Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2022-000887-23
    Sponsor's Protocol Code Number:CTIN816B12201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2022-07-27
    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 number2022-000887-23
    A.3Full title of the trial
    A multicenter, participant and investigator-blinded, randomized, placebo-controlled Phase 2a study to investigate the pharmacokinetics, pharmacodynamics, safety and tolerability of TIN816 in the treatment of patients with sepsis-associated acute kidney injury
    Estudio de fase IIa, multicéntrico, doble ciego (participante e investigador), aleatorizado y controlado con placebo en el que se investigan la farmacocinética, la farmacodinámica, la seguridad y la tolerabilidad de TIN816 en el tratamiento de pacientes con lesión renal aguda asociada a sepsis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter study to evaluate pharmacokinetics, safety and tolerability of TIN816 in patients with sepsis-associated acute kidney injury
    Estudio multicéntrico en el que se evalúan la farmacocinética, la seguridad y la tolerabilidad de TIN816 en pacientes con lesión renal aguda asociada a sepsis
    A.4.1Sponsor's protocol code numberCTIN816B12201
    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 SponsorNovartis Farmacéutica, 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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34 90 0353036
    B.5.5Fax number34 93 2479903
    B.5.6E-maileecc.novartis@novartis.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.3.2Product code TIN816
    D.3.4Pharmaceutical form Powder 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 INNTIN816
    D.3.9.2Current sponsor codeTIN816
    D.3.9.3Other descriptive nameTIN816
    D.3.9.4EV Substance CodeSUB218012
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute kidney injury Due to sepsis
    Lesión renal aguda asociada a sepsis.
    E.1.1.1Medical condition in easily understood language
    Acute kidney injury Due to sepsis
    Lesión renal aguda asociada a sepsis.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10069339
    E.1.2Term Acute kidney injury
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10040047
    E.1.2Term Sepsis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the pharmacokinetic profile of TIN816
    Determinar el perfil farmacocinético de TIN816
    E.2.2Secondary objectives of the trial
    To assess safety and tolerability of TIN816 vs placebo
    Evaluar la seguridad y tolerabilidad de TIN816 frente a placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent must be obtained prior to participation in the study.
    2. ≥ 18 and ≤ 85 years of age.
    3. Admitted to ICU or intermediate/high dependency care unit.
    4. Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on:
    - Suspected or confirmed infection
    - SOFA score of 2 or more (excluding renal component)
    5. Diagnosis of AKI Stage 1 or greater per the following criterion:
    - An absolute increase in serum or plasma creatinine (CR) by ≥0.3 mg/dL (≥26.5 µmol/L) within 48 hours or presumed to have occurred in the previous 48 hours as compared to the reference creatinine baseline
    - For hospital-acquired AKI, a stable serum creatinine obtained in the hospital prior to AKI should be used as reference baseline, otherwise, baseline serum creatinine in the following order of preference:
    1. Median value within 3 months of the hospital admission. If not available:
    2. Median value between 3 and 6 months prior to hospital admission. If not available:
    3. At hospital admission.
    1. La firma del consentimiento informado debe obtenerse con anterioridad a la participación del paciente en el ensayo.
    2. Edad >=18 y <=85 años.
    3. Estar ingresado en la UCI o en una unidad de cuidados intermedios/alta dependencia
    4. Diagnóstico de sepsis según los criterios definidos en The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) basándose en:
    - Sospecha de infección o infección confirmada.
    - Puntuación de 2 o superior en SOFA (excluyendo el componente renal).
    5. Diagnóstico de LRA en estadio 1 o superior según el siguiente criterio:
    - Aumento absoluto de la creatinina (CR) sérica o plasmática >=0,3 mg/dl (>=26,5 μmol/l) durante las 48 horas previas (o que supuestamente se haya producido en dicho plazo) en comparación con la creatinina basal de referencia calculada teniendo en cuenta lo siguiente:
    - En el caso de la LRA adquirida en el hospital, se deberá utilizar como valor basal de referencia la creatinina sérica estable obtenida en el hospital antes de la LRA; de lo contrario, el valor de la creatinina sérica basal será en el siguiente orden de preferencia:
    1. La mediana del valor durante los 3 meses anteriores al ingreso hospitalario. Si no se dispone de este dato:
    2. La mediana del valor entre los 3 y los 6 meses anteriores al ingreso hospitalario. Si no se dispone de este dato:
    3. El valor en el momento del ingreso hospitalario.
    E.4Principal exclusion criteria
    1. Not expected to survive for 24 hours.
    2. Not expected to survive for 30 days due to medical conditions other than SA-AKI.
    3. History of CKD with a documented estimated GFR <45 ml/min prior to development of AKI.
    4. Receiving RRT or a decision has been made to initiate RRT within 24 hours of admission.
    5. Weight is less than 40 kg or more than 125 kg .
    6. Has life support limitations (eg, do not resuscitate, do not dialyze, do not intubate).
    7. AKI diagnosis according to the AKI inclusion criteria for a period longer than 48 hours prior to study drug administration.
    8. Presence of AKI for a period longer than 48 hours prior to study drug administration as suggested by clinical manifestations, e.g., prolonged oliguria or severe renal dysfunction (eg, serum creatinine > 4 mg/dL) on admission without a history of CKD.
    9. Evidence of recovery from AKI based on the investigator’s clinical judgement prior to randomization.
    10. AKI is most likely attributable to causes other than sepsis such as nephrotoxic drugs (Non-steroidal anti-inflammatory drugs (NSAIDs), contrast, aminoglycosides), other medical conditions (e.g. heart failure, liver failure, acute abdominal aortic aneurysm, dissection, renal artery stenosis) or urinary obstruction.
    11. Documented (biopsy proven) or suspected history of acute or sub-acute kidney diseases such as rapidly progressive glomerular nephritis (RPGN) and acute interstitial nephritis (AIN).
    12. Patients who are post-nephrectomy.
    13. Patients who are on dual antiplatelet therapy.
    14. Patients who are thrombocytopenic at screening (Platelet count <100,000 microliter) or other high risk for bleeding in the opinion of the investigator.
    15. Immunosuppressed patients:
    - History of immunodeficiency diseases or known HIV test positive.
    - Is receiving immunosuppressant treatment or is on chronic high doses (high-dose therapy exceeding 2 weeks of treatment) of steroids equivalent to prednisone/prednisolone 0.5 mg/kg/day, including solid organ transplant patients. Patients with septic shock treated with hydrocortisone (e.g., 3 × 100 mg) can be included.
    16. Active hepatitis (defined as (a) abnormal liver enzymes (Alanine aminotransferase (ALT), Gamma-glutamyl transferase (GGT), ALP > 3x Upper Limit of Normal (ULN) or (b)) for active hepatitis B or C infection, a positive Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) serology or patients with advanced chronic liver disease, confirmed by a Child-Pugh score of 10–15 (Class C).
    17. Acute pancreatitis with no established source of infection.
    18. Active hematological malignancy (previous hematological malignancies that are not actively treated are allowable).
    19. Burns requiring ICU treatment.
    20. Sepsis attributed to confirmed COVID-19.
    21. Use of other investigational drugs within 5 half-lives of enrollment within 30 days (e.g., small molecules) / or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations.
    22. History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes.
    23. Any medical conditions that could significantly increase risk of participants’ safety by participating in this study according to investigator’s judgement.
    24. Women with a positive pregnancy test, pregnancy or breast feeding at Screening.
    25. Women of child-bearing potential
    1.Espereranza de vida menor a 24 h.
    2.Esperanza de vida menor a 30 días debido a otras causas diferentes del fallo renal agudo asociado a sepsis.
    3. Antecedentes de enfermedad renal crónica (ERC) con una tasa de filtración glomerular estimada (TFGe) documentada <45 ml/min antes del desarrollo de la LRA.
    4. Estar recibiendo terapia de sustitución renal (TSR) o haber decidido iniciarla durante las 24 horas anteriores al ingreso hospitalario.
    5.peso menor de 40 kg o mayor de 125 kg.
    6. Tiene limitación de soporte vital (p.ej. no resucitar, no dializar, no intubar).
    7. Presencia de fallo renal agudo durante un periodo superior a 48 horas antes de la administración del fármaco del estudio.
    8. Presencia de LRA durante un periodo superior a 48 horas antes de la administración del fármaco del estudio según parezcan indicar las manifestaciones clínicas, p. ej., oliguria prolongada o disfunción renal grave (p. ej., creatinina sérica >4 mg/dl) en el momento del ingreso hospitalario sin antecedentes de ERC.
    9. Indicios de recuperación de la LRA antes de la aleatorización según el criterio clínico del investigador.
    10.Fallo renal agudo atribuible a otras causas diferentes de la sepsis como por ejemplo medicaciones nefrotóxicas (AINES, contrastes, aminoglicosidos), otras condiciones médicas (insuficiencia cardiaca, fallo hepático, aneurismo aortico agudo abdominal, disección, estenosis de la arteria renal) u obstrucción urinaria.
    11. Antecedentes documentados (confirmados por biopsia) o sospecha de antecedentes de enfermedades renales agudas o subagudas, como glomerulonefritis rápidamente progresiva (GNRP) y nefritis intersticial aguda (NIA).
    12. Pacientes a los que se ha practicado nefrectomía.
    13. Pacientes que estén recibiendo tratamiento antiplaquetario dual.
    14. Pacientes con trombocitopenia en la selección (recuento de plaquetas <100 000 microlitros) o con riesgo elevado de sangrado por otra causa según el criterio del investigador.
    15.Pacientes inmunodeprimidos:
    - Historia de inmunodeficiencia o test de SIDA positivo confirmado.
    - Que esté recibiendo tratamiento inmunosupresor o está en dosis altas crónicas (terapia a altas dosis por más de 2 semanas) de esteroides equivalentes a prednisona/prednisolona 0,5mg/kg/dia incluidos pacientes trasplantados receptores de órganos sólidos. Pacientes con shock séptico tratados con hidrocortisona (por ejemplo 3 x 100 mg) puedes incluirse.
    16. Hepatitis activa (definida como encimas hepáticas anormales ALT, GGT, ALP >3 x límite superior de normalidad o infección por hepatitis B o C activa, positivo en serología al virus de la Hepatitis B o C o pacientes con enfermedad hepática crónica avanzada, confirmada por una puntuación Child-Pugh de 10–15 (Clase C).
    17.Pancreatitis aguda sin causa de infección establecida.
    18. Malignidad hematológica activa (se permite malignidad hematológica previa que no esté en tratamiento activo).
    19.Quemaduras que requieran tratamiento en UCI.
    20.Sepsis atribuida a Covid19.
    21. Uso de otras medicaciones en investigación 5 semividas o 30 días antes del reclutamiento para moléculas pequeñas o hasta que el efecto farmacodinamico esperado haya vuelto al estado inicial (biológicos), lo que sea más largo o más tiempo si la regulación local lo requiere.
    22. Historia de hipersensibilidad al tratamiento de estudio o a los excipientes o a medicaciones de clases terapéuticas similares.
    23.Cualquier condición médica que pueda incrementar significativamente el riesgo de seguridad del paciente por el hecho de participar en el ensayo de acuerdo con el juicio del investigador.
    24.Mujeres con test de embarazo positivo, embarazadas o en periodo de lactancia.
    25.Mujeres fértiles.
    E.5 End points
    E.5.1Primary end point(s)
    To characterize the pharmacokinetic (PK) profile of TIN816 IV infusion

    Cmax : The maximum (peak) observed serum drug concentration

    AUClast : The AUC from time zero to the last measurable concentration sampling time (tlast) (mass × time × volume-1)

    AUCinf : The AUC from time zero to infinity

    Tmax : The time to reach observed maximum drug concentration following TIN816 administration

    T1/2 : Terminal half life

    Cl : Total clearance of drug from serum after intravascular administration

    Vz : Volume of distribution from a systemic dose
    Determinar el perfil farmacocinético (PK) de perfusión IV de TIN816

    Cmax: la máxima concentración (pico) de mediación observada en suero.

    AUClast: El área bajo la curva desde tiempo cero hasta el último punto temporal de concentración medible (tlast) (masa x tiempo x volumen -1)

    AUCinf: El área bajo la curva desde tiempo cero hasta el infinito

    Tmax: el tiempo al que se observa la máxima concentración de medicación tras la administración de TIN816

    T1/2: vida media terminal

    C1: aclaramiento total de la medicación en suero tras la administración intravascular

    Vz: Volumen de distribución de dosis sistémica
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cmax : Baseline day 1, Day 2, day 3, day 5, day 8, day 14, day 30, day 60 and day 90

    AUClast : Baseline day 1, Day 2, day 3, day 5, day 8, day 14, day 30, day 60 and day 90

    AUCinf : Baseline day 1, Day 2, day 3, day 5, day 8, day 14, day 30, day 60 and day 90

    Tmax : Baseline day 1, Day 2, day 3, day 5, day 8, day 14, day 30, day 60 and day 90

    T1/2 : Baseline day 1, Day 2, day 3, day 5, day 8, day 14, day 30, day 60 and day 90

    Cl : Baseline day 1, Day 2, day 3, day 5, day 8, day 14, day 30, day 60 and day 90

    Vz : Baseline day 1, Day 2, day 3, day 5, day 8, day 14, day 30, day 60 and day 90
    Cmax : Basal día 1, Día 2, día 3, día 5, día 8, día 14, día 30, día 60 y día 90

    AUClast : Basal día 1, Día 2, día 3, día 5, día 8, día 14, día 30, día 60 y día 90

    AUCinf : Basal día 1, Día 2, día 3, día 5, día 8, día 14, día 30, día 60 y día 90

    Tmax : Basal día 1, Día 2, día 3, día 5, día 8, día 14, día 30, día 60 y día 90

    T1/2 : Basal día 1, Día 2, día 3, día 5, día 8, día 14, día 30, día 60 y día 90

    Cl : Basal día 1, Día 2, día 3, día 5, día 8, día 14, día 30, día 60 y día 90

    Vz : Basal día 1, Día 2, día 3, día 5, día 8, día 14, día 30, día 60 y día 90
    E.5.2Secondary end point(s)
    Number of participants with treatment emergent adverse events (AEs) and Serious Adverse Events (SAEs)
    Número de pacientes con eventos adversos relacionados con la medicación (AEs) y eventos adversos graves (SAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline up to 90 days
    Basal hasta 90 días
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA 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 último paciente (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days15
    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: 19
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients that are suffering of sepsis acute kidney injury are often in ICU and not abale of providing consent personally. Their legal representative will provide consent on their behalf.
    Los pacientes que sufren fallo renal agudo asociado a sepsis están a menudo ingresados en la UCI y no son capaces de dar su consentimiento. Su representante legal consentirá en su lugar.
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    No post trial treatment plans
    No hay planes de tratamiento una vez terminado el ensayo
    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 Decision2022-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-28
    P. End of Trial
    P.End of Trial StatusRestarted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 19 19:28:43 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA