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    Summary
    EudraCT Number:2018-004608-21
    Sponsor's Protocol Code Number:20170724
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 number2018-004608-21
    A.3Full title of the trial
    Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents > = 2 to < 18 Years of age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis.
    Studio di fase 3 a singolo braccio, in aperto, multidose, di titolazione, per valutare la farmacocinetica, la farmacodinamica e la sicurezza di etelcalcetide in bambini e adolescenti di età compresa tra > = 2 e < 18 anni con iperparatiroidismo secondario e malattia renale cronica sottoposti a emodialisi di mantenimento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
    Studio di fase 3 su Etelcalcetide in bambini con iperparatiroidismo secondario sottoposti a emodialisi
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number20170724
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/173/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAMGEN 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen S.r.l.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressVia Tazzoli 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number0039026241121
    B.5.6E-mailmedicalinformationitaly@amgen.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 Yes
    D.2.1.1.1Trade name PARSABIV
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameetelcalcetide
    D.3.2Product code [AMG 416]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETELCALCETIDE
    D.3.9.2Current sponsor codeAMG 416
    D.3.9.4EV Substance CodeSUB178987
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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
    Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
    Iperparatiroidismo secondario (SHPT) nei pazienti pediatrici con malattia renale cronica (CKD) in emodialisi.
    E.1.1.1Medical condition in easily understood language
    Secondary Hyperparathyroidism (sHPT)
    Iperparatiroidismo secondario (sHPT)
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020708
    E.1.2Term Hyperparathyroidism secondary
    E.1.2System Organ Class 10014698 - Endocrine 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 efficacy of etelcalcetide in reducing the intact parathyroid hormone (iPTH) level in children ages > = 2 to < 18 years with secondary hyperparathyroidism (SHPT) receiving maintenance hemodialysis.
    Valutare l'efficacia di etelcalcetide nel ridurre i livelli di paratormone intatto (iPTH) in bambini di età compresa tra > = 2 e < 18 anni con iperparatiroidismo secondario (SHPT) sottoposti emodialisi di mantenimento
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of etelcalcetide in reducing the iPTH level by > 30%.
    - To characterize change in laboratory markers of chronic kidney disease (CKD) following etelcalcetide treatment.
    - To characterize the safety of etelcalcetide treatment based on laboratory values.
    - To characterize the pharmacokinetic (PK) of etelcalcetide treatment after single and multiple doses.
    - Valutare l'efficacia di etelcalcetide nel ridurre i livelli di iPTH di > 30%
    - Caratterizzare la mutazione dei marker di laboratorio della malattia renale cronica (CKD) in seguito al trattamento con etelcalcetide
    - Caratterizzare la sicurezza del trattamento con etelcalcetide sulla base dei valori di laboratorio
    - Caratterizzare la farmacocinetica (PK) del trattamento con etelcalcetide dopo dose singola e dose multipla
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
    - Male or female subjects > = 2 to < 18 years of age at the time of enrollment.
    - Targeted Dry weight > = 7 kg at the time of screening week -1
    - Diagnosed with CKD and SHPT undergoing hemodialysis/hemodiafiltration TIW at the time of screening > = 1 month.
    - Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values > 300 pg/mL during screening, on separate days and within 2 weeks of enrollment obtained from the central laboratory during screening.

    *Please, refers to procotol for the full list.
    - Il rappresentante legalmente accettabile del soggetto ha fornito il consenso informato quando il soggetto è legalmente troppo giovane per fornire il consenso informato e il paziente ha fornito un assenso scritto sulla base di regolamenti locali e/o linee guida prima di avviare qualsiasi attività/procedura studio specifica
    - Soggetti di sesso maschile o femminile di età compresa tra > = 2 e < 18 anni al momento dell'arruolamento
    - Peso > = 7 kg al momento dello screening, settimana 1
    - Diagnosi con CKD e SHPT sottoposti ad emodialisi / emodiafiltrazione TIW al momento dello screening > = 1 mese
    - Diagnosi di SHPT con la media dei 2 valori consecutivi di iPTH emersi dalle analisi del laboratorio centrale > 300 pg/mL durante lo screening, in giorni diversi ed entro 2 settimane dall'arruolamento

    *Fare riferimento al protocollo per la lista completa
    E.4Principal exclusion criteria
    - History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia's, history of symptomatic ventricular dysrhythmias Torsades de Pointes or other conditions associated with prolonged QT interval.
    - Anticipated or scheduled parathyroidectomy during the study period.
    - Anticipated or scheduled kidney transplant during the study period.
    - Subject has received a parathyroidectomy within 6 months prior to enrollment.
    - Current malignancy or history of other malignancy, except nonmelanoma skin cancers within the last 5 years. Prior/Concomitant Therapy
    - Use of concomitant medications that may prolong the QTc (eg, ondansetron, albuterol, sotalol, amiodarone, erythromycin, or clarithromycin).

    *Please, refers to protocol for the full list.
    - Anamnesi di sindrome congenita del QT lungo, blocco cardiaco di secondo o terzo grado, tachiaritmia ventricolare, anamnesi di aritmie ventricolari sintomatiche torsioni di punta o altre condizioni associate all'intervallo QT prolungato.
    - Paratiroidectomia prevista o programmata durante lo studio
    - Trapianto di rene previsto o programmato durante lo studio
    - Il soggetto ha subito una paratiroidectomia nei 6 mesi precedenti l'arruolamento
    - Malignità attuale o storia di altre neoplasie maligne, tranne i tumori della pelle non melanoma negli ultimi 5 anni. Terapia preventiva / concomitante
    - Uso concomitante di farmaci che potrebbero prolungare il QTc (es. ondansetron, albuterolo,sotalolo, amiodarone, eritromicina o claritromicina)

    *Fare riferimento al protocollo per la lista completa
    E.5 End points
    E.5.1Primary end point(s)
    Percent change in iPTH from baseline during the efficacy assessment period (EAP) at weeks 20 to 26.
    Variazione percentuale nell'iPTH rispetto al basale durante il periodo di valutazione dell'efficacia (EAP) nelle settimane da 20 a 26.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, Week 20, 21, 22, 23, 24, 25 and 26.
    Giorno 1, Settimana 20, 21, 22, 23, 24, 25 e 26.
    E.5.2Secondary end point(s)
    - Achievement of a > 30% reduction from baseline in mean iPTH during the EAP.
    - Percent change from baseline in corrected total serum calcium (Ca) and serum phosphorus from baseline during the EAP.
    - Occurrence of corrected serum Ca levels < 8.0 mg/dL (2.0 mmol/L) any time during the study.
    - Changes in laboratory parameters, including clinical chemistry.
    - Occurrence of hypocalcemia (corrected serum Ca levels < 8.4 mg/dL).
    - Etelcalcetide plasma concentrations before and at the end of dialysis after single and multiple doses.
    - Etelcalcetide PK parameters including, but not limited to, maximum plasma concentration (Cmax) and plasma trough concentrations (Cmin).
    - Raggiungimento di una riduzione > 30% nell'IPTH medio rispetto al basale durante l'EAP.
    - Variazione percentuale rispetto al basale dei livelli sierici di calcio (Ca) corretto totale e del fosforo sierico rispetto al basale durante l'EAP
    - Rilevazione di livelli di Ca sierici corretti <8,0 mg/dL (2,0 mmol/L) in qualsiasi momento durante lo studio
    - Variazioni nei parametri di laboratorio, inclusi i parametri ematochimici
    - Rilevazione di ipocalcemia (livelli di Ca sierici corretti <8,4 mg/dL)
    - Concentrazioni plasmatiche di etelcalcetide prima e al termine della dialisi dopo dosi singole e multiple
    - Parametri PK dell'etelcalcetide inclusi, ma non limitati a, concentrazione plasmatica massima (Cmax) e concentrazioni plasmatiche a valle (Cmin)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Day 1, Week 20, 21, 22, 23, 24, 25 and 26
    - Day 1, Week 20, 21, 22, 23, 24, 25 and 26
    - Weekly throughout study
    - Day 1 (pre-dialysis/post-dialysis), Week 5 (pre-dialysis/post-dialysis), Week 9 (pre-dialysis/post-dialysis), Week 13 (pre-dialysis/postdialysis), Week 17 (pre-dialysis/post-dialysis), Week 21 (predialysis/post-dialysis), Week 27 (pre-dialysis), End of Study (predialysis).
    - Giorno 1, Settimana 20, 21, 22, 23, 24, 25 e 26
    - Giorno 1, Settimana 20, 21, 22, 23, 24, 25 e 26
    - Settimanalmente durante lo studio
    - Giorno 1 (pre-dialisi/post-dialisi), Settimana 5 (pre-dialisi/post-dialisi), Settimana 9 (pre-dialisi/post-dialisi), Settimana 13 (pre-dialisi/post-dialisi), Settimana 17 (pre-dialisi/post-dialisi), Settimana 21 (pre-dialisi/post-dialisi), Settimana 27 (pre-dialisi/post-dialisi), conclusione dello studio (pre-dialisi).
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 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
    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 months10
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days9
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under age incapable of giving consent personally
    Minori incapaci di dare il consenso personalmente
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2019-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-23
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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