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    Summary
    EudraCT Number:2018-004608-21
    Sponsor's Protocol Code Number:20170724
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-06-28
    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 ConcernedPortugal - INFARMED
    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.
    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
    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 Biofarmacêutica, Lda.
    B.5.2Functional name of contact pointMedical Information Department
    B.5.3 Address:
    B.5.3.1Street AddressAv. José Malhoa 19, Piso 5
    B.5.3.2Town/ cityLisboa
    B.5.3.3Post code1070-157
    B.5.3.4CountryPortugal
    B.5.4Telephone number+35121422 06 06
    B.5.5Fax number+35121422 05 99
    B.5.6E-mailMedInfoPT@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.3.4Pharmaceutical 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 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 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.
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    101. 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.
    102. Male or female subjects ≥ 2 to < 18 years of age at the time of enrollment.
    103. Targeted dry weight ≥ 7 kg at the time of screening Week -1.
    104. Diagnosed with CKD and SHPT undergoing hemodialysis/hemodiafiltration TIW at the time of screening ≥1 month.
    105. 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 .
    106. Serum cCa value ≥ 9.0 mg/dL (2.25 mmol/L) obtained from the central laboratory during screening.
    107. Dialysate Ca level ≥ 2.5 mEq/L for at least 1 month prior to screening and throughout the duration of the study.
    108. Subject receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain
    stable doses for the duration of the study, except for adjustments allowed per protocol.
    109. Subject receiving phosphate binders must have had no more than a maximum
    dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable dose for the duration of the study, except for adjustments allowed per protocol.
    110. Subject receiving Ca supplements must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain
    stable dose for the duration of the study, except for adjustments allowed per protocol.
    111. SHPT not due to vitamin D deficiency, per investigator assessment.
    E.4Principal exclusion criteria
    201 History of congenital long QT syndrome, 2nd or 3rd degree heart block, ventricular tachyarrhythmia’s, history of symptomatic ventricular dysrhythmias Torsades de Pointes or other conditions associated with prolonged QT interval
    202 Anticipated or scheduled parathyroidectomy during the study period
    203 Anticipated or scheduled kidney transplant during the study period
    204 Subject has received a parathyroidectomy within 6 months prior to enrollment
    205 Current malignancy or history of other malignancy, except non-melanoma skin cancers within the last 5 years
    Prior/Concomitant Therapy
    206 Use of concomitant medications that may prolong the QTc (eg, ondansetron, albuterol, sotalol, amiodarone, erythromycin, or clarithromycin).
    207 Receipt of cinacalcet therapy within 30 days prior screening and through enrollment
    208 Receipt of etelcalcetide therapy within 6 months prior screening and through enrollment
    209 All herbal medicines (eg, St. John’s wort), vitamins, and supplements consumed by the subject within the 30 days prior to enrollment, and continuing use if applicable, will be reviewed by the Principal Investigator and the Amgen Medical
    Monitor. Written documentation of the review and Amgen acknowledgment is required for subject participation
    210 Use of any over-the-counter or prescription medications within the 14 days or 5 half-lives (whichever is longer) prior to enrollment 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 the review and Amgen acknowledgment is required for subject participation. Paracetamol for analgesia will be allowed
    Prior/Concurrent Clinical Study Experience
    211 Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded
    212 Subject has significant abnormalities on the most recent central laboratory test during the screening period prior to enrollment per the Investigator including but not limited to the following: a. Serum transaminase (alanine aminotransferase [ALT] or serum glutamic pyruvic transaminase [SGPT], aspartate aminotransferase [AST], or serum glutamic oxaloacetic transaminase [SGOT]) > 1.5 times the upper limit of normal (ULN)
    213 Corrected QT interval > 500 ms, using Bazett’s formula
    214 Corrected QT interval ≥ 450 to ≤ 500 ms, using Bazett’s formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
    215 Subject has a clinically significant electrocardiogram (ECG) abnormality (eg, unstable arrhythmia) during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation
    216 New onset or worsening of a pre-existing seizure disorder
    217 Subjects on anti-convulsant medication must be on a stable and therapeutic dose for 3 months prior to screening (if blood level monitoring is clinically available, then the subject must have a therapeutic blood level within 1 week of enrollment)
    218 Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 3 months after the last dose of etelcalcetide. (Females of childbearing potential should only be included in the study after a confirmed menstrual period and a negative highly sensitive serum pregnancy test within 7 days prior to the first dose of investigational product)
    219 Female subjects of childbearing potential unwilling to use 1 highly effective or acceptable method of effective contraception during treatment and for an additional 3 months after the last dose of investigational product
    220 Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a serum pregnancy test
    221 Subject has known sensitivity to etelcalcetide or excipients to be administered during dosing
    222 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
    223 History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) or unacceptable physical findings, that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
    224 Subject previously has entered this study or previously received treatment with etelcalcetide
    225 Anemia, which in the opinion of the investigator makes it not advisable to undergo sequential blood draws
    226 History of unstable chronic heart failure within the last 1 year prior to screening
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, Week 20, 21, 22, 23, 24, 25 and 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).
    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/post-dialysis), Week 17 (pre-dialysis/post-dialysis), Week 21 (pre-dialysis/post-dialysis), Week 27 (pre-dialysis), End of Study (pre-dialysis).
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    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.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 24
    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: 14
    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.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 24
    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.
    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 Decision2019-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-04
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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