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    Summary
    EudraCT Number:2015-002812-33
    Sponsor's Protocol Code Number:204824
    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:2016-10-25
    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 number2015-002812-33
    A.3Full title of the trial
    A Phase 2 Pilot, Multicenter, Single Arm Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GSK1070806 plus Standard of Care for the Prevention of Delayed Graft Function in Adult Subjects After Renal Transplantation
    Estudio piloto de fase 2, multicéntrico, con un solo grupo, para evaluar la eficacia, seguridad, tolerabilidad y farmacocinética de GSK1070806 añadido al tratamiento habitual para la prevención de la función retrasada del injerto en adultos después de un trasplante renal.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to understand whether GSK1070806 improves renal transplant function immediately and in the long term after transplantation
    Ensayo para entender si GSK1070806 mejora la función renal tras el trasplante a corto y largo plazo.
    A.4.1Sponsor's protocol code number204824
    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 SponsorGlaxoSmithKline, S.A.
    B.1.3.4CountrySpain
    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 supportGlaxoSmithKline R&D Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointCentro de Información
    B.5.3 Address:
    B.5.3.1Street AddressC/Severo Ochoa, 2 (P.T.M.)
    B.5.3.2Town/ cityTres Cantos (Madrid)
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number34902202700
    B.5.5Fax number34918070479
    B.5.6E-mailes-ci@gsk.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 nameGSK1070806
    D.3.2Product code GSK1070806
    D.3.4Pharmaceutical form 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 INNAnti-Interleukin 18
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeGSK1070806
    D.3.9.3Other descriptive nameGSK1070806
    D.3.9.4EV Substance CodeSUB31851
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) 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) Yes
    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
    Delayed Graft Function in Adult Subjects After Renal Transplantation.
    Función retrasada del injerto en adultos después de un trasplante renal.
    E.1.1.1Medical condition in easily understood language
    Delayed Graft Function (DGF) following renal transplantation.
    Retraso de la función renal (RFI) después del trasplante renal
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level HLT
    E.1.2Classification code 10074474
    E.1.2Term Transplantation complications
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the frequency of delayed graft function (DGF) in donation after circulatory death (DCD) renal transplant recipients treated with GSK1070806.
    Determinar la frecuencia de retraso a la función del injerto (RFI) en receptores de trasplante renal con donación tras la muerte por criterios circulatorios (DMC) tratados con GSK1070806.
    E.2.2Secondary objectives of the trial
    - To assess graft function in DCD renal transplant recipients treated with GSK1070806.
    - To assess the effect of GSK1070806 on acute rejection risk, and rejection/PD biomarkers.
    - To assess the effect of GSK1070806 on dialysis dependency and graft survival.
    - To assess the safety and tolerability of GSK1070806 in renal transplant recipients.
    - To assess the pharmacokinetics of GSK1070806 in renal transplant recipients.
    - To assess the effect of GSK1070806 administration on serum IL-18 levels.
    - To determine immunogenicity of GSK1070806 in renal transplant recipients.
    - Evaluar la función del injerto en receptores de trasplante renal con DMC tratados con GSK1070806.
    - Evaluar el efecto de GSK1070806 en el riesgo de rechazo agudo y los biomarcadores del rechazo/FD.
    - Evaluar el efecto de GSK1070806 en la dependencia de la diálisis y la supervivencia del injerto.
    - Evaluar la seguridad y tolerabilidad de GSK1070806 en receptores de trasplante renal.
    - Evaluar la farmacocinética de GSK1070806 en receptores de trasplante renal.
    - Evaluar el efecto de la administración de GSK1070806 en la concentración sérica de IL-18.
    - Determinar la inmunogenicidad de GSK1070806 en receptores de trasplante renal.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    TITLE: Investigating the role of interleukin 18 in ischemia re-perfusion injury in human kidneys.
    Date: 30th Nov 2015 Version 00
    This substudy will run concurrently with 204824
    •Objectives
    To understand the responses of peripheral blood mononuclear cells (PBMCs) to ischemia reperfusion injury in the transplanted kidney
    To understand how PBMC responses are altered by neutralization of IL-18 cytokine
    To understand how IL-18 cytokine neutralization affects fibrosis of the transplanted kidney
    Título: investigación del papel de IL-18 en el daño isquémico de reperfusión en riñón humano. Fecha 30-Nov-2015 V0. Subestudio que se realiza concurrentemente con 204824 en centro específico (Cambridge)
    Objetivos:
    Conocer las respuestas de las células mononucleares de sangre periferica al daño por isquemia en el trasplante de riñón
    Entender como las células momonucleares de sangre periférica se alteran por la neutralización de la citoquina IL-18
    Comprender cómo la neutralización de la citoquina IL-18 afecta a la fibrosis del riñón trasplantado
    E.3Principal inclusion criteria
    1. Recipient age range: 18 years of age and older, at the time of signing the informed consent.
    2. Dialysis-dependent recipient of first time or second time, single kidney-only, Donation after Circulatory Death (DCD) transplant.
    -Donor kidney must be ‘controlled’ meeting either Maastricht Category 3 or 4 criteria:
    Category 3: Donor awaiting cardiac arrest
    Category 4: Cardiac arrest in a brain stem dead donor
    3. Eligible for kidney transplantation: Considered eligible for transplantation after undergoing multidisciplinary evaluation at the institution at which the transplantation will be performed.
    4. Immunosuppressants (at the time of transplantation): planned to receive a combination of immunosuppressants including basiliximab, mycophenolate mofetil or azathioprine, tacrolimus, and corticosteroids.
    5. Male and Female:
    Males: Male subjects with female partners of child bearing potential must utilize a condom and female partners must comply with use of one of the highly effective contraceptive methods described in Appendix 4 of the protocol for 180 days post-dose of study medication.
    Females:
    a. Non-reproductive potential defined as:
    • Females with one of the following procedures documented and no plans to utilize assisted reproductive techniques (e.g., in vitro fertilization or donor embryo transfer):
    - Bilateral tubal ligation or salpingectomy
    - Hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
    - Hysterectomy
    - Bilateral Oophorectomy (surgical menopause)
    • Postmenopausal defined as 12 months of spontaneous amenorrhea.
    - In questionable cases (including cases in which amenorrhea is suspected to result from a subject’s poor renal function/dialysis) a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause are required. If FSH/estradiol results are not available in time subjects are to be initiated on contraceptive methods (see below and Appendix 4 of the protocol).
    - Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study.
    b. Reproductive potential. Must not be pregnant or lactating, and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (see Appendix 4 of the protocol) for 180 days post dose. If a hormonal method of birth control is selected from the list in Appendix 4 of the protocol, then subjects must have been using these methods at least 28 days prior to GSK1070806 administration, or be abstinent, or utilize a condom as a method of contraception until the selected hormonal method has been in place for the 28 day period.
    The investigator is responsible for ensuring that subjects understand how to properly use the indicated methods of contraception by providing counsel directly or by referring subjects to health care professionals with expertise in this area.
    6. Capable of providing signed informed consent as described in Section 10.2 which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
    1. Intervalo de edades de los receptores: 18 o más años de edad en el momento de firmar el consentimiento informado.
    2. Receptor dependiente de diálisis solo de un único riñón por primera o segunda vez, donación tras la muerte por criterios circulatorios (DMC).
    -El riñón del donante debe estar "controlado" y cumplir los criterios de Maastricht de categoría 3 o 4.
    · Categoría 3: Donante en espera de parada cardiaca
    · Categoría 4: Parada cardiaca en un donante con muerte del tronco encefálico
    3. Elegible para trasplante de riñón: Considerado elegible para trasplante después de someterse a una evaluación multidisciplinar en el centro en el que se realizará el trasplante.
    4. Inmunosupresores (en el momento del trasplante): está previsto recibir una combinación de inmunosupresores, como basiliximab, micofenolato mofetilo o azatioprina, tacrolimús y corticosteroides.
    5. Varones y mujeres:
    Varones:
    Los varones con parejas femeninas en edad fértil deben utilizar un preservativo y las parejas femeninas deben usar uno de los métodos anticonceptivos muy eficaces que se describen en el Apéndice 4 durante 180 días después de la dosis de la medicación del estudio.
    Mujeres:
    a. Ausencia de capacidad de procrear, definida como:
    - Mujeres con uno de los procedimientos siguientes documentados y sin planes para utilizar técnicas de reproducción asistida (p. ej., fecundación in vitro o transferencia de embriones de donante):
    · Ligadura de trompas bilateral o salpingectomía
    · Procedimiento documentado de oclusión histeroscópica de las trompas con confirmación de seguimiento de oclusión de trompas bilateral
    · Histerectomía
    · Ovariectomía bilateral (menopausia quirúrgica)
    - Situación posmenopáusica, definida como 12 meses de amenorrea espontánea.
    · En los casos dudosos (incluidos los casos en que se sospeche amenorrea como consecuencia de la mala función renal/diálisis de la paciente), será necesaria una muestra de sangre con concentraciones simultáneas de folitropina (FSH) y estradiol compatibles con la menopausia. Si no se dispone a tiempo de los resultados de la FSH/estradiol, las pacientes iniciarán los métodos anticonceptivos (véase a continuación y el Apéndice 4).
    · Las mujeres que estén recibiendo tratamiento hormonal sustitutivo (THS) y cuya situación menopáusica suscite dudas tendrán que utilizar uno de los métodos anticonceptivos muy eficaces si desean continuar con el THS durante el estudio.
    b. Capacidad de procrear: No deben estar embarazadas o en periodo de lactancia y deben comprometerse a utilizar una de las opciones indicadas en la Lista modificada de métodos anticonceptivos muy eficaces en mujeres con capacidad de procrear (MCP) (véase el Apéndice 4) durante 180 días después de la dosis. Si se elige un método anticonceptivo hormonal de la lista del Apéndice 4, las pacientes deben haber usado este método al menos 28 días antes de la administración de GSK1070806, o no mantener relaciones sexuales, o utilizar un preservativo como método de anticoncepción hasta que se aplique el método hormonal seleccionado durante el periodo de 28 días.
    El investigador será responsable de garantizar que los pacientes conozcan el modo correcto de empleo de estos métodos anticonceptivos proporcionando un asesoramiento directo o enviándoles a profesionales sanitarios versados en este tema.
    6. Capaz de otorgar su consentimiento informado firmado, tal como se describe en la sección 10.2, lo que incluye el cumplimiento de los requisitos y restricciones mencionados en el documento de consentimiento y en este protocolo
    E.4Principal exclusion criteria
    1. Liver function: ALT >2xULN and bilirubin >1.5xULN (view protocol for further information)
    2. QT interval: single or average QTc > 480 msec or in subjects with bundle branch block QTc > 500 msec (view protocol for further information)
    3. Concurrent medication: Subjects who receive treatment that is prohibited for safety reasons, should not receive investigational product without the explicit approval of the Medical Monitor (Sponsor)
    4. Investigational product: Any within 5 half-lives or twice the duration of the biological effect whichever is longer.
    5. Immunosuppression: Are being considered for steroid-free, anti-thymocyte globulin (ATG) or alemtuzumab induction, which have a much more profound and prolonged immunosuppressive effect than basiliximab.
    6. Prior biologic immunosuppressives: please view protocol for further information.
    7. Vaccines: A live vaccine within 30 days prior to GSK1070806 administration.
    8. Receiving a DCD kidney allograft from a donor with any of the following characteristics
    a. cold ischemic time > 36 hours
    b. age < 5 years old
    c. ABO blood type incompatible against the recipient.
    d. T- and/or B-cell positive crossmatch by complement dependent cytotoxicity or flow cytometry against the recipient.
    e. serology positive for hepatitis B (except hepatitis B surface antibody and prior vaccination), hepatitis C or human immunodeficiency virus (HIV)
    f. EBV positive donor allograft with an EBV negative recipient
    g. donor had acute or chronic bacterial, viral or fungal infection that according to the investigator causes a risk to recipient, particularly if the infection was resistant or systemic
    h. normothermic regional machine perfusion organ retrieval techniques were utilized
    i. surgical damage to donor allograft during organ procurement (view protocol for further information)
    j. ‘Uncontrolled’ Maastricht Category 1, Category 2, and Category 5 (view protocol for further information)
    9. Previous organ transplantation (view protocol for further information)
    10. Malignancy: has a history of malignancy in the past 5 years except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
    11. Acute or chronic infection: has required management of acute or chronic infections (excludes prophylaxis of infections), as follows:
    a. currently being treated for a chronic infection, which in the opinion of the investigator, could put the subject at undue risk
    b. hospitalized for treatment of infection, or treated for an infection with parenteral antibiotics within 30 days before Day 0, which in the opinion of the investigator, could put the subject at undue risk.
    c. current evidence, or history within the last 14 days, of an influenza-like illness as defined by fever (>38°C) and two or more of the following symptoms: cough, sore throat, runny nose, sneezing, limb / joint pain, headache, vomiting / diarrhoea
    d. patients with any history of active tuberculosis, view protocol for further information.
    12. Other disease/conditions. Has any of the following:
    a. clinical evidence of significant unstable or uncontrolled acute or chronic diseases, which in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
    b. a surgical procedure planned in the 12 months after Day 0, other than kidney transplantation or related procedure
    c. a known history of any other medical disease (view protocol for further information)
    13. Hepatitis B: patients will be excluded with any evidence of acute or chronic infection, or if interpretation of their results is unclear. This includes:
    a. HBsAg +
    b. Anti-HBc +
    c. HB DNA+
    It is permissible to enrol patients who are anti-HBs+ only, when this is attributable to vaccination and there is no history of previous infection.
    14. Hepatitis C: patients will be excluded if there is any evidence of past or current hepatitis C infection, including hepatitis C antibody, hepatitis C RIBA immunoblot or PCR.
    15. HIV: known to have a historically positive HIV test.
    16. Immunodeficiency: recipient with a history of, or laboratory evidence of immunodeficiency.
    17. Drug Sensitivity: has a history of sensitivity to any of the study medications including:
    a. GSK1070806
    b. background immunosuppressive regimen,
    c. designated prophylactic anti-infective therapies please see protocol for further information.
    18. Substance abuse: has clinical evidence of current drug or alcohol abuse or dependence.
    19. Co enrolment: participating in another interventional study (participation in purely observational or cohort studies is acceptable provided they do not impair feasibility, or involve excessive additional sampling).
    20. Compliance: is unlikely to comply with scheduled study visits based on investigator judgment or has a history of a psychiatric disorder or condition that may compromise communication with the investigator.
    1. Función hepática: ALT > 2 x LSN y bilirrubina > 1,5 x LSN (ver Protocolo para más información).
    2. Intervalo QT: QTc individual o promedio > 480 ms o en pacientes con bloqueo de rama QTc > 500 ms (ver Protocolo para más información).
    3. Medicamentos concomitantes: Los pacientes que reciban un tratamiento prohibido por motivos de seguridad no deben recibir el producto en investigación sin la autorización explícita del Monitor Médico (Promotor).
    4. Producto en investigación: Cualquiera en 5 semividas o dos veces la duración del efecto biológico, lo que sea más prolongado.
    5. Inmunosupresión: Considerado para inducción sin esteroides, con globulina antimocitos (GAT) o con alemtuzumab, que tienen un efecto inmunosupresor mucho más profundo y prolongado que basiliximab.
    6. Inmunosupresores biológicos previos: ver Protocolo para más información
    7. Vacunas: Una vacuna de microbios vivos en los 30 días previos a la administración de GSK1070806.
    8. Recepción de un aloinjerto renal con DMC de un donante con cualquiera de las características explicadas en el Protocolo.
    9. Trasplante de órgano previo (ver Protocolo para más información).
    10. Neoplasia maligna: el paciente tiene antecedentes de neoplasia maligna en los últimos 5 años, salvo cánceres tratados adecuadamente de la piel (basocelular o espinocelular) o carcinoma in situ del cuello uterino.
    11. Infección aguda o crónica: el paciente ha necesitado tratamiento por infecciones agudas o crónicas (excluye la profilaxis de infecciones), tal como sigue:
    a. tratamiento actual de una infección crónica que, en opinión del investigador, suponga un riesgo indebido para el paciente
    b. hospitalización para el tratamiento de una infección o tratamiento de una infección con antibióticos por vía parenteral en los 30 días previos al día 0 que, en opinión del investigador, supongan un riesgo indebido para el paciente
    c. signos actuales o antecedentes (últimos 14 días) de una enfermedad pseudogripal, definida por fiebre (> 38 °C) y dos o más de los síntomas siguientes: tos, dolor de garganta, congestión nasal, estornudos, dolor en las extremidades o articulares, cefalea, vómitos y diarrea
    d. se excluirá del estudio a los pacientes con antecedentes de tuberculosis activa, exposición reciente a la tuberculosis o, según los investigadores, riesgo de tuberculosis
    12. Otras enfermedades/circunstancias. El paciente presenta cualquiera de lo siguiente:
    a. signos clínicos de enfermedades agudas o crónicas inestables o no controladas importantes que, en opinión del investigador, puedan confundir los resultados del estudio o suponer un riesgo indebido para el paciente
    b. procedimiento quirúrgico programado en los 12 meses siguientes al día 0, distinto del trasplante renal o un procedimiento relacionado
    c. antecedente conocido de cualquier otra enfermedad (ver Protocolo para más información)
    13. Hepatitis B: se excluirá a los pacientes con cualquier signo de infección aguda o crónica, o si la interpretación de sus resultados no está clara. Ello comprende:
    a. HBsAg +
    b. Anti-HBc +
    c. ADN HB +
    Se podrá incluir pacientes que sean anti-HBs+ únicamente, cuando esto sea atribuible a la vacunación y no haya antecedentes de infección previa.
    14. Hepatitis C: se excluirá a los pacientes si hay indicios de hepatitis C antigua o actual, como anticuerpo contra la hepatitis C, inmunotransferencia RIBA de la hepatitis C o PCR.
    15. VIH: positividad histórica del VIH en el análisis.
    16. Inmunodeficiencia: receptor con antecedentes o indicios analíticos de inmunodeficiencia.
    17. Farmacosensibilidad: el paciente tiene antecedentes de sensibilidad a cualquiera de los medicamentos del estudio, como:
    a. GSK1070806
    b. pauta inmunosupresora de base,
    c. tratamientos antiinfecciosos profilácticos especificados, ver Protocolo para más información.
    18. Toxicomanía: signos clínicos de abuso o dependencia de drogas o alcohol en la actualidad.
    19.Inscripción simultánea: participación en otro estudio intervencionista (se admite la participación en estudios exclusivamente observacionales o de cohortes siempre que no alteren la viabilidad o supongan uun muestreo adicional excesivo).
    20. Cumplimiento: es improbable que el paciente acuda a las visitas del estudio programadas basándose en el criterio del investigador o el paciente tiene antecedentes de trastorno psiquiátrico o de una enfermedad que pueden dificultar la comunicación con el investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects requiring dialysis during the first 7 days post transplant, (excluding requirement for dialysis due to hyperkalemia within first 24 post-operative hours).
    Proporción de pacientes con necesidad de diálisis durante los 7 primeros días después del trasplante (excluida la necesidad de diálisis por hiperpotasemia en las primeras 24 horas del postoperatorio).
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days
    7 días
    E.5.2Secondary end point(s)
    • Serum creatinine at baseline and over time post transplant.
    • Urine output at baseline and over time post transplant.
    • Proportion of subjects in the first 7 days with:
    - Primary Non Function
    - Functional DGF
    - Intermediate Graft Function
    - Immediate Graft Function
    • Proportion of subjects with episodes of biopsy-proven acute rejection.
    • Rejection biomarkers/ PD markers (including serum IP-10 and Mig) at baseline and over time post transplant.
    • Number of dialysis events per patient in the first 30 days post transplant.
    • Proportion of subjects who are dialysis-independent at visits up to 12 months post transplant.
    • AEs and SAEs
    - Clinical laboratory values
    - Vital signs
    - Frequency, type and severity of infections
    • Serum concentrations of GSK1070806 over time, and derived pharmacokinetic parameters if feasible (AUC, Cmax).
    • Free, total, and GSK1070806 bound IL-18 at baseline and over time post transplant.
    • Frequency of anti-drug antibodies (ADAs) before and after GSK1070806 administration.
    • ADA titers.
    - Creatinina sérica en el momento basal y a lo largo del tiempo después del trasplante.
    - Diuresis en el momento basal y a lo largo del tiempo después del trasplante.
    - Proporción de pacientes en los 7 primeros días con:
    · Fallo primario del injerto
    · RFI funcional
    · Función intermedia del injerto
    · Función inmediata del injerto
    - Proporción de pacientes con episodios de rechazo agudo demostrado por biopsia.
    - Biomarcadores del rechazo/marcadores FD (como IP-10 y Mig en suero) en el momento basal y a lo largo del tiempo después del trasplante.
    - Número de episodios de diálisis por paciente en los 30 primeros días después del trasplante.
    - Proporción de pacientes independientes de la diálisis en las visitas hasta 12 meses después del trasplante.
    - AA y AAG
    · Valores de los análisis clínicos
    · Constantes vitales
    · Frecuencia, tipo e intensidad de las infecciones
    · Concentraciones séricas de GSK1070806 a lo largo del tiempo y parámetros farmacocinéticos derivados, si es posible (AUC, Cmáx).
    - IL-18 libre, total y unida a GSK1070806 en el momento basal y a lo largo del tiempo después del trasplante.
    - Frecuencia de anticuerpos antifármaco (ADA) antes y después de la administración de GSK1070806.
    - Títulos de ADA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Maximum 1 year
    máximo 1 año
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Bayesian sequential approach
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 concerned4
    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 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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Subjects will not receive any additional treatment from GSK after completion of the study because all enrolled subjects are already receiving standard of care as background therapy. The investigator is responsible for ensuring that consideration has been given to the post-study care of the subject’s medical condition. Please view section 6.8 of the protocol for further information.
    Los pacientes no recibirán ningún tratamiento adicional por parte de GSK después de finalizar el estudio porque todos los pacientes inscritos ya estarán recibiendo tratamiento habitual como tratamiento de base. El investigador será responsable de garantizar que se tenga en cuenta el tratamiento de la enfermedad del paciente después del estudio.
    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 Decision2016-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-06
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