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    Summary
    EudraCT Number:2006-003330-15
    Sponsor's Protocol Code Number:MCI-196-E10
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-31
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2006-003330-15
    A.3Full title of the trial
    Estudio de fase III, multicéntrico y abierto sobre la seguridad a largo plazo de MCI-196 con dosis flexible en sujetos en diálisis con insuficiencia renal crónica en estadio V con hiperfosfatemia (incorporando una comparación con sevelamer)
    A.4.1Sponsor's protocol code numberMCI-196-E10
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMitsubishi Pharma Corporation
    B.1.3.4CountryJapan
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 CHOLEBINE®
    D.2.1.1.2Name of the Marketing Authorisation holderMitsubishi Pharma Corporation
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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.3.2Product code MCI-196
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNcolestilan
    D.3.9.1CAS number 95522-45-5
    D.3.9.2Current sponsor codeMCI-196
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Renagel®
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme 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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNSevelamer
    D.3.9.1CAS number 52757-95-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Hiperfosfatemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10020711
    E.1.2Term Hyperphosphataemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Averiguar el perfil de seguriad y tolerabilidad a largo plazo del MCI-196 en sujetos en diálisis con IRC e hiperfosfatemia.
    E.2.2Secondary objectives of the trial
    - Evaluar la eficacia a largo plazo de dosis flexibles de MCI-196.
    - Evaluar la eficacia y seguridad a largo plazo de MCI-196 y sevelamer.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. El sujeto es capaz de leer y comprender la hoja de información al paciente y cumplir con los requisitos del estudio y otorga un consentimiento informado por escrito.
    2. El sujeto es varón o mujer de 18 a 80 años de edad.
    3. El sujeto tiene un diagnóstico de IRC (estadio V) definida de acuerdo con la guía del K/díaOQI (es decir, TFG <15 ml/min/1,73m2 o diálisis).
    4. El sujeto está clínicamente estable con la hemodiálisis o diálisis peritoneal durante al menos 3 meses, determinado así por el investigador.
    5. El sujeto se somete a diálisis regularmente:
    - Si el sujeto está en hemodiálisis, ésta está programada 3 veces por semana en un hospital o centro clínico. La duración debe ser de 3 a 5 horas o un mínimo de 2,5 horas para la diálisis de alto flujo, dependiendo de la atención estándar de cada centro.
    - Si el sujeto se somete a diálisis peritoneal, la DPA (diálisis peritoneal automatizada) debe ser diaria y la DPAC (diálisis peritoneal ambulatoria continua) debe suponer al menos tres cambios de bolsa al día.
    6. El sujeto tiene un contenido de calcio en el dializado entre 1 y 1,75 mmol/l (de 2 a 3,5 mEq/l), dependiendo del estándar de cada centro. El contenido de calcio en el dializado debe permanecer constante durante todo el estudio.
    7. El sujeto sigue una dieta estabilizada de fósforo, que el médico considera adecuada.
    8. El sujeto tiene un Kt/V basal (single pool) de al menos 1,2 para los sujetos en hemodiálisis y un valor de Kt/V semanal de al menos 1,8 para los sujetos en diálisis peritoneal.
    9. En el caso de las mujeres en edad de concebir, el test de embarazo en plasma es negativo. Las mujeres con vida sexual activa deben aceptar tomar las medidas necesarias para no quedarse embarazadas durante la duración del estudio clínico. En concreto, para participar en el estudio, las mujeres con vida sexual activa deben llevar al menos 2 años de menopausia, estar esterilizadas quirúrgicamente o utilizar una forma aceptada de anticoncepción (anticonceptivos orales durante al menos 3 meses o un dispositivo intrauterino durante al menos 2 meses antes del inicio de la visita de evaluación o varios métodos de barrera, p. ej. diafragma o condón con espermicida).
    10. Los sujetos varones deben aceptar utilizar una anticoncepción apropiada durante la duración del estudio clínico.
    11. Si el sujeto participó previamente en el estudio E07 e inicialmente recibió sevelamer, ha completado las 12 semanas de tratamiento del estudio.
    12. Si el sujeto participó previamente en el estudio E07 e inicialmente recibió MCI-196 o placebo, entonces ha completado las 16 semanas de tratamiento del estudio.
    13. Si el sujeto participó previamente en el estudio E08, ha completado las 12 semanas de tratamiento del estudio.
    14. Si el sujeto participó previamente en el estudio E09, ha completado las 12 semanas de tratamiento del estudio.
    E.4Principal exclusion criteria
    1. El sujeto padece otras enfermedades concomitantes, que pudieran comprometer sustancialmente su seguridad o exponerle a un riesgo innecesario o interferir significativamente con los procedimientos del estudio y que, a juicio del investigador, convierten al sujeto en inapropiado para ser incluido en el estudio.
    2. El sujeto tiene una concentración sérica de albúmina <30,0 g/l.
    3. El sujeto tiene una concentración de PTH >1000 pg/dl.
    4. El sujeto tiene un índice de masa corporal (IMC) £16,0 kg/m2 o >40,0 kg/m2.
    5. El sujeto padece actualmente o tiene antecedentes de problemas significativos de motilidad gastrointestinal (GI), como disfagia o dificultades de deglución, o alteraciones GI como estreñimiento crónico o grave, colitis sigmoidea, úlceras o cirugía GI mayor.
    6. El sujeto presenta obstrucción biliar o disfunción hepática demostrada, p. ej. hepatitis, cirrosis, síndrome hepatorrenal o los resultados de las pruebas de función hepática son 3 veces mayores a los valores normales en al menos 2 de los parámetros (ALT; AST, fosfatasa alcalina y gamma-glutamil-transferasa).
    7. El sujeto ha dado positivo en las pruebas de antígeno de superficie de la hepatitis B, anticuerpos de la hepatitis C o anticuerpos del VIH 1 y 2.
    8. El sujeto tiene antecedentes de abuso de sustancias o de alcohol en el último año.
    9. El sujeto tiene crisis epilépticas.
    10. El sujeto tiene antecedentes de alergia a fármacos o a otras sustancias que contraindica su participación.
    11. El sujeto está tomando alguno de los siguientes fármacos:
    - Colesevelam, colestiramina o colestipol
    12. El sujeto tiene un catéter temporal como acceso vascular.
    13. El sujeto ha participado en un ensayo clínico con medicación experimental (con la excepción de los estudios MCI-196 E07, E08 y E09) en los últimos 30 días o con un producto biológico experimental en los 90 días anteriores a la firma del consentimiento informado.
    14. Si está en diálisis peritoneal, el sujeto tiene antecedentes recientes de peritonitis (en los 3 meses previos).
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal del estudio es la variación desde el momento inicial (es decir, el inicio del estudio previo) hasta el momento final de los parámetros de seguridad (p. ej., constantes vitales y valores de laboratorio).
    En el caso del estudio E10, el momento final se define como la semana 40 o, al igual que en cualquier estudio, la "última observación" si la participación del sujeto ha cesado prematuramente.
    De este modo, se prevé que la mayoría de los sujetos seleccionados para el estudio E10 tendrán la oportunidad de estar expuestos al MCI-196 o al sevelamer durante 52 semanas en total.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    dosis flexible
    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.8.3 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 EEA37
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-01-31. Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 800
    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)
    Tratamiento normal para esta indicación
    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 Decision2007-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-08-06
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