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    Summary
    EudraCT Number:2014-000226-38
    Sponsor's Protocol Code Number:156-13-210
    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:2014-08-05
    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 number2014-000226-38
    A.3Full title of the trial
    A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,
    Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,
    Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early
    Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
    Studio di fase 3b, multicentrico, randomizzato di sospensione, controllato con placebo, in doppio cieco a gruppi paralleli, per confrontare l’efficacia e la sicurezza di Tolvaptan (da 45 a 120 mg/giorno in dose separata) in soggetti affetti da malattia renale cronica compresa fra una fase 2 avanzata e una fase 4 iniziale dovuta a rene policistico autosomico dominante.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease
    questo è uno studio per valutare la sicurezza e l’efficacia di Tolvaptan in soggetti adulti con malattia renale cronica.
    A.4.1Sponsor's protocol code number156-13-210
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02160145
    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 SponsorOtsuka Pharmaceutical Development & Commercialization, 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 supportOtsuka Pharmaceutical Development & Commercialization, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.5.2Functional name of contact pointOlga Sergeyeva, MD, MPH
    B.5.3 Address:
    B.5.3.1Street Address2440 Research Boulevard
    B.5.3.2Town/ cityRockville,
    B.5.3.3Post codeMaryland 20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number1-609-249-6643
    B.5.5Fax number1-609-249-0643
    B.5.6E-mailolga.sergeyeva@otsuka-us.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1175
    D.3 Description of the IMP
    D.3.1Product nameTolvaptan 15mg
    D.3.4Pharmaceutical form Tablet
    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 INNTolvaptan
    D.3.9.2Current sponsor codeOPC-41061
    D.3.9.4EV Substance CodeSUB31691
    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 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.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1175
    D.3 Description of the IMP
    D.3.1Product nameTolvaptan 30mg
    D.3.4Pharmaceutical form Tablet
    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 INNTolvaptan
    D.3.9.2Current sponsor codeOPC-41061
    D.3.9.4EV Substance CodeSUB31691
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 placeboTablet
    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 (ADPKD)
    Rene policistico autosomico dominante (ADPKD)
    E.1.1.1Medical condition in easily understood language
    ADPKD is an inherited condition (passed from ones parents) that causes cysts (fluid filled sacs) to develop on the kidneys. It causes the kidneys to get bigger over time and for the kidneys to fail.
    ADPKD è una patologia ereditaria che provoca la formazione di cisti nei reni con conseguente danno renale.
    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 17.0
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of tolvaptan treatment in
    reducing the change in estimated glomerular filtration rate
    (eGFR) from pre-treatment baseline to post-treatment followup,
    as compared with placebo, in subjects with late-stage
    chronic kidney disease (CKD) due to ADPKD who tolerate
    tolvaptan during an initial run-in period.
    Confrontare l’efficacia, rispetto al placebo, di tolvaptan nella riduzione delle variazioni del tasso di filtrazione glomerulare stimato (estimated glomerular filtration rate, eGFR) dal basale prima del trattamento al follow-up dopo il trattamento, in soggetti affetti da malattia renale cronica (chronic kidney disease, CKD) in fase avanzata dovuta ad ADPKD, che tollerano tolvaptan durante un periodo di run-in iniziale.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of tolvaptan treatment in
    reducing the decline of annualized eGFR slope, as compared
    with placebo, in subjects with late-stage CKD due to ADPKD
    who tolerate tolvaptan during an initial run-in period.
    To compare overall and hepatic safety of tolvaptan with
    placebo and to compare incidence of ADPKD complications
    (outcomes) during the trial.
    Confrontare l’efficacia, rispetto al placebo, di tolvaptan nella pendenza della riduzione dell’eGFR annualizzato, in soggetti affetti da CKD in fase avanzata dovuta ad ADPKD, che tollerano tolvaptan durante un periodo iniziale di run-in.

    Confrontare la sicurezza generale ed epatica di tolvaptan con placebo e confrontare l’incidenza delle complicazioni dell’ADPKD (esiti) durante la sperimentazione.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects age 18 to 55 years of age (inclusive) with eGFR between 25 and 65
    mL/min/1.73m2 -OR-
    2. Male and female subjects age 56 to < 66 years of age with eGFR between 25 and
    44 mL/min/1.73m2 (by medical monitor discretion, only).
    3. Male and female subjects who are tolvaptan naïve.
    4. Diagnosis of ADPKD by modified Pei-Ravine criteria18 19:
     With family history: several cysts per kidney (3 if by sonography, 5 if by CT or MRI)
     Without family history: 10 cysts per kidney (by any radiologic method, above) and exclusion
    of other cystic kidney diseases. Conditions to be excluded include: multiple simple renal
    cysts, renal tubular acidosis, cystic dysplasia of the kidney, multicystic kidney, multilocular
    cysts of the kidney, medullary cystic kidney and acquired cystic disease of the kidney.
     Distribution and number of cysts consistent with the observed level of renal function deficit
    • eGFR compreso fra 25 e 65 ml/min/1.73m2 (da 18 a 55 anni) o eGFR compreso fra 25 e 44 ml/min/1.73m2 (da 56 a < 66 anni, solo a discrezione del medical monitor).
    • Naïve a tolvaptan.
    • Diagnosi di ADPKD in base a criteri modificati di Pei-Ravine
    • Con anamnesi familiare: diverse cisti per rene (3 se valutate tramite sonografia, 5 se tramite tomografia computerizzata o risonanza magnetica).
    • Senza anamnesi familiare: 10 cisti per rene (tramite uno dei metodi radiologici indicati sopra) ed esclusione di altre malattie cistiche renali. Le condizioni di esclusione includono: cisti renali semplici multiple, acidosi tubolare renale, displasia cistica del rene, rene multicistico, cisti multiloculari del rene, rene cistico midollare e malattia cistica renale acquisita.
    • Distribuzione e numero di cisti coerente con il livello osservato di deficit della funzionalità renale.
    E.4Principal exclusion criteria
    1. Women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of
    birth control or remain abstinent during the trial and for 30 days after the last dose of IMP. If
    employing birth control, 2 of the following precautions must be used: vasectomy of partner, tubal
    ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control implant, birth
    control depot injection, condom, or sponge with spermicide.
    2. Women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving
    IMP.
    3. Need for chronic diuretic use.
    4. Hepatic impairment or liver function abnormalities other than that expected for ADPKD with
    typical cystic liver disease during the pre-randomization period.
    5. Subjects with advanced diabetes (eg, glycosylated hemoglobin [HgbA1c] > 7.5, and/or glycosuria
    by dipstick, significant proteinuria, retinopathy), evidence of additional significant renal
    disease(s) (ie, currently active glomerular nephritidies), renal cancer, single kidney, or recent
    (within last 6 months) renal surgery or acute kidney injury.
    6. Subjects with contraindications to required trial assessments.
    7. Subjects who, in the opinion of the trial investigator or medical monitor, have a medical history or
    medical findings inconsistent with safety or compliance with trial assessments.
    • Bisogno di trattamento cronico con diuretici.
    • Deficit epatico o anomalie della funzionalità epatica, diverse da quelle previste per l’ADPKD, malattia cistica del fegato durante il periodo di pre-randomizzazione.
    • Soggetti con diabete in fase avanzata (ad esempio emoglobina glicosilata [HgbA1c] > 7,5, e/o glicosuria tramite dipstick, proteinuria importante, retinopatia), ecidenza di malattie renali supplementari importanti (come nefrite glomerulae attiva in corso), tumore ai reni, rene singolo o intervento chirurgico renale recente (negli ultimi 6 mesi) o insufficienza renale acuta.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment difference in the change of eGFR from pre-treatment baseline to posttreatment
    follow-up, annualized (divided) by each subject’s IMP treatment duration.
    Differenza di trattamento nella variazione dell’eGFR dal basale pre-trattamento al follow-up post-trattamento, annualizzato (diviso) per ogni durata di trattamento con l’IMP per ogni soggetto.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout study up to the Follow up period (3 week post treatment end). The eGFR values will be calculated from the central-laboratory serum creatinine concentrations taken at screening and during every trial visit including follow up visit.
    nel corso dello studio fino al periodo di follow up (3 settimane dopo la fine del trattamento). I valori di eGFR saranno calcolati dal laboratorio centralizzato sulla concentrazione di creatinina nel siero prelevato allo screening e durante tutte le visite di studio, incluse le visite di follow up.
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoint
    Treatment difference in annualized slope of eGFR calculated for individual subjects using an appropriate baseline and available, post-randomization, on-treatment assessments.

    Safety Endpoints
    Safety endpoints to be analyzed will include a descriptive summary of:
    1) AEs
    2) Vital signs
    3) Clinical laboratory tests, including serum transaminases, BT, ALP, and serum sodium

    Pharmacokinetic/Pharmacodynamic Endpoints
    PK Endpoints: Determination of plasma tolvaptan and metabolite(s), including DM-4103 concentrations.
    PD Endpoints: Uosm and urine specific gravity
    Principale endpoint secondario di efficacia:
    Differenza di trattamento nella riduzione dell’eGFR annualizzato, calcolata per singoli soggetti utilizzando un’appropriata valutazione sul trattamento disponibile al basale e post-randomizzazione.

    Endpoint di sicurezza:
    1) EA
    2) Segni vitali
    3) Test clinici di laboratorio, inclusa transaminasi sierica, bilirubina totale (BT), fosfatasi alcalina (alkaline phosphatase, ALP) e sodio sierico.

    Endpoint PK: Metaboliti e tolvaptan nel plasma, incluse concentrazioni nel plasma di DM-4103.
    Endpoint PD: Uosm e gravità specifica delle urine.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy and Safety endpoints will be assessed throughout study up to
    and including the Follow up period (3 week post treatment end).
    PK endpoint assessed:
    End of the tolvaptan run-in period (Day -1)
    During the double-blind, randomized treatment period at Months 3, 6, 9,
    12/EoTx,
    At the last follow-up visit
    PD endpoint assessed:
    second visit of the screening period
    end of the placebo run-in period (Day -36)
    end of the tolvaptan titration period (Day -22)
    end of the tolvaptan run-in period (Day -1)
    during the double-blind, randomized treatment period at Months 3, 6, 9,
    and 12/EoTx
    at the last follow-up visit.
    Gli endpoint di efficacia e sicurezza saranno valutati durante il corso dello studio incluso il periodo di follow up (3 settimane dopo la fine del trattamento).
    Gli endpoint PK saranno valutati:
    - Alla fine del periodo di run-in con tolvaptan (day -1)
    - Durante il periodo di randomizzazione al trattamento in doppio cieco, al Mese 3, 6, 9, 12 / EoTx
    - All’ultima visita di follow up
    Gli endpoint di PD saranno valutati:
    - Alla seconda visita del periodo di screening
    - al termine del periodo di run-in con placebo (day -36)
    - al termine del periodo di titolazione con tolvaptan (day -22)
    - al termine del periodo di run-in con tolvaptan (day -1) - durante il periodo di randomizzazione al trattamento in doppio cieco al Mese 3, 6, 9 e 12 /EoTx - all’ultima visita di follow up
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) 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 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA81
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    Chile
    Colombia
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Malaysia
    Mexico
    Netherlands
    Norway
    Peru
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Turkey
    United Kingdom
    United States
    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 trial date is defined as the last date of last contact with the subject.
    la data dell’ultimo contatto con il soggetto
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 1270
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 688
    F.4.2.2In the whole clinical trial 1300
    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 who complete treatment will be offered entry into the 211
    Open Label Extension study. Patients who do not enter the 211 OLE
    will be treated as directed by their physician.
    I pazienti che completeranno il trattamento sarà data la possibilità di accedere allo studio di estensione in aperto (211). I pazienti che non dovessero entrare nell’estensione riceveranno il trattamento indicato dal medico curante.
    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 Decision2014-10-20
    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 StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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