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    Summary
    EudraCT Number:2011-004618-40
    Sponsor's Protocol Code Number:20110100
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-07-02
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2011-004618-40
    A.3Full title of the trial
    An Open-label, Single-arm Study to Assess the Safety and Tolerability of
    Cinacalcet HCl in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Years With Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Dialysis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Tolerability of Cinacalcet in Pediatric Subjects With Chronic
    Kidney Disease and Secondary Hyperparathyroidism
    A.4.1Sponsor's protocol code number20110100
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01439867
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/084/2015
    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 namecinacalcet hydrochloride
    D.3.2Product code AMG 073
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNcinacalcet
    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 namecinacalcet hydrochloride
    D.3.2Product code AMG 073
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNcinacalcet
    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 typerange
    D.3.10.3Concentration number0.2 to 1
    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 in pediatric subjects with chronic kidney disease receiving hemodialysis or peritoneal dialysis
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney Disease
    Hyperparathyroidism, Secondary
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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 corrected serum calcium levels on treatment with cinacalcet in pediatric subjects with SHPT
    E.2.2Secondary objectives of the trial
    - To characterize the pharmacokinetics (PK) in pediatric subjects
    - To characterize the pharmacodynamics (PD) in pediatric subjects
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional pharmacokinetics sub-study.
    At week 24, if appropriate consent/assent has been obtained for the
    subject to participate in an optional PK assessment sub-study, the
    subject will have a PK assessment over a 24 hour period in order to collect 10 PK samples.
    E.3Principal inclusion criteria
    Subjects between the ages of 28 days to < 6 years of age, who have CKD and SHPT undergoing either HD or PD at the time of screening (subjects 6 months or older should have been receiving dialysis for ≥ 1 month).
    - Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing
    - Screening corrected total serum calcium from the central laboratory:
    - ≥ 9.4 mg/dL (2.35 mmol/L) if age 28 days to < 2 years
    - ≥ 8.8 mg/dL (2.2 mmol/L) if age ≥ 2 to < 6 years
    - Serum phosphorus from the central laboratory:
    - ≥ 5.0 mg/dL (1.25 mmol/L) if age 28 days to < 1 year
    - ≥ 4.5 mg/dL (1.13 mmol/L) if age ≥ 1 to < 6 years
    - SHPT not due to vitamin D deficiency, per investigator assessment
    - Dry weight ≥ 7 kg at the time of screening
    E.4Principal exclusion criteria
    - History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval
    - Corrected QT interval (QTc) > 500 ms, using Bazett’s formula
    - 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
    - Use of grapefruit juice, herbal medications, CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole), or CYP2D6 substrates (eg, flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine)
    - Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) for ages 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for ages ≥ 2 to < 6 years during the study
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Study (The time when the last subject completes the last study
    visit assessment)
    E.5.2Secondary end point(s)
    1. Occurrence of corrected serum calcium < 8.8 mg/dL (2.2 mmol/L) during the study
    2. PK parameters at week 12 (eg, maximum plasma concentration (Cmax), area under the curve (AUC), apparent clearance (CL/F), apparent volume of distribution (V/F))
    3. The percent change of plasma iPTH, corrected total serum calcium, serum phosphorous, and Ca x P from baseline to scheduled visits during the study
    4. Achievement of ≥ 30% reduction from baseline in plasma iPTH during the study
    5. Achievement of plasma iPTH values between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any 2 consecutive measurements
    6. Achievement of plasma iPTH values < 300 pg/mL (31.8 pmol/L) during the study
    7. Safety endpoints:
    - Nature, frequency, severity, and relationship to treatment of all adverse events, including those of special interest, reported during the study
    - Changes in laboratory parameters, including clinical chemistry, at scheduled visits
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) End of Study (The time when the last subject completes the last study
    visit assessment)
    2)Week 12 and week 24 for subjects participating to the PK sub-study
    3)Each study visit
    4) End of Study
    5) Each study visit
    6) End of study
    7) Each study visit
    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) 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 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.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Mexico
    Russian Federation
    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
    The time when the last subject completes the last study visit assessment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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: 30
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 25
    F.1.1.6Adolescents (12-17 years) No
    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
    Subjects < 6 years of age:
    Subject's parent, or legally acceptable guardian, must sign an
    Independent Ethics Committee (IEC) approved Informed Consent Form.
    At the discretion of the investigator, subject assent may also be
    obtained.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    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)
    Expected normal treatment
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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