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    Summary
    EudraCT Number:2015-005051-28
    Sponsor's Protocol Code Number:20140336
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-005051-28
    A.3Full title of the trial
    An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Etelcalcetide (AMG 416) in Paediatric Subjects Aged 2 to less than 18 Years with Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Safety and action of Etelcalcetide (AMG 416) in Paediatric Subjects Aged 2 to less than 18 Years with Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
    A.4.1Sponsor's protocol code number20140336
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    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 (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@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 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 nameetelcalcetide
    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 (AMG 416)
    D.3.9.1CAS number 8000019-76-3
    D.3.9.3Other descriptive namePOLYPEPTIDE
    D.3.9.4EV Substance CodeSUB14950MIG
    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 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
    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
    E.1.1.1Medical condition in easily understood language
    Secondary Hyperparathyroidism (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 19.0
    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 safety and tolerability of etelcalcetide after single dose administration to paediatric subjects aged 2 to less than 18 years with secondary hyperparathyroidism (sHPT) receiving maintenance haemodialysis
    E.2.2Secondary objectives of the trial
    To evaluate the pharmacokinetic profile of plasma etelcalcetide, serum PTH and serum calcium (total calcium, ionized calcium and albumin corrected calcium) levels following single intravenous (IV) administration of etelcalcetide.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    101 Subject’s legally acceptable representative has provided 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.
    102 Male or female subjects (aged 2 to less than 18 years) diagnosed with CKD and sHPT and receiving maintenance haemodialysis or haemodiafiltration for > 30 days prior to screening.
    103 Subject must be on a dialysate calcium concentration of ≥ 2.5 mEq/L (1.25 mmol/L) for at least 1 month prior to enrollment and throughout the duration of the study.
    104 Screening and Baseline serum PTH level > 200 pg/mL (21 pmol/L).
    105 Subject must weigh ≥ 7 kg at Baseline (Day -2).
    106 Screening and Baseline serum corrected calcium from the local laboratory ≥ 9 mg/dL (2.25 mmol/L).
    107 Subjects on anti-convulsant medication must be on a stable dose for 3 months.
    108 Free of any disease or condition other than those diseases or conditions related to their renal disease that, in the opinion of the investigator, would impact the subject’s safety or the integrity of the study data.
    E.4Principal exclusion criteria
    201 Currently receiving or has received any investigational drug (or is currently using an investigational device) within the 30 days or 5 half-lives (whichever is longer), prior to receiving the first dose of etelcalcetide. Other investigational procedures while participating in this study are excluded.
    202 Subject previously has entered this study or previously exposed to etelcalcetide.
    203 All herbal medicines (eg, St. John’s wort), vitamins, and supplements consumed by the subject within the 30 days prior to receiving the first dose of etelcalcetide, and continuing use if applicable, will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of this review and Amgen acknowledgment is required for subject participation.
    204 Use of any over-the-counter or prescription medications within the 14 days or 5 half-lives (whichever is longer) prior to receiving the first dose of etelcalcetide that are not established therapies for subjects with renal disease or other conditions secondary to renal disease will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of this review and Amgen acknowledgment is required for subject participation. Paracetamol (up to 2 g per day) for analgesia will be allowed.
    205 Malignancy except non-melanoma skin cancers,within the last 5 years.
    206 History of hypersensitivity or allergic reaction to any of the excipients listed in Section 6.2.1. (protocol)
    207 Subject received cinacalcet therapy within less than 30 days prior to etelcalcetide dosing.
    208 A new onset of seizure or worsening of a pre-existing seizure disorder within 2 months prior to etelcalcetide administration.
    209 Subject’s screening 12-lead ECG suggests unstable arrhythmia or other cardiac abnormality that could place the subject at increased risk, based upon the Investigator’s opinion.
    210 History of prolongation of the QT interval (eg, congenital long QT interval, second or third degree heart block or other conditions which prolong the QT interval) or history of ventricular arrhythmias.
    211 Concurrent or within 28 days prior to enrollment use of medications that prolong QT interval (eg, sotalol, amiodarone, erythromycin, or clarithromycin). Please refer to the complete QT prolongation medication list at
    http://www.crediblemeds.org/pdftemp/pdf/CompositeList.pdf
    212 Subjects with a corrected QT Interval (QTc) > 500 ms during screening, using Bazett’s formula.
    213 Subject has a history of symptomatic ventricular dysrhythmias or Torsades de Pointes.
    214 Subject has a screening ALT or AST from the local lab ≥ 1.5 times the upper limit of normal (ULN).
    215 Female subjects of childbearing potential who are unwilling to practice true sexual abstinence or use an acceptable method(s) of effective birth control during treatment through 3 months after receiving the etelcalcetide.
    216 Post-menarchal subject who is pregnant or breastfeeding, or is planning to become pregnant or breastfeed during treatment and for an additional 3 months after etelcalcetide administration. Female subjects with a positive pregnancy test
    at screening.
    217 Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator’s knowledge.
    E.5 End points
    E.5.1Primary end point(s)
    • Common treatment-emergent adverse events [including changes in physical examinations]
    • Changes in key laboratory safety tests [albumin corrected calcium (cCalcium), phosphorus, potassium, parathyroid hormone (PTH)], ECGs and vital signs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1-30
    E.5.2Secondary end point(s)
    • Pharmacokinetic parameters (AUC, Cmax, tmax, t1/2) of etelcalcetide in plasma
    • Pharmacodynamics: concentration of parathyroid hormone (PTH), serum calcium [total calcium, ionized calcium and albumin corrected calcium] over time
    • Anti-etelcalcetide antibodies
    • Incidence of treatment-emergent adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1-30
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    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) 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 Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 No
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days15
    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: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    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 No
    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
    Paediatric patients
    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 10
    F.4.2.2In the whole clinical trial 10
    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)
    Normal treatment of the condition
    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 Decision2016-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-29
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