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    Summary
    EudraCT Number:2008-003241-89
    Sponsor's Protocol Code Number:LCP-Tacro-3002
    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:2010-11-25
    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 number2008-003241-89
    A.3Full title of the trial
    Estudio de fase 3, doble ciego y con doble simulación, multicéntrico, prospectivo, aleatorizado, sobre la eficacia y la seguridad de LCP-Tacro^TM comprimidos, una vez al día, en comparación con Prograf® cápsulas, dos veces al día, en combinación con micofenolato mofetilo para la prevención del rechazo agudo de aloinjertos en receptores adultos de trasplantes de riñón de novo.

    A Phase 3, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study of the Efficacy and Safety of LCP-Tacro^TM Tablets, Once Daily, Compared to Prograf® Capsules, Twice Daily, in Combination with Mycophenolate Mofetil for the Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients.
    A.4.1Sponsor's protocol code numberLCP-Tacro-3002
    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 SponsorLifeCycle Pharma A/S
    B.1.3.4CountryDenmark
    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 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 nameLCP-Tacro 0,75 mg comprimido
    D.3.4Pharmaceutical form 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 INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.9.3Other descriptive nameFujimycin; L 679934; MLD 987; Tsukubaenolide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 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 nameLCP-Tacro 1,0 mg comprimido
    D.3.4Pharmaceutical form 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 INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.9.3Other descriptive nameFujimycin; L 679934; MLD 987;Tsukubaenolide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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: 3
    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 nameLCP-Tacro 4,0 mg comprimido
    D.3.4Pharmaceutical form 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 INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.9.3Other descriptive nameFujimycin; L 679934; MLD 987; Tsukubaenolide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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: 4
    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 Prograf 0.5mg Hard Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma 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 namePrograf 0,5 mg cápsula
    D.3.4Pharmaceutical form Capsule, hard
    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 INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.9.3Other descriptive nameFujimycin; L 679934; MLD 987; Tsukubaenolide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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: 5
    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 Prograf 1 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma 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 namePrograf 1,0 mg Cápsula
    D.3.4Pharmaceutical form Capsule, hard
    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 INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.9.3Other descriptive nameFujimycin; L 679934; MLD 987; Tsukubaenolide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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: 6
    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 Prograf 5 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma 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 namePrograf 5,0 mg Cápsula
    D.3.4Pharmaceutical form Capsule*
    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 INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.9.3Other descriptive nameFujimycin; L 679934; MLD 987; Tsukubaenolide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevención del rechazo agudo de aloinjertos en receptores adultos de trasplantes de riñón de novo.

    Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10050436
    E.1.2Term Prophylaxis against renal transplant rejection
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia y la seguridad de LCP-Tacro (tacrolimus) comprimidos administrado una vez al día en comparación con Prograf (tacrolimus) cápsulas dos veces al día como tratamiento inmunosupresor para la prevención del rechazo agudo de aloinjertos en receptores adultos de un trasplante de riñón de novo tratados durante un período de tratamiento de 12 meses seguido de un período de tratamiento de extensión enmascarado de 12 meses.
    Demostrar que LCP-Tacro comprimidos no es clínicamente inferior a Prograf cápsulas en la prevención del rechazo agudo de aloinjertos en receptores adultos de un trasplante de riñón de novo.
    E.2.2Secondary objectives of the trial
    No aplica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Consentimiento informado firmado.
    2. Entre 18 y 70 años de edad, inclusive.
    3. Los pacientes deben haber recibido un aloinjerto renal primario o secundario procedente de un donante fallecido o de un donante vivo con HLA (antígeno leucocítico humano) no idéntico.
    4. Los pacientes no deben tener contraindicaciones conocidas para la administración de tratamiento de inducción con antagonistas de los receptores de IL-2, MMF, corticosteroides o tacrolimus.
    5. Las mujeres en edad fértil deben tener una prueba de embarazo negativa (prueba de embarazo en suero o en orina con una sensibilidad de al menos 25 mUI/ml) en la semana previa al comienzo del tratamiento. Las mujeres en edad fértil deberán estar dispuestas a utilizar métodos anticonceptivos según se detalla en las directrices de anticoncepción.
    6. Prueba de compatibilidad cruzada negativa y tipo de sangre compatible (A, B, AB o O).
    7.Capacidad de tragar los comprimidos y cápsulas.
    E.4Principal exclusion criteria
    1. Receptores de algún trasplante no renal (órgano sólido o médula ósea) en alguna ocasión.
    2. Anticuerpos reactivos (AR) > 30 %.
    3. Pacientes con cualquier trastorno que pueda afectar a la absorción del fármaco del estudio (por ejemplo, gastrectomía o gastroenteropatía diabética clínicamente significativa).
    4. Índice de masa corporal (IMC) < 18 kg/m^2 o > 40 kg/m^2, calculado mediante la fórmula IMC = peso/(estatura^2).
    5. Antecedentes de alcoholismo con menos de 6 meses de abstinencia.
    6. Antecedentes de toxicomanías con menos de 6 meses de abstinencia documentada.
    7. ECG de 12 derivaciones de selección que muestre anomalías clínicamente significativas (como una prolongación del intervalo QTc, isquemia reversible e insuficiencia cardíaca congestiva clínicamente sintomática o fracción de eyección documentada inferior al 45 %).
    8. Las mujeres en edad fértil que estén embarazadas o en período de lactancia, que tengan previsto quedarse embarazadas o que tengan una prueba de embarazo en suero o en orina positiva.
    9. Pacientes con una temperatura oral (antes de la administración del fármaco del estudio) igual o superior a 38,0 °C.
    10. Pacientes con infecciones activas clínicamente significativas (por ejemplo, que requieren hospitalización o conforme al criterio del investigador), tales como tuberculosis activa, latente o previa.
    11. Pacientes con inmunodeficiencia hereditaria conocida.
    12. Pacientes con neoplasias malignas o con antecedentes de neoplasias malignas (en los últimos cinco años) salvo neoplasias locales, no invasivas, completamente extirpadas: carcinoma basocelular cutáneo, carcinoma espinocelular cutáneo o carcinoma de cuello uterino in situ.
    13. Pacientes que estén recibiendo o que esperen recibir sirolimus, everolimus, azatioprina o ciclofosfamida en los 3 meses anteriores al reclutamiento.
    14. Pacientes con signos de una enfermedad clínicamente significativa (p. ej., enfermedad cardíaca, digestiva o hepática) que aumente el riesgo para el paciente de la participación en el ensayo o que genere confusión en los resultados del estudio.
    15. Pacientes con isquemia cardíaca reversible (antecedentes de isquemia reversible no tratada en la prueba de esfuerzo).
    16. Pacientes con insuficiencia cardíaca congestiva clínicamente significativa o fracción de eyección documentada inferior al 45 %.
    17. Pacientes con enfermedad pulmonar obstructiva crónica significativa, enfermedad pulmonar restrictiva o hipertensión pulmonar significativa.
    18. Tratamiento con un fármaco, dispositivo o pauta en investigación en el año anterior a la primera dosis del fármaco del estudio.
    19. Pacientes que no estén dispuestos a abstenerse de consumir pomelo o zumos que contengan pomelo durante el período del estudio.
    20. Pacientes que estén recibiendo medicamentos concomitantes que puedan afectar a las concentraciones de tacrolimus en sangre, según se indica en el anexo 2.
    21. Variables de laboratorio con anomalías (fuera del intervalo de referencia del laboratorio) clínicamente significativas, según el criterio del investigador.
    22. Pacientes con resultados positivos en cualquiera de las pruebas serológicas siguientes: anticuerpos contra el virus de la inmunodeficiencia humana (VIH) de tipo 1, antígeno de superficie (HBsAg) del virus de la hepatitis B (VHB), anticuerpos contra el antígeno central del virus de la hepatitis B (HBcAb) y anticuerpos contra el virus de la hepatitis C (VHC) (Ac VHC). Los resultados negativos en estas pruebas serológicas deben estar documentados en los 12 meses previos a la aleatorización.
    23. Pacientes que experimenten pérdida del injerto en el año siguiente al trasplante, por rechazo agudo o por nefropatía por el VBK.
    24. Pacientes que hayan padecido glomeruloesclerosis segmentaria focal (GSF).
    25. Donante con un resultado positivo en las pruebas serológicas para el VIH-1, VHB o VHC.
    26. Donante con antecedentes de neoplasia maligna (actual o antigua).
    27. Donante de alto riesgo conforme a los criterios de los Centros para el Control y la Prevención de Enfermedades
    28. Pacientes con disfunción mental o incapacidad para cooperar con el estudio.
    29. Tiempo de isquemia en frío > 30 horas.
    30. Donante fallecido.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal de la eficacia es la incidencia de fracasos del tratamiento 12 meses después de la aleatorización de los sujetos para recibir la medicación del estudio. El fracaso del tratamiento es un criterio de valoración compuesto que incluirá la aparición en cualquier paciente de los siguientes acontecimientos: muerte, pérdida del injerto, rechazo agudo demostrado por biopsia (RADB; grado de Banff > ó = 1a) o pérdida del contacto durante el seguimiento.

    Los criterios principales de valoración de la seguridad en el mes 12 (día 360) serán:
    1. Incidencia de acontecimientos adversos, acontecimientos adversos graves y retiradas por acontecimientos adversos.
    2. Incidencia de las siguientes anomalías analíticas predefinidas que pueden ser clínicamente significativas:
    - GA > ó = 126 mg/dl
    - plaquetas < 100 x 10^9 células/l
    - leucocitos < 2,0 x 10^9 células/l
    - transaminasas > ó = 100 U/l
    - colesterol total > ó = 240 mg/dl
    - colesterol de las LDL > ó = 190 mg/dl
    - triglicéridos > ó = 200 mg/dl
    - IFGe < 30 ml/min
    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 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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    Doble simulación
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Yes
    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
    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
    E.8.9.2In all countries concerned by the trial years3
    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 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 540
    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 Decision2011-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
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