.2Current sponsor codeRTA 402
    D.3.9.3Other descriptive nameBardoxolone methyl
    D.3.9.4EV Substance CodeSUB33044
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 4
    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 nameBardoxolone methyl 15 mg
    D.3.2Product code [RTA 402]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNBardoxolone Methyl
    D.3.9.1CAS number 218600-53-4
    D.3.9.2Current sponsor codeRTA 402
    D.3.9.3Other descriptive nameBardoxolone methyl
    D.3.9.4EV Substance CodeSUB33044
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Autosomal dominant polycystic kidney disease
    malattia renale policistica autosomica dominante
    E.1.1.1Medical condition in easily understood language
    Autosomal dominant polycystic kidney disease
    malattia renale policistica autosomica dominante
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036046
    E.1.2Term Polycystic kidney, autosomal dominant
    E.1.2System Organ Class 100000004850
    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 change from baseline in estimated glomerular filtration rate (eGFR) at Week 52 following a 4-week drug treatment withdrawal period.
    To assess safety and tolerability.
    Valutare la variazione rispetto al basale della velocità di filtrazione glomerulare stimata (eGFR) alla Settimana 52 dopo un periodo di sospensione del trattamento farmacologico della durata di 4 settimane.
    Valutare la sicurezza e la tollerabilità.
    E.2.2Secondary objectives of the trial
    To assess the change from baseline in eGFR at Week 104 following a 4-week drug treatment withdrawal period.
    To assess the change from baseline in eGFR after 48 weeks of treatment.
    To assess the change from baseline in eGFR after 100 weeks of treatment.
    Valutare la variazione rispetto al basale dell’eGFR alla Settimana 104 dopo un periodo di sospensione del trattamento farmacologico della durata di 4 settimane.
    Valutare la variazione rispetto al basale dell’eGFR dopo 48 settimane di trattamento.
    Valutare la variazione rispetto al basale dell’eGFR dopo 100 settimane di trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients 18 = age = 70 upon study consent;
    2. Diagnosis of ADPKD by modified Pei-Ravine criteria: 1) at least 3 cysts per kidney by sonography or at least 5 cysts by CT or MRI with family history of ADPKD or 2) at least 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history;
    3. Screening eGFR (average of Screen A and Screen B eGFR values) = 30 to = 90 mL/min/1.73 m2 (18 to 55 years) or = 30 to = 44 mL/min/1.73 m2 (56 to 70 years):
    a. Patients with either screening eGFR = 60 to = 90 mL/min/1.73 m2 or age 56 to 70 years, must have evidence of ADPKD progression (i.e., eGFR decline of = 2.0 mL/min/1.73 m2 per year, based on historical eGFR data and medical monitor discretion);
    b. The two eGFR values collected at Screen A and Screen B visits used to determine eligibility must have a percent difference = 25%;
    4. Albumin to creatinine ratio (ACR) = 2500 mg/g at Screen B visit;
    5. Systolic blood pressure = 140 mmHg and diastolic blood pressure = 80 mmHg at Screen A visit after a period of rest. Patients receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) must be on a stable dose for at least 6 weeks prior to the Screen A visit;
    6. Adequate bone marrow reserve and organ function at the Screen A visit as follows:
    a. Hematologic: Absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin (Hgb) = 9 g/dL;
    b. Hepatic: Total bilirubin (TBL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) = the upper limit of normal (ULN);
    7. Able to swallow capsules;
    8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
    9. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures.
    1. Pazienti di sesso maschile e femminile di età compresa tra 18 anni compiuti e 70 anni compiuti, previo consenso allo studio;
    2. Diagnosi di ADPKD definita in base ai criteri Pei-Ravine modificati: 1) almeno 3 cisti per rene rilevate mediante sonografia o almeno 5 cisti rilevate mediante TC o RMI con anamnesi familiare di ADPKD o 2) almeno 10 cisti per rene rilevate mediante qualsiasi tecnica radiologica ed esclusione di altre malattie renali cistiche in assenza di anamnesi familiare positiva;
    3. Valore eGFR allo screening (media dei valori eGFR allo Screening A e allo Screening B) compreso nell’intervallo = 30 e = 90 mL/min/1,73 m2 (18 - 55 anni) o nell’intervallo = 30 e = 44 mL/min/1,73 m2 (56 - 70 anni):
    a. I pazienti con eGFR allo screening nell’intervallo tra = 60 e = 90 mL/min/1,73 m2 o età compresa tra 56 e 70 anni devono presentare evidenze di progressione di ADPKD (ad es. riduzione dell’eGFR = 2,0 mL/min/1,73 m2 su base annua, valutata rispetto ai dati storici di eGFR e a discrezione del monitor medico);
    b. I due valori di eGFR raccolti alle visite di Screening A e di Screening B utilizzate per stabilire l’eleggibilità dei pazienti devono avere una differenza percentuale = 25%;
    4. Rapporto albumina-creatinina (ACR) = 2500 mg/g alla visita di Screening B; 5. Pressione arteriosa sistolica = 140 mmHg e pressione arteriosa diastolica = 80 mmHg alla visita di Screening A dopo un periodo di riposo. I pazienti trattati con un inibitore dell’enzima di conversione dell’angiotensina (ACE) e/o un bloccante del recettore dell’angiotensina II (ARB) devono essere in trattamento con una dose stabile da almeno 6 settimane prima della visita di Screening A;
    6. Adeguata riserva midollare e funzionalità d’organo alla visita di Screening A, in relazione a quanto segue:
    a. Valori ematologici: Conta neutrofili assoluta > 1,5 x 109/L, piastrine > 100 x 109/L, emoglobina (Hgb) = 9 g/dL;
    b. Valori epatici: Bilirubina totale (TBL), alanina aminotransferasi (ALT) e aspartato aminotransferasi (AST) = limite superiore della norma (ULN);
    7. Paziente in grado di deglutire le capsule;
    8. Paziente disposto e in grado di rispettare le visite programmate, il programma terapeutico, i test di laboratorio e le altre procedure dello studio;
    9. Evidenza di un documento di consenso informato firmato e datato personalmente dal paziente, attestante che il paziente è stato informato in merito a tutti gli aspetti pertinenti lo studio prima dell’avvio di qualsiasi procedura richiesta dal protocollo.
    E.4Principal exclusion criteria
    1. Prior exposure to bardoxolone methyl;
    2. Concomitant use of tolvaptan is excluded. Patients previously treated with tolvaptan must have discontinued drug for at least 3 months prior to Screen A visit and had no history of elevations of ALT or AST > ULN while they were receiving tolvaptan. Initiation of concomitant tolvaptan use during the study is not permitted;
    3. History of administration of polycystic kidney disease-modifying agents (somatostatin analogues) within 3 months prior to the Screen A visit;
    4. B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit;
    5. Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit;
    6. Serum albumin < 3 g/dL at Screen A visit;
    7. History of intracranial aneurysms;
    8. Kidney or any other solid organ transplant recipient or a planned transplant during the study;
    9. Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening;
    10. History of clinically significant left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:
    a. Clinically significant congenital or acquired valvular disease;
    b. Left ventricular ejection fraction < 40% (based on echocardiogram performed at Screen A visit or within 6 months prior to Day 1);
    c. Pericardial constriction (based on echocardiogram performed at Screen A visit or within 6 months prior to Day 1);
    d. Restrictive or congestive cardiomyopathy (based on echocardiogram performed at Screen A visit or within 6 months prior to Day 1);
    e. Symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or angina);
    f. History of hospitalization for heart failure;
    g. Cardiac insufficiency, defined as New York Heart Association Class III or IV;
    h. History of untreated atrial fibrillation;
    i. History of unstable arrhythmias;
    11. Systolic BP < 90 mm Hg at Screen A visit after a period of rest;
    12. BMI < 18.5 kg/m2 at the Screen A visit;
    13. History of malignancy within 5 years prior to Screen A visit, with the exception of localized skin or cervical carcinomas;
    14. Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study;
    15. Untreated or uncontrolled active bacterial, fungal, or viral infection;
    16. Participation in other interventional clinical studies within 30 days prior to Day 1;
    17. Unwilling to practice acceptable methods of birth control (both males who have partners of child-bearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested;
    18. Women who are pregnant or breastfeeding;
    19. Known hypersensitivity to any component of the study drug;
    20. Any abnormal laboratory level that, in the opinion of the investigator, would put the patient at risk by trial enrollment;
    21. Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
    1. Precedente esposizione al bardoxolone metile;
    2. L’uso concomitante di Tolvaptan non è consentito. I pazienti precedentemente trattati con tolvaptan devono aver interrotto il farmaco almeno 3 mesi prima della visita di Screening A e la loro anamnesi non deve segnalare aumenti dei valori ALT o AST > ULN durante il trattamento con tolvaptan. Non è ammesso l’inizio di un trattamento concomitante con tolvaptan nel corso dello studio;
    3. Somministrazione di agenti modificanti la malattia renale policistica (analoghi della somatostatina) entro 3 mesi dalla visita di Screening A.
    4. Livello del peptide natriuretico di tipo B (BNP) > 200 pg/mL alla visita di Screening A;
    5. Diabete non controllato (HbA1c > 11,0%) alla visita di Screening A;
    6. Albumina sierica < 3 g/dL alla visita di Screening A;
    7. Anamnesi di aneurismi intracranici;
    8. Trapianto di rene o di altro organo solido oppure trapianto programmato durante lo studio;
    9. Dialisi acuta o lesione renale acuta entro 12 settimane dalla visita di Screening A o durante lo Screening;
    10. Anamnesi di cardiopatia del lato sinistro clinicamente significativa e/o cardiopatia clinicamente significativa, tra cui, a titolo esemplificativo ma non esaustivo:
    a. Valvulopatia congenita o acquisita clinicamente significativa:
    b. Frazione di eiezione ventricolare sinistra < 40% (basata su ecocardiogramma eseguito alla visita di Screening A o entro 6 mesi prima del Giorno 1);
    c. Costrizione pericardica (basata su ecocardiogramma eseguito alla visita di Screening A o entro 6 mesi prima del Giorno 1);
    d. Cardiomiopatia restrittiva o congestizia (basata su ecocardiogramma eseguito alla visita di Screening A o entro 6 mesi prima del Giorno 1);
    e. Malattia coronarica sintomatica (precedente infarto del miocardio, intervento coronarico percutaneo, bypass aorto-coronarico o angina);
    f. Anamnesi di ospedalizzazione per insufficienza cardiaca;
    g. Insufficienza cardiaca di classe III o IV secondo la New York Heart Association;
    h. Anamnesi di fibrillazione atriale non trattata;
    i. Anamnesi di aritmie instabili;
    11. PA sistolica < 90 mmHg alla visita di Screening A dopo un periodo di riposo;
    12. BMI < 18,5 kg/m2 alla visita di Screening A;
    13. Anamnesi di tumore maligno entro 5 anni dalla visita di Screening A, eccetto carcinomi localizzati della cute o della cervice;
    14. Immunosoppressione sistemica della durata cumulativa superiore a 2 settimane entro le 12 settimane prima della randomizzazione o previsione della necessità di un’immunosoppressione durante lo studio;
    15. Infezione batterica, fungina o virale attiva, non trattata o non controllata
    16. Partecipazione ad altri studi clinici interventistici entro 30 giorni prima del Giorno 1;
    17. Paziente riluttante a utilizzare metodi contraccettivi accettabili (sia pazienti di sesso maschile con partner in età potenzialmente fertile che pazienti di sesso femminile in età potenzialmente fertile) durante lo Screening, durante il trattamento con il farmaco di studio e per un periodo di almeno 30 giorni dall’assunzione dell’ultima dose del farmaco di studio;
    18. Donne in gravidanza o allattamento;
    19. Nota ipersensibilità ad uno qualsiasi dei componenti del farmaco di studio;
    20. Eventuali valori di laboratorio anomali che, a discrezione dello sperimentatore, metterebbero a rischio il paziente a causa dell’arruolamento nello studio;
    21. Il paziente è incapace, a discrezione dello sperimentatore, di adempiere ai requisiti del protocollo dello studio oppure non è eleggibile per lo studio per qualsiasi motivo.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    Change from baseline in eGFR at Week 52 (following a 4-week drug treatment withdrawal period).
    Safety and Tolerability:
    Frequency, intensity, and relationship to study drug of AEs and SAEs,and change from baseline in the following assessments: vital sign measurements, 12-lead ECGs, clinical laboratory measurements, and weight.
    Efficacia:
    cambiamento dell’eGFR rispetto al basale alla settimana 52 (e dopo un periodo di sospensione del trattamento farmacologico della durata di 4 settimane).

    Sicurezza e tollerabilità:
    Frequenza, intensità, e correlazione di AEs e SAEs con il farmaco in studio e cambiamento rispetto al basale dei seguenti parametri: segni vitali, ECG, valori di laboratorio e peso
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint will be analyzed after all patients have completed their Week 52 visit.
    The primary safety endpoint will be assessed throughout the clinical trial.
    L'end point primario di efficacia sarà analizzato quando tutti i pazienti avranno completato la visita della settimana 52.
    L'end point primario di sicurezza sarà valutato per tutta la durata dello Studio
    E.5.2Secondary end point(s)
    Change from baseline in eGFR at Week 104 (following a 4-week drug treatment withdrawal period).
    Change from baseline in eGFR at week 48
    Change from baseline in eGFR at week 100
    cambiamento dell’eGFR rispetto al basale alla settimana 104 (dopo un periodo di sospensione del trattamento farmacologico della durata di 4 settimane).
    cambiamento dell’eGFR rispetto al basale alla settimana 48
    cambiamento dell’eGFR rispetto al basale alla settimana 100
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be scheduled to be assessed during treatment at Weeks 1,2, 4, 6, 8, 12, 24, 36, 48, 52(A), 52(B), 64, 76, 88, 100, 104(A) and 104(B).
    I pazienti saranno valutati durante il trattamento alle settimane 1,2, 4, 6, 8, 12, 24, 36, 48, 52(A), 52(B), 64, 76, 88, 100, 104(A) and 104(B).
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    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 No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    United States
    Belgium
    Czechia
    France
    Germany
    Italy
    Spain
    United Kingdom
    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 years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 300
    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)
    After completion of the study subjects will not receive any further study-specific treatment. They will be provided with standard medical care treatment
    Dopo la conclusione dello Studio i soggetti non riceveranno nessun ulteriore trattamento studio specifico. Saranno trattati con terapie standard
    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 Decision2019-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-20
    P. End of Trial
    P.End of Trial StatusOngoing
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