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    Summary
    EudraCT Number:2012-000171-17
    Sponsor's Protocol Code Number:SPD405-207
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2013-08-01
    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 number2012-000171-17
    A.3Full title of the trial
    A Three Part Open-Label Study to Assess the Pharmacokinetics of
    Lanthanum Carbonate, compare the Efficacy, Safety and Tolerability of 8
    weeks treatment with Lanthanum Carbonate and Calcium Carbonate using
    a Crossover design and Investigate the Efficacy and Safety of 12 months
    of Treatment with Lanthanum Carbonate in Hyperphosphataemic Children
    and Adolescents aged 6 months to Less Than 18 years with Chronic Kidney
    Disease on Dialysis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare treatment for hyperphosphataemia in children
    suffering from renal failure with a new product called Lanthanum oral
    powder with an established treatment called calcium carbonate.
    A.4.1Sponsor's protocol code numberSPD405-207
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/057/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorShire Pharmaceutical Development Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportShire Pharmaceutical Development Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire Pharmaceutical Development Ltd
    B.5.2Functional name of contact pointJoanna Perrette Hulme
    B.5.3 Address:
    B.5.3.1Street AddressHampshire International Business Park
    B.5.3.2Town/ cityChineham
    B.5.3.3Post codeRG24 8EP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441256894108
    B.5.6E-mailjperrett@shire.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 nameFosrenol Oral Powder 250mg
    D.3.2Product code SPD405
    D.3.4Pharmaceutical form Oral powder
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    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 RoleComparator
    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 Calcichew 500mg Chewable Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderShire Pharmaceuticals Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCalcichew 500mg Chewable Tablets
    D.3.2Product code SPD-406
    D.3.4Pharmaceutical form Chewable tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Treatment of Hyperphosphataemia.
    E.1.1.1Medical condition in easily understood language
    Hyperphosphataemia in chronic kidney disease is caused by decreased
    excretion of phosphorus by kidneys.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10020712
    E.1.2Term Hyperphosphatemia
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the percentage of subjects achieving age-specific Kidney
    Disease Outcomes Quality Initiative (KDOQI) targets for serum
    phosphorus in hyperphosphataemic children and adolescents with
    chronic kidney disease (CKD) on dialysis following treatment with
    calcium carbonate for 8 weeks and lanthanum carbonate for 8 weeks.
    E.2.2Secondary objectives of the trial
    Compare mean changes from baseline in hyperphosphataemic
    children/adolescents with CKD on dialysis following treatment with
    calcium carbonate for 8 weeks & lanthanum carbonate for 8 weeks.
    Describe pharmacokinetics (PK) of lanthanum carbonate in
    hyperphosphataemic children/adolescents aged 6 months to <18 years
    with CKD on dialysis after a single dose of lanthanum carbonate oral
    powder formulation is administered (Part 1).
    Investigate efficacy & safety of 12 months treatment with lanthanum
    carbonate in children/adolescents aged 6 months to <18 years (Part 2
    and 3).
    Investigate biochemical markers of bone metabolism in
    children/adolescents aged 6 months to <18 years with CKD on dialysis.
    Investigate growth in children/adolescents aged 6 months to <18 years
    with CKD on dialysis.
    Investigate safety profile in hyperphosphataemic children/adolescents
    with CKD on dialysis treated with calcium carbonate & lanthanum
    carbonate.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects 6 months to less than 18 years of age at the time of consent.
    2. Established on solid food, i.e., not exclusively on a liquid diet.
    3. Subject and parent or LAR understand and are able, willing, and likely
    to fully comply with the study procedures and restrictions defined in this
    protocol.
    4. Male, or non pregnant, non lactating female who agrees to comply
    with any applicable contraceptive requirements of the protocol.
    5. Established CKD on dialysis and requires treatment for
    hyperphosphataemia with a phosphate binder.
    6. Serum phosphorus levels after a washout period of up to 3 weeks:
    • Age <12 years: Serum phosphorus > 6.0mg/dL (1.94mmol/L).
    • Age 12 years and older: Serum phosphorus >5.5mg/dL
    (1.78mmol/L).
    7. Ability to provide written, signed, and dated (personally or via a
    legally acceptable representative) informed consent/and assent, as
    applicable, to participate in the study.
    E.4Principal exclusion criteria
    Subjects are excluded from the study if any of the following criteria are
    met:
    1. Current or recurrent disease (e.g., cardiovascular, liver, unstable and
    uncontrolled gastrointestinal (GI), malignancy, or other conditions)
    other than CKD or ESRD that could affect the action, absorption or
    disposition of the investigational product, or clinical or laboratory
    assessments.
    2. Current or relevant history of physical or psychiatric illness, any
    medical disorder (except for CKD or ESRD and related co-morbidities)
    that may require treatment or make the subject unlikely to fully
    complete the study, or any condition that presents undue risk from the
    investigational product or procedures.
    3. Unable to eat semi-solid foods or on Total Enteral Alimentation.
    4. Serum PTH > 700pg/mL.
    5. Serum calcium >10.2mg/dL (2.54mmol/L).
    6. Known or suspected intolerance or hypersensitivity to the
    investigational product(s), closely related compounds, or any of the
    stated ingredients.
    7. History of alcohol or other substance abuse within the last year.
    8. Current use of any medication (including over-the-counter (OTC),
    herbal, or homeopathic preparations) that could affect (improve or
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    worsen) the condition being studied, or could affect the action,
    absorption, or disposition of the investigational product(s), or clinical or
    laboratory assessment.
    9. Weight and age of subject are outside local applicable criteria for
    blood sample volume limits.
    10. Use of another investigational product within 30 days prior to
    receiving the first dose of investigational product.
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of subjects with serum phosphorus levels below the agespecific
    KDOQI targets following 8-weeks of treatment with calcium
    carbonate and lanthanum carbonate (Part 2 of the study).
    The KDOQI serum phosphorus targets are defined as:
    ‒ Adolescents aged ≥12-<18 years: ≤5.5mg/dL (1.78mmol/L).
    ‒ Children aged 6 months -<12 years: ≤6.0mg/dL (1.94mmol/L).
    The null hypothesis is that the difference in the percentages of subjects
    below the age-specific KDOQI targets following treatment with
    lanthanum carbonate and treatment with calcium carbonate is ≤-15%
    and the alternative hypothesis is that the difference in the corresponding
    percentages is >-15%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Part 2
    E.5.2Secondary end point(s)
    • Change from baseline in serum phosphorus, calcium and calciumphosphorus
    product levels at the last visit of each 8-week treatment
    period during Part 2 and monthly during the 10-month extension phase.
    • Biochemical bone markers: bone ALP, osteocalcin, TRAP, FGF-23, PTH,
    sclerostin and fetuin-A before and after each treatment period in Part 2,
    and at the end of Part 3 (Visits 2.0, 2.4, 2.8, and 3.9).
    • Height or length, head circumference and weight at each visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Part 3
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability.
    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 Yes
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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
    Argentina
    Chile
    Germany
    Hungary
    India
    Poland
    Russian Federation
    South Africa
    Turkey
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 100
    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: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 44
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 44
    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 are paediatrics.
    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 100
    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)
    As this is a non-inferiority study comparing lanthanum carbonate to the
    standard of care phosphate binder, it is envisaged that the subjects will
    revert back to the standard of care and there are no plans to provide
    the study medication after completion.
    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: Chile
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