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    Summary
    EudraCT Number:2011-005708-13
    Sponsor's Protocol Code Number:MICENAS-2011
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-05-16
    Trial 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 number2011-005708-13
    A.3Full title of the trial
    An open-label, randomized, parallel-group, multicenter, non-inferiority trial comparing the effectiveness and safety of an immuno-guided strategy versus a viremia-guided strategy for the prevention of cytomegalovirus infection in seropositive kidney transplant recipients.
    Ensayo clínico multicéntrico, aleatorizado, de grupos paralelos, abierto y de no inferioridad de comparación de la eficacia y seguridad de una estrategia inmunoguiada frente a una estrategia guiada por viremia en la profilaxis de la infección por citomegalovirus en receptores seropositivos de trasplante renal.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter clinical trial comparing the efficacy and safety of two strategies in the prevention of cytomegalovirus infection in kidney transplant recipients.
    Ensayo clínico multicéntrico de comparación de la eficacia y seguridad de dos estrategias en la prevención de la infección por citomegalovirus en trasplantados renales.
    A.4.1Sponsor's protocol code numberMICENAS-2011
    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 SponsorFundación para la Investigación Biomedica del Hospital 12 de Octubre
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Investigación Biomedica del Hospital 12 de Octubre
    B.5.2Functional name of contact pointUnidad Investigación Clínica y EECC
    B.5.3 Address:
    B.5.3.1Street AddressCentro Actividades Ambulatorias, bloque D, 6ª planta, Avda Córdoba, s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28041
    B.5.3.4CountrySpain
    B.5.4Telephone number3491779 26 35
    B.5.5Fax number3491390 85 44
    B.5.6E-mailensayosclinicos.uic@h12o.es
    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 Valcyte 450 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Farma, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameValcyte 450 mg
    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 INNVALGANCICLOVIR HYDROCHLORIDE
    D.3.9.1CAS number 175865-59-5
    D.3.9.4EV Substance CodeSUB16471MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number450
    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 Yes
    D.2.1.1.1Trade name Cymevene inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Farma, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCymevene inyectable
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGANCICLOVIR SODIUM
    D.3.9.1CAS number 107910-75-8
    D.3.9.4EV Substance CodeSUB02312MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Prophylaxis of cytomegalovirus infection in seropositive kidney transplant recipients.
    Profilaxis de la infección por citomegalovirus en receptores seropositivos de trasplante renal.
    E.1.1.1Medical condition in easily understood language
    Profilaxis of cytomegalovirus infection in kidney transplant recipients.
    Prevención de la infección por citomegalovirus en trasplantados renales.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate non-inferiority in terms of efficacy and safety (incidence of CMV disease over the first 6 months post-transplant) of a new strategy for prophylaxis against CMV inmunoguiada (based on systematic monitoring BMI) compared with the usual strategy of viremia guided prophylaxis (based on the early detection of viral replication and early treatment administration) in TR receivers intermediate risk (i.e. CMV seropositive at the time of transplantation (R) who have not received treatment depletor lymphocyte (ATG or muromonab)).
    Demostrar la no inferioridad en términos de eficacia y seguridad (incidencia de enfermedad por CMV a lo largo de los 6 primeros meses post-trasplante) de una nueva estrategia de profilaxis inmunoguiada frente al CMV (basada en la monitorización sistemática de la IMC) en comparación con la estrategia habitual de profilaxis guiada por viremia (basada en la detección precoz de la replicación viral y en la administración de tratamiento anticipado) en receptores de TR de riesgo intermedio (es decir, seropositivos frente a CMV en el momento del trasplante (R+) que no hayan recibido tratamiento con fármacos depletores linfocitarios (ATG o muromonab)).
    E.2.2Secondary objectives of the trial
    a) To compare the reliability and accuracy of different strategies of monitoring of the CMI response against CMV in the context of a strategy of immuno-guided prophylaxis in intermediate-risk KT recipients.
    b) demonstrate the decrease in the number of episodes of asymptomatic CMV viremia and the total duration of the period of viral replication "permissive" (ie, low level and without direct clinical impact).
    c) To demonstrate a decrease in the incidence of indirect effects attributable to CMV infection.
    d) To demonstrate a decrease in the number of prescriptions and the duration of antiviral drugs use and the number of hospitalization episodes in those KT recipients undergoing a strategy of immunoguided prophylaxis against CMV, as compared to those undergoing a conventional strategy of viremia-guided prophylaxis.
    e) To demonstrate a decrease in the incidence of adverse effects associated to such treatment in those KT recipients.
    a) Comparar la utilidad y precisión de varias técnicas de monitorización de la IMC en el contexto de una estrategia de profilaxis inmunoguiada frente a CMV en receptores de TR de riesgo intermedio.
    b) Demostrar la disminución en el nº de episodios de viremia asintomática por CMV y la duración total de dicho periodo de replicación viral "permisiva" (es decir, de bajo nivel y sin repercusión clínica directa).
    c) Demostrar un descenso enla incidencia de los efectos indirectos atribuibles a la infección por CMV.
    d) Demostrar la disminución en el nº de prescripciones y en la duración del tratamiento antiviral y del número de episodios de hospitalización en los receptores de TR sometidos a una estrategia de profilaxis inmunoguiada frente a CMV, en comparación con la estrategia convencional de profilaxis guiada por viremia.
    e) Demostrar la disminución en la incidencia de acontecimientos adversos atribuibles a dicho tratamiento antiviral en los receptores de TR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participant is aged 18 years or older.
    -Participant is willing and able to give informed consent (IC) for participation in the study.
    -Presence of end-stage renal disease (ESRD) of any cause undergoing KT regardless of donor type (live, heart-beating or non-heart-beating).
    - Recipient of intermediate risk, ie, seropositive for CMV (R +) (presence of a positive serology for CMV in the pre-transplant evaluation (performed at least 6 months prior to inclusion in the study) and not subject to any depletor treatment of lymphocytes.
    - Edad del participante mayor de 18 años.
    - Capacidad para otorgar el consentimiento informado (CI) para la participación en el estudio.
    - Insuficiencia renal crónica de cualquiere etiología sometida a trasplante renal durante el periodo de reclutamiento del estudio, independientemente del tipo de donante (muerte encefálica, asistolia o vivo).
    - Receptor de riesgo intermedio, es decir, seropositivo para CMV (R+) (presencia de una serología positiva para CMV en la evaluación pre-trasplante (realizada al menos en los 6 meses previos a la inclusión en el estudio) y no sometido a ningún tratamiento depletor de linfocitos.
    E.4Principal exclusion criteria
    The participant may not enter the study if ANY of the following apply:
    - Inability or unwillingness of individual or legal guardian/representative to give written IC for participation in the study.
    - Formal contraindication for receiving antiviral drugs (ganciclovir or valganciclovir): pregnancy or use of unreliable birth control methods; breastfeeding; preexisting or sustained neutropenia (<0.50 x 109 cells/L); creatinine clearance (CrCl) <10 mL/min; or known hypersensitivity to GCV, VGCV or aciclovir.
    - Participant undergoing a simultaneous double SOT (pancreas-kidney or liver-kidney).
    - Participant who has underwent a previous SOT or allo-HSCT.
    - Administration of induction therapy after transplantation with lymphocyte-depleting drugs (ATG or anti-CD3 monoclonal antibodies [muromonab]).
    - Infection by the human immunodeficiency virus (HIV), as assessed by serologic testing in the pre-transplant evaluation (performed at least within 6 months prior to study entry).
    - Participation in another clinical drug trial.
    Ningún sujeto podrá entrar en el estudio si cumple alguno de los siguientes criterios:
    - Incapacidad o denegación del paciente (o de su representante legal) para otorgar su CI para la participación en el estudio.
    -Contraindicación formal para la administración de fármacos antivirales (ganciclovir o valganciclovir): embarazo o empleo de métodos anticonceptivos no seguros, lactancia materna, neutropenia previa o mantenida (<0,5 x 109 céls/L); aclaramiento de creatinina <10 mL/min o historia documentada de hipersensibilidad a GCV, VGCV o aciclovir.
    - Receptores de un doble trasplante (pancreato-renal o hepato-renal).
    - Receptores de TOS o alo-TPH previos.
    - Administración de tratamiento de inducción post-trasplante mediante fármacos depletores de linfocitos (ATG o anticuerpos monoclonales anti-CD3 [muromonab]).
    - Diagnóstico de infección por el virus de la inmunodeficiencia humana (VIH) confirmado serológicamente en la evaluación pre-trasplante (al menos 6 meses antes de la entrada en el estudio).
    - Participación simultánea del paciente en otro EC.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of CMV disease (defined according to the criteria proposed by Ljungman et al) during the first 6 months post-transplant [number of episodes of CMV disease per 100 recipients and per 1,000 transplant-days].
    Incidencia de enfermedad por CMV (definida según los criterios establecidos en la literatura por Ljungman et al) a lo largo de los 6 primeros meses post-trasplante [número de episodios de enfermedad por CMV por cada 100 receptores y por cada 1.000 días-trasplante].
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 months
    A los 6 meses
    E.5.2Secondary end point(s)
    -Incidence of CMV viremia during the first 6 months post-transplant [number of episodes of CMV viremia per 100 recipients and per 1,000 transplant-days].
    -Incidence of other non-CMV opportunistic infections during the first 6 months post-transplant [number of episodes of opportunistic infection per 100 recipients and per 1,000 transplant-days].
    -Incidence of acute rejection during the first 6 months post-transplant [number of episodes of acute rejection per 100 recipients and per 1,000 transplant-days].
    -Number of prescriptions of antiviral drugs (either GCV or VGCV) and total duration of antiviral treatment during the first 6 months post-transplant [number of defined daily doses (DDD) per 1,000 transplant-days].
    -Incidence of adverse events attributable to the antiviral therapy: new-onset leukopenia, neutropenia, or thrombocytopenia in the course of ganciclovir or valganclovir administration, with no alternative diagnosis during the first 6 months post-transplant [number of events per 100 recipients and per 1,000 transplant-days].
    -Requirements for any cause hospitalization, hospitalization due to CMV-related clinic event, and hospitalization for administration to administer antiviral treatment during the first 6 months post-transplant [number of hospitalization days per 100 recipients].
    -Incidencia de viremia por CMV a lo largo de los 6 primeros meses post-trasplante [número de episodios de viremia por CMV por cada 100 receptores y por cada 1000 días-trasplante].
    -Incidencia de otras infecciones oportunistas no causadas por CMV a lo largo de los 6 primeros meses post-trasplante [número de episodios por cada 100 receptores y por cada 1000 días-trasplante].
    -Incidencia de rechazo agudo del injerto a lo largo de los 6 primeros meses post-trasplante [número de episodios de rechazo por cada 100 receptores y por cada 1.000 días-trasplante].
    -Número de prescripciones de medicamentos antivirales (GCV o VGCV) y duración total del tratamiento antiviral durante los primeros 6 meses post-trasplante [nº de dosis diarias definidas (DDD) por 1.000 días-trasplantes].
    -Incidencia de acontecimientos adversos atribuibles al tratamiento antiviral: aparición de leucopenia, neutropenia, trombocitopenia en el curso del tratamiento con GCV o VGCV, en ausencia de causa alternativa, a lo largo de los 6 primeros meses post-trasplante [nº de eventos por cada 100 receptores y por cada 1.000 días-trasplante].
    -Necesidad de hospitalización por cualquier causa, hospitalización debida a un evento relacionado con la infección por CMV, y hospitalización para la administración del tratamiento antiviral a lo largo de los 6 primeros meses post-trasplante [nº de días de hospitalización por cada 100 receptores].
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 6 months
    A los 6 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    2 estrategias diferentes de profilaxis frente al CMV en TR
    Two strategies for the prevention of CMV infection in KT recipients
    E.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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.1.2.1Number of subjects for this age range: 354
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 354
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state354
    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
    No aplica
    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 Decision2013-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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