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    Summary
    EudraCT Number:2014-003563-38
    Sponsor's Protocol Code Number:20140159
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-25
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2014-003563-38
    A.3Full title of the trial
    A Multicenter Single-arm Extension Study to Characterize the Long-term
    Safety of Cinacalcet Hydrochloride in the Treatment of Secondary
    Hyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease on
    Dialysis
    Multicentrické, jednoramenné navazující klinické hodnocení
    charakterizující dlouhodobou bezpečnost cinakalcet hydrochloridu v léčbě
    sekundární hyperparatyreózy u pediatrických pacientů s chronickým
    onemocněním ledvin na hemodialýze
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Characterize the Long-term Safety of Cinacalcet Hydrochloride in the Treatment of Secondary Hyperparathyroidism in Children With Chronic Kidney Disease On Dialysis
    A.4.1Sponsor's protocol code number20140159
    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 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 code(CH-)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 namecincacalet hydrochloride
    D.3.2Product code AMG 073
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 364782-34-3
    D.3.9.3Other descriptive nameCINACALCET HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20068
    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.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecincacalet hydrochloride
    D.3.2Product code AMG 073
    D.3.4Pharmaceutical form Suspension and effervescent granules for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 364782-34-3
    D.3.9.3Other descriptive nameCINACALCET HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20068
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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: 3
    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 Mimpara®
    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 nameCinacalcet
    D.3.2Product code AMG 073
    D.3.4Pharmaceutical form Film-coated 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 INNCinacalcet
    D.3.9.1CAS number 364782-34-3
    D.3.9.2Current sponsor codeAMG 073
    D.3.9.3Other descriptive nameCINACALCET HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20068
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving
    Dialysis
    E.1.1.1Medical condition in easily understood language
    Secondary Hyperparathyroidism and Chronic Kidney Disease
    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 characterize the long-term safety and tolerability of cinacalcet in pediatric subjects with CKD receiving dialysis
    E.2.2Secondary objectives of the trial
    To characterize the long-term effect of cinacalcet in pediatric subjects receiving dialysis on laboratory parameters associated with CKD-MBD
    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 day 1 study-specific
    activities/procedures being initiated.
    102 Dialysate calcium concentration ≥ 2.5 mEq/L at day 1

    All subjects with > 14 days between the last study visit in Study
    20130356 or Study 20110100 and screening for Study 20140159:
    103 Subjects on anti-convulsant medication must be on a stable dose

    All subjects from 20130356:
    104 Completed treatment through week 20 in the 20130356 study or on
    study at the time of Study 20130356 termination
    105 Dry weight ≥ 12.5 kg at day 1 of Study 20140159

    Subjects Randomized to the 20130356 Standard of Care Arm Only:
    106 iPTH value ≥ 300 pg/mL (within 7 days of day 1 in Study 20140159)
    (week 19 in 20130356)
    107 Corrected calcium value ≥ 8.8 mg/dL within 7 days of day 1 in Study 20140159 (week 19 in20130356)

    All Subjects from 20110100
    108 Completed week 26 End of Study visit in the, 20110100 study or on
    study at the time of Study 20110100 termination
    109 Dry weight ≥ 7 kg at day 1 of Study 20140159
    E.4Principal exclusion criteria
    General:
    Studies 20130356 or 20110100
    201 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(s), other than Amgen Studies
    20130356 or 20110100.
    202 Other investigational procedures while participating in this study
    are excluded.
    203 Malignancy except non-melanoma skin cancers, cervical or breast
    ductal carcinoma in situ within the last 5 years.
    204 Subject has known sensitivity to any of the products to be
    administered during dosing.
    205 Subject likely to not be available to complete all protocol-required
    study visits or procedures, and/or to comply with all required study
    procedures (eg, electronic patient diary [ediary]) to the best of the
    subject and investigator's knowledge
    206 History or evidence of any other clinically significant disorder,
    condition or disease (with the exception of those outlined above) 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.
    207 Subject previously has entered this study.
    208 If sexually active, subject is not willing to use acceptable
    contraception during treatment and for at least 9 days after the end of
    treatment
    209 Subject is pregnant or breast feeding, or planning to become
    pregnant during the study or within 9 days after the end of treatment
    210 History of congenital long QT syndrome, second or third degree
    heart block, ventricular tachyarrythmias, or other conditions associated
    with prolonged QT interval
    211 A new onset of seizures or worsening of pre-existing seizure
    disorder
    All Subjects with > 14 days between the last study visit in Study
    20130356 or

    Study 20110100 and the screening visit in Study 20140159
    212 Unstable chronic heart failure defined as worsening pulmonary
    edema or
    other signs and symptoms as per investigator assessment during
    screening
    will have the following exclusion criteria applied during screening and
    day 1:
    213 Received therapy with commercial cinacalcet after the last study
    visit in
    Study 20130356 or Study 20110100 before day 1 of Study 20140159
    214 Scheduled date for kidney transplantation from a known living donor
    that
    makes completion of the study unlikely
    215 Either new or recurrent cardiac ventricular arrhythmias requiring a
    change
    in treatment within 10 days prior to screening visit or day 1 of Study 20140159 screening
    216 Hepatic impairment indicated by elevated levels of hepatic
    transaminase or
    bilirubin (aspartate aminotransferase [AST] ≥ 1.5 × upper limit of
    normal
    [ULN] OR alanine aminotransferase [ALT] ≥ 1.5 × ULN OR total
    bilirubin ≥ 1 × ULN per institutional laboratory range) during screening
    217 Subject has an ongoing adverse event from Studies 20130356 or
    20110100 that is considered related to IP and:

    All Subjects - Day 1 Study Visit
    • Is ≥ CTCAE (v 4.0) grade 3, and/or
    • Considered clinically significant in the opinion of the investigator
    218 Central laboratory values were not obtained/are not available at day
    1 in
    Study 20140159
    219 Corrected QT Interval (QTc) > 500 ms, using Bazett's formula
    220 QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written
    permission to
    enroll is provided by the investigator after consultation with a pediatric
    cardiologist
    221 Use of grapefruit juice, herbal medications, CYP3A4 inhibitors (eg,
    erythromycin, clarithromycin, ketoconazole, itraconazole), or CYP2D6
    substrates
    (eg, flecainide, propafenone, metoprolol, desipramine, nortriptyline,
    clomipramine)
    222 Use of concomitant medications that may prolong the QTc interval
    (eg, ondansetron, albuterol)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is subject incidence of events of interest (EOI; hypocalcemia, convulsions, hypotension, worsening of heart failure, hypersensitivity, ischemic heart disease, QT prolongation/ventricular tachyarrhytmias, fracture, acute pancreatitis, drug-related hepatic disorders, nervous system disorders [excluding seizures], neoplastic events, and infection).
    E.5.2Secondary end point(s)
    Study 20140159 only:
    • Achievement of ≥ 30% reduction from baseline to mean intact
    parathyroid
    hormone (iPTH) during weeks 11 and 15 (standard of care [SOC] arm of
    Study 20130356 only)
    • Achievement of ≥ 30% reduction from baseline to mean iPTH during
    weeks 23 and 28 (SOC arm of Study 20130356 only)
    • Percent change from baseline to mean iPTH during weeks 23 and 28
    (SOC
    arm of Study 20130356 only)
    • Change in corrected total serum calcium from baseline to mean value
    during weeks 23 and 28
    • Change in serum phosphorus from baseline to mean value during
    weeks 23 and 28
    • Achievement of a mean iPTH ≤ 300 pg/mL during weeks 23 and 28
    • Percent change from day 1 in intact parathyroid hormone (iPTH) to
    week 11 and week 28
    • Serum corrected calcium (cCa) at baselinevalues at day 1, week 11, and
    week 28
    • Serum phosphorus at baselinevalues at day 1, week 11, and week 28
    Combined Studies 20130356, 20110100, and 20140159:
    • Achievement of ≥ 30% reduction from day 1 of cinacalcet treatment to
    mean iPTH during weeks 11 and 15
    • Achievement of ≥ 30% reduction from day 1 of cinacalcet treatment to
    mean iPTH during weeks 23 and 28
    • Percent change in iPTH over time from day 1 of cinacalcet treatment
    • Change in serum cCa over time from day 1 of cinacalcet treatment
    • Change in serum phosphorus over time from day 1 of cinacalcet
    treatment
    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 No
    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 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 EEA26
    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
    Belgium
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Italy
    Lithuania
    Mexico
    New Zealand
    Poland
    Portugal
    Russian Federation
    Slovakia
    Spain
    Ukraine
    United States
    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
    End of Study per protocol is defined as when the last subject is assessed or receives an intervention for the purposes of final collection of data.
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    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: 48
    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: 24
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 24
    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 No
    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 No
    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 24
    F.4.2.2In the whole clinical trial 48
    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)
    There will be a 4-week safety follow-up period for this study.
    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 Decision2015-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-15
    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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