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    The EU Clinical Trials Register currently displays   42869   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2021-000894-94
    Sponsor's Protocol Code Number:KOR-PED-201
    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:2021-08-30
    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 number2021-000894-94
    A.3Full title of the trial
    An Open-label, Single Arm Study to Evaluate the Pharmacokinetics of a Single Dose of Intravenous Difelikefalin in Adolescents Aged 12 to 17 Years on Haemodialysis
    Studio in aperto, a braccio singolo volto a valutare la farmacocinetica di una dose singola di Difelikefalin per via endovenosa in adolescenti di età compresa tra 12 e 17 anni in emodialisi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Single dose study to evaluate how intravenous administered difelikefalin is absorbed by and cleared from Adolescents on Haemodialysis
    Studio a dose singola per valutare come difelikefalin somministrato per via endovenosa viene assorbito ed eliminato dagli adolescenti in emodialisi
    A.3.2Name or abbreviated title of the trial where available
    Pharmacokinetics and Safety of Difelikefalin in Adolescents on Haemodialysis
    Farmacocinetica e sicurezza di Difelikefalin in adolescenti in emodialisi
    A.4.1Sponsor's protocol code numberKOR-PED-201
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/172/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVifor Fresenius Medical Care Renal Pharma Ltd.
    B.1.3.4CountrySwitzerland
    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 supportVifor Fresenius Medical Care Renal Pharma Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVifor Fresenius Medical Care Renal Pharma Ltd.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressFlughofstrasse 61
    B.5.3.2Town/ cityGlattbrugg
    B.5.3.3Post codeCH-8152
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41588518000
    B.5.5Fax number+41588518001
    B.5.6E-mailKOR-PED-201.study@viforpharma.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 nameDifelikefalin
    D.3.2Product code [CR845]
    D.3.4Pharmaceutical form Solution for infusion
    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 INNDIFELIKEFALIN
    D.3.9.1CAS number 1024828-77-0
    D.3.9.2Current sponsor codeCR845
    D.3.9.3Other descriptive nameDIFELIKEFALIN
    D.3.9.4EV Substance CodeSUB195302
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Renal disease in the final stage
    Nefropatia allo stadio terminale
    E.1.1.1Medical condition in easily understood language
    Renal disease in the final stage
    Malattia renale allo stadio terminale
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10014646
    E.1.2Term End stage renal disease (ESRD)
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10077512
    E.1.2Term End stage renal disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the PK profile of a single dose of difelikefalin in adolescent subjects aged 12 to 17 years on HD
    Valutare il profilo farmacocinetico (PK) di una dose singola di difelikefalin in adolescenti di età compresa tra 12 e 17 anni in HD.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of a single dose of difelikefalin in adolescent subjects aged 12 to 17 years on HD
    Valutare la sicurezza e la tollerabilità di una dose singola di difelikefalin in adolescenti di età compresa tra 12 e 17 anni in HD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.End-stage renal disease (ESRD) subjects who have been on HD for at least 3 months and are currently on HD at least 3 times per week. Subjects with or without associated pruritus may enroll.
    2.Males or females 12 to 17 years of age, at the time of consent.
    3.Has a prescription dry body weight =20 kg and =100 kg
    1. Soggetti con malattia renale in stadio terminale (ESRD) che sono stati in HD per almeno 3 mesi e sono attualmente in trattamento con HD almeno 3 volte alla settimana. Possono essere arruolati soggetti con o senza prurito associato.
    2. Soggetti di sesso maschile o femminile di età compresa fra 12 e 17 anni al momento del consenso.
    3. Soggetti con un peso corporeo secco prescritto =20 kg e =100 kg.
    E.4Principal exclusion criteria
    1.Known to be non compliant with HD treatments and deemed unlikely to complete the study by the Investigator (i.e., has a history of missed HD sessions due to non adherence in the past 2 months).
    2.Planned or anticipated to receive a kidney transplant during the study. Note: Being on a kidney transplant list is not an exclusion criterion.
    3.Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5 × the reference upper limit of normal (ULN), or bilirubin greater than 4 × the ULN at screening.
    4.Subject has known hypersensitivity to the study drug or any components of the difelikefalin formulation.
    5.Known history of allergic reaction to opiates such as hives. Note: Side effects related to the use of opioids such as constipation or nausea would not exclude the subjects from the study.
    6.Previous participation in this study.
    7.Known or suspected history of alcohol, narcotic, or other drug abuse or substance dependence within 12 months prior to screening.
    8.Acute or unstable medical condition(s) which in the opinion of the Investigator would pose undue risk to the subject or would impede complete collection of evaluable data.
    1. Nota mancata compliance ai trattamenti di HD e improbabilità che lo studio sia completato secondo il giudizio dello Sperimentatore (ovvero, anamnesi di sessioni di HD saltate per mancata aderenza negli ultimi 2 mesi).
    2. Trapianto di rene pianificato o previsto durante lo studio. Nota: Essere in lista per un trapianto di rene non costituisce criterio di esclusione.
    3. Alanina aminotransferasi (ALT), aspartato aminotransferasi (AST) nel siero superiori a 2,5 volte il limite superiore della norma (ULN) o bilirubina superiore a 4 x ULN allo screening.
    4. Soggetto con ipersensibilità nota al farmaco in studio o a qualsiasi componente della formulazione di difelikefalin.
    5. Anamnesi nota di reazione allergica agli oppiacei, ad esempio orticaria. Nota: Gli effetti collaterali associati all'uso di oppioidi come la costipazione o la nausea non escluderebbero i soggetti dallo studio.
    6. Precedente partecipazione a questo studio
    7. Anamnesi nota o sospetta di abuso di alcol, narcotici o altre droghe o dipendenza da sostanze nei 12 mesi precedenti lo screening.
    8. Condizioni mediche acute o instabili che, secondo il giudizio dello Sperimentatore, comporterebbero un rischio eccessivo per il soggetto o impedirebbero la raccolta completa di dati valutabili
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetics profile of difelikefalin after a single dose post haemodialysis
    Profilo PK di difelikefalin dopo una dose singola post HD
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over a 3 day period
    un periodo di 3 giorni
    E.5.2Secondary end point(s)
    Incidence of adverse events (AEs) and serious adverse events (SAEs) after a single dose of difelikefalin. Change in vital signs, 12 lead electrocardiogram (ECG), and clinical safety laboratory evaluations after a single dose of difelikefalin
    Incidenza di eventi avversi (AE) ed eventi avversi seri (SAE) dopo una dose singola di difelikefalin. Alterazione dei parametri vitali, dell'elettrocardiogramma a 12 derivazioni (ECG) e delle valutazioni cliniche di laboratorio di sicurezza dopo una dose singola di difelikefalin
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over 7 days
    7 giorni successivi
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    Tollerabilita
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    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 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
    Italy
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Subject Last Visit (LSLV)
    Ultima visita ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3
    F.4.2.2In the whole clinical trial 6
    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
    Non applicabile
    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 Decision2021-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-08
    P. End of Trial
    P.End of Trial StatusOngoing
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