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    The EU Clinical Trials Register currently displays   42517   clinical trials with a EudraCT protocol, of which   7000   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-000171-17
    Sponsor's Protocol Code Number:SPD405-207
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-09
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2012-000171-17
    A.3Full title of the trial
    A 3-part Open-label Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Compare the Efficacy, Safety and Tolerability of 8 Weeks of Treatment With Lanthanum Carbonate and Calcium Carbonate using a Crossover design and Investigate the Efficacy and Safety of 8 Months of Treatment With Lanthanum Carbonate in Hyperphosphataemic Children and Adolescents Aged 10 years to <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/232/2016
    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
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressAvenida del Partenón 18, 4º planta,
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number441423850717
    B.5.6E-mailMedinfoEMEA@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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLANTHANUM CARBONATE
    D.3.9.1CAS number 54451-24-0
    D.3.9.2Current sponsor codeSPD405-207
    D.3.9.3Other descriptive nameLANTHANUM CARBONATE
    D.3.9.4EV Substance CodeSUB21835
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 20.1
    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 summarize the percentage of subjects achieving age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on dialysis, following 8 weeks of treatment with lanthanum carbonate
    E.2.2Secondary objectives of the trial
    1. To investigate the safety profile in hyperphosphatemic children and adolescents with CKD on dialysis treated with calcium carbonate and/or lanthanum carbonate.
    2. To summarize the percentage of subjects achieving KDOQI targets for serum phosphorus in hyperphosphatemic children and adolescents with CKD who are on dialysis following treatment with calcium carbonate for 8 weeks and lanthanum carbonate for 8 weeks.
    3. To assess mean changes from baseline in serum phosphorus, calcium and calcium-phosphorus product in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks.
    4. To summarize mean changes from baseline in serum phosphorus, calcium and calcium-phosphorus product in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate for 8 weeks and lanthanum carbonate for 8 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject cannot be enrolled in the study before all of the following inclusion criteria(including test results) are met.
    1.Aged 10 years to <18 years of age at the time of consent.
    2. Subject or parent/legally authorised representative (LAR) understand and are able,willing, and likely to fully comply with the study procedures and restrictions defined in this protocol.
    3.Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.
    4. Established CKD, on dialysis, and requires treatment for hyperphosphataemia with a phosphate binder.
    5. Serum phosphorus levels after a washout period of up to 3 weeks as follows:
    - Age <12 years: Serum phosphorus >6.0mg/dL (1.94mmol/L)
    - Age 12 years and older: Serum phosphorus >5.5mg/dL (1.78mmol/L)
    6. Ability to provide written, signed and dated (personally or via an LAR) informed consent/and assent, as applicable, to participate in the study.
    E.4Principal exclusion criteria
    1. Current or recurrent disease (eg, cardiovascular, liver, unstable and uncontrolled gastrointestinal, malignancy, or other conditions) other than CKD or end-stage renal disease 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 end-stage renal disease 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. Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
    5. History of alcohol or other substance abuse within the last year.
    6. Current use of any medication (including over-the-counter, herbal, or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action, absorption, or disposition of the investigational product(s), or clinical or laboratory assessment.
    7. Weight and age of subject are outside of local applicable criteria for blood sample volumelimits.
    8. 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 achieving age-specific KDOQI targets for serum phosphate level following 8-weeks of treatment with lanthanum carbonate The KDOQI serum phosphorus targets are defined as:
    - Adolescents aged ≥12-18 years: ≤5.5mg/dL (1.78mmol/L)
    - Children aged 10 years <12 years: ≤6.0mg/dL (1.94mmol/L)
    For the primary endpoint, the percentage of subjects achieving age-specific KDOQI targets for serum phosphate levels after 8 weeks of lanthanum carbonate treatment will be descriptively summarized and calculated along with a 95% confidence interval. The FAS and PP2 Sets will be used for this descriptive summarization. Serum phosphate levels tested at a central laboratory will be used for the analysis. In the case of missing central laboratory data, local laboratory data will be used.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Part 2
    E.5.2Secondary end point(s)
    • The percentage of subjects with serum phosphorus levels below the age-specific KDOQI targets following 8 weeks of treatment with calcium carbonate followed by 8 weeks of treatment with lanthanum carbonate will be descriptively summarized and will be calculated along with a 95% confidence interval, separately, for each treatment arm. The FAS and PP1 Sets will be used for this summarization. The KDOQI serum phosphorus targets are defined as:
    - Adolescents aged ≥12-<18 years: ≤5.5mg/dL (1.78mmol/L)
    - Children aged 10 years -<12 years: ≤6.0mg/dL (1.94mmol/L)
    • Changes from baseline in serum phosphorus, calcium and calcium-phosphorus product in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks.
    • Change from baseline in serum phosphorus, calcium and calcium-phosphorus product levels at the last visit of each 8 week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3).
    • 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.

    • Height and weight at:
    o Visits 2.0, 2.4, 2.8, and 3.5 (Parts 2a and 3)
    o Visits 1.0, 2.4, and 3.5 (Parts 2b and 3).


    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Argentina
    Bulgaria
    Chile
    Czech Republic
    Germany
    Hungary
    Poland
    Romania
    Russian Federation
    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.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months4
    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: 65
    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: 15
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 65
    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)
    Not applicable
    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 Decision2014-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-16
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