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    Summary
    EudraCT Number:2018-003682-34
    Sponsor's Protocol Code Number:VKTX01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-21
    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 number2018-003682-34
    A.3Full title of the trial
    A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-Mediated Rejection in Kidney Transplant Recipients
    Ensayo esencial en fase III para evaluar la seguridad y la eficacia de Clazakizumab para el tratamiento del rechazo crónico activo mediado por anticuerpos en receptores de trasplante de riñón
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to measure how safe and successful Clazakizumab is in preventing kidney transplant rejection
    Estudio para evaluar la seguridad y la eficacia de Clazakizumab para el rechazo crónico en receptores de trasplante de riñón
    A.4.1Sponsor's protocol code numberVKTX01
    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 SponsorVitaeris Inc.
    B.1.3.4CountryCanada
    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 supportVitaeris Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVitaeris Inc.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address1500 – 355 Burrard Street
    B.5.3.2Town/ cityVancouver, BC,
    B.5.3.3Post codeV6C 2G8
    B.5.3.4CountryCanada
    B.5.5Fax number+1604-608-3822
    B.5.6E-mailregulatory@vitaerisbio.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 nameClazakizumab 12.5 mg/mL
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLAZAKIZUMAB
    D.3.9.1CAS number 1236278-28-6
    D.3.9.3Other descriptive nameCLAZAKIZUMAB
    D.3.9.4EV Substance CodeSUB117542
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Active Antibody-Mediated Rejection (CABMR) in Kidney Transplant Recipients
    Rechazo crónico activo mediado por anticuerpos en receptores de trasplante de riñón
    E.1.1.1Medical condition in easily understood language
    Kidney rejection after transplant cause by specific antibodies. This needs to be established in blood and biopsy investigations.
    Rechazo crónico activo mediado por anticuerpos en receptores de trasplante de riñón. Esto necesita ser establecido en análisis de sangre y biopsia.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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
    1. To evaluate the efficacy of clazakizumab in preventing all-cause composite allograft loss due to CABMR (defined as return to dialysis, allograft nephrectomy, re-transplantation, estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m^2 or death from any cause) (Final Analysis).
    2. To evaluate the efficacy of clazakizumab in slowing/preventing the progressive loss of kidney function (as measured by eGFR using the Modification of Diet in Renal Disease 4 (MDRD4) equation) (Interim Analysis #2 (IA #2)).
    3. To evaluate the safety of clazakizumab.
    1. Evaluar la eficacia de clazakizumab en la prevención de la pérdida del aloinjerto por todas las causas combinadas debido a RCAMA (definida como el regreso a diálisis, nefrectomía del aloinjerto, retrasplante, tasa de filtración glomerular estimada [TFGe] <15 ml/min/1,73 m2 o muerte por cualquier causa) (Análisis final).
    2. Evaluar la eficacia de clazakizumab para retrasar/prevenir la pérdida progresiva de la función renal (medida mediante la TFGe empleando la ecuación de la Modificación de la dieta en la enfermedad renal [MDRD4]) (análisis intermedio número 2 [AI N.º 2]).
    3. Evaluar la seguridad de clazakizumab.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effects of clazakizumab on death-censored allograft loss (defined as return to dialysis, allograft nephrectomy, re-transplantation or eGFR <15 mL/min/1.73 m^2 but excluding death from any cause).
    2. To evaluate the effects of clazakizumab on albuminuria.
    3. To evaluate the effects of clazakizumab on DSA titers and mean fluorescence intensity (MFI) scores.
    4. To evaluate the effects of clazakizumab on incidence of acute rejection episodes (TCMR and ABMR).
    5. To evaluate the effects of clazakizumab on the histology of kidney biopsies according to the Banff 2015 lesion grading scores.
    6. To evaluate the effects of clazakizumab on overall patient survival.
    7. To evaluate the effects of clazakizumab on healthcare utilization due to ABMR and patient reported outcomes including health-related quality of life (HRQoL).
    1. Evaluar los efectos de clazakizumab en la pérdida del aloinjerto con muerte censurada (definida como el regreso a diálisis, nefrectomía del aloinjerto, retrasplante o TFGe <15 ml/min/1,73 m2, pero excluyendo la muerte por cualquier causa).
    2. Evaluar los efectos de clazakizumab sobre la albuminuria.
    3. Evaluar los efectos de clazakizumab sobre los títulos de AED y las puntuaciones de intensidad media de fluorescencia (IMF).
    4. Evaluar los efectos de clazakizumab sobre la incidencia de episodios de rechazo agudo (RMCT y RAMA).
    5. Evaluar los efectos de clazakizumab sobre la histología de las biopsias renales según las puntuaciones conforme a la clasificación de lesiones de Banff de 2015.
    6. Evaluar los efectos de clazakizumab sobre la supervivencia global del paciente.
    7. Evaluar los efectos de clazakizumab sobre la utilización de recursos sanitarios debido al RAMA, y los resultados notificados por el paciente, incluida la calidad de vida relacionada con la salud (CdVRS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18-70 years.
    2. Living donor/deceased donor kidney transplant recipients ≥6 months from time of transplant.
    3. Diagnosis of CABMR (according to Banff 2015 diagnostic criteria) to include all of the following:
    • Biopsy-proven CABMR (i.e., chronic glomerulopathy (cg) >0) with/without C4d staining. Repeat biopsy to be performed if previous biopsy is not within 6 months of the start of the screening period. The local pathologist’s diagnosis will be reviewed by a central pathologist to confirm eligibility for entry into the study. Subjects without evidence of chronic tissue injury on light microscopy but who have glomerular basement membrane double contours on electron microscopy (cg1a) are eligible.
    • Positive for human leukocyte antigen (HLA) DSA (using single-antigen bead-based assays) post-transplant. Local laboratory DSA results will be reviewed by the central HLA reviewer to confirm eligibility for entry into the study. A single antigen bead MFI >1,000 will be considered positive. If presence of HLA DSA is confirmed within 6 months of the start of the screening period, the test does not need to be repeated for eligibility. • Note: Treatments for ABMR (including CABMR) or TCMR are not allowed within 3 months of the start of screening (see Exclusion Criterion 3). If a subject has received one of these treatments at any
    time prior, a repeat biopsy and repeat DSA must be performed after halting / completing treatment (to show continuing CABMR).
    4. Written informed consent obtained from subject (or legally Written informed consent obtained from subject (or legally acceptable representative) before any trial-related procedures.
    1. Edad 18-70 años.
    2. Receptores de un trasplante de riñón de un donante vivo/donante fallecido ≥6 meses desde el momento del trasplante.
    3. Diagnóstico de RCAMA (según los criterios diagnósticos de Banff 2015) que debe incluir todo lo siguiente:
    • RCAMA confirmado por biopsia (es decir, glomerulopatía crónica [gc] > 0) con o sin tinción con C4d. Si la biopsia anterior no tuvo lugar en el periodo de 6 meses anteriores del inicio del periodo de selección, se repetirá la biopsia. El diagnóstico del patólogo local será revisado por un patólogo revisor central para confirmar la aptitud para entrar en el estudio. Los sujetos sin indicios de lesión tisular crónica en la microscopía óptica, pero que tienen dobles contornos en la membrana basal glomerular en la microscopia electrónica (cg1a) son aptos.
    • Positivo de AED contra el antígeno leucocitario humano (ALH) (utilizando ensayo con esferas de antígeno único) después del trasplante. Los resultados relativos a los AED del laboratorio local serán revisados por el laboratorio revisor de ALH para confirmar la aptitud para entrar en el estudio. Un simple antigeno MFI>1000 se considerará positivo. Si se confirma la presencia de AED contra el ALH en los 6 meses anteriores del inicio de la selección, no será necesario repetir la prueba para confirmar la aptitud.
    • Nota: Si el sujeto ha recibido tratamiento para el RAMA (incluido el RCAMA) o RMCT no se permiten los tres meses anteriores del periodo de preselección de 3 meses (Ver punto 3 del criterio de exclusión). Si el paciente ha recibido uno de estos tratamientos con anterioridad, la biopsia y la prueba de detección de AED debe ser realizada despues de parar/completar el tratamiento (que debe mostrar que el RCAMA continúa).
    4. Consentimiento informado por escrito obtenido del sujeto (o de su representante legal) antes de realizar cualquier procedimiento relacionado con el ensayo.
    E.4Principal exclusion criteria
    1. Participant is unable or unwilling to comply with study procedures in the opinion of the Investigator.
    2. Multi-organ transplant recipient or cell transplant (islet, bone marrow, stem cell) recipient.
    3. Treatment for ABMR (including CABMR) or TCMR within 3 months of the start of screening.
    4. Received T cell depleting agents (e.g., alemtuzumab, anti-thymocyte globulin) within 3 months of the start of the screening.
    5. Treatment with mTOR inhibitors within 4 weeks of the start of the screening.
    6. Biopsy showing pure TCMR or advanced interstitial fibrosis (ci3), advanced tubular atrophy (ct3), vascular fibrous intimal thickening (cv3) or other significant causes of renal dysfunction (e.g., polyoma BK virus (BKV) nephropathy, glomerulonephritis).
    7. Impaired renal function due to disorders in the transplanted allograft (e.g., renal artery stenosis, hydronephrosis).
    8. eGFR <25 mL/min/1.73 m^2 or >65 mL/min/1.73 m^2
    9. Nephrotic range proteinuria defined as spot urine protein creatinine ratio (UPCR) ≥3,000 mg/g (≥300 mg/mmol) or spot urine albumin creatinine ratio (UACR) ≥2,200 mg/g (≥220 mg/mmol). If spot UPCR or UACR is above defined limits, repeat test on separate day to confirm ineligibility (or collect 24-hour urine to confirm nephrotic range proteinuria (≥3.0 g/day)).
    10. Pregnant, breastfeeding, or unwillingness to practice highly effective birth control during the study and for 5 months after last dose of investigational drug.
    11. History of anaphylaxis.
    12. Abnormal liver function tests (LFTs) (alanine aminotransferase (ALT)/aspartate aminotransferase (AST)/bilirubin >1.5 x upper limit of normal) or other significant liver disease.
    13. History of active tuberculosis (TB).
    14. History of latent TB (e.g., positive QuantiFERON-TB test) without history of active TB unless subject has completed a full course of prophylactic treatment.
    15. History of human immunodeficiency virus (HIV) infection or positive for HIV.
    16. Seropositive for hepatitis B surface antigen (HBsAg).
    17. Hepatitis C virus (HCV) RNA positive.
    18. Known Epstein-Barr virus (EBV) mismatch: donor seropositive, recipient seronegative.
    19. History of gastrointestinal perforation, diverticular disease or diverticulitis, or inflammatory bowel disease.
    20. Neutropenia (<1,000/mm^3) or thrombocytopenia (<50,000/mm^3).
    21. Active infections requiring systemic antimicrobial agents and unresolved prior to screening.
    22. History of or current invasive fungal infection or other opportunistic infection, including (but not limited to) the following: a nontuberculous mycobacterial infection, aspergillosis, pneumocystosis, and toxoplasmosis.
    23. Active viral infections such as BKV, CMV, or EBV based on polymerase chain reaction (PCR) testing.
    24. Current or recent (within 3 months) participation in an interventional trial.
    25. Administration of a live vaccine within 6 weeks of the start of screening, including but not limited to the following:
    • Adenovirus
    • Measles, mumps, and rubella
    • Oral polio
    • Oral typhoid
    • Rotavirus
    • Varicella zoster
    • Yellow fever
    26. History of alcohol or illicit substance (including marijuana) abuse.
    27. Present or previous (within 3 years) malignancy except for basal cell carcinoma, fully excised squamous cell carcinoma of the skin, or non-recurrent (within 5 years) cervical carcinoma in-situ.
    28. Presence of a condition or abnormality (i.e., clinically significant endocrine, autoimmune, metabolic, neurological, psychiatric/psychological, renal, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment) that in the opinion of the Investigator would compromise the safety or life expectancy of the patient or the quality of the data.
    29. History of intolerance to trimethoprim and/or sulfamethoxazole. This criterion does not apply if subject is already taking an other suitable Investigator-approved alternative for PJP prophylaxis, or if subject is willing to begin taking an Investigator-approved alternative prophylactic therapy at least 1 week prior to the Day 1 Baseline visit (Visit 2).
    30. Prior exposure to clazakizumab.
    31. ABO-incompatible transplant recipient.
    32. Severe hypogammaglobulinemia (defined as immunoglobulin G (IgG) <400 mg/dL).
    33. Prior exposure to proteasome inhibitors (e.g., bortezomib).
    1. El participante no es capaz o no está dispuesto a cumplir con los procedimientos del estudio en opinión del investigador.
    2. Receptor de un trasplante multiorgánico o de trasplante de células (islotes, médula ósea, células madre).
    3. Tratamiento para el RAMA (incluido el RCAMA) o RMCT en los 3 meses anteriores al inicio de la selección.
    4. Haber recibido fármacos reductores de los linfocitos T (p. ej., alemtuzumab, globulina antitimocítica) en los 3 meses anteriores al inicio de la selección.
    5. Tratamiento con inhibidores de mTOR en las 4 semanas anteriores al inicio de la selección.
    6. Biopsia que muestra RMCT puro o fibrosis intersticial en estadio avanzado (ci3), atrofia tubular en estadio avanzado (ct3), engrosamiento fibrovascular de la íntima (cv3) u otras causas importantes de disfunción renal (p. ej., nefropatía por poliomavirus BK [VBK], glomerulonefritis).
    7. Deterioro de la función renal debido a trastornos en el aloinjerto trasplantado (p. ej., estenosis de la arteria renal, hidronefrosis).
    8. TFGe <25 ml/min/1,73 m2 o >65 ml/min/1,73 m2
    9. Proteinuria en rango nefrótico, que se define como cociente de proteína/creatinina en la prueba rápida de orina (CPCO) ≥3000 mg/g (≥300 mg/mmol) o cociente de albúmina/creatinina en la prueba rápida de orina (CACO) ≥2200 mg/g (≥220 mg/mmol). Si el CPCO o CACO en la prueba rápida de orina está por encima de los límites definidos, se repetirá la prueba un día distinto para confirmar que el sujeto no es apto (o se recogerá la orina de 24 horas para confirmar la proteinuria en rango nefrótico [≥3,0 g/día]).
    10. Mujeres embarazadas, en periodo de lactancia o que no estén dispuestas a practicar un método anticonceptivo altamente eficaz durante el estudio y durante 5 meses después de la última dosis del fármaco en investigación.
    11. Antecedentes de anafilaxis.
    12. Resultados anómalos en las pruebas de la función hepática (PFH) (alanina aminotransferasa [ALT]/aspartato aminotransferasa [AST]/bilirrubina >1,5 x límite superior de la normalidad) u otra enfermedad hepática importante.
    13. Antecedentes de tuberculosis activa (TB).
    14. Antecedentes de TB latente (p. ej., resultado positivo de la prueba de QuantiFERON-TB) sin antecedentes de TB activa a menos que el sujeto haya completado un ciclo completo de tratamiento profiláctico.
    15. Antecedentes de infección por el virus de la inmunodeficiencia humana (VIH) o positivo para el VIH.
    16. Seropositivo para el antígeno de superficie de la hepatitis B (AgsHB).
    17. Positivo para el ARN del virus de la hepatitis C (VHC).
    18. Incompatibilidad conocida para el virus de Epstein-Barr (VEB): donante seropositivo, receptor seronegativo.
    19. Antecedentes de perforación gastrointestinal, enfermedad diverticular o diverticulitis, o enfermedad inflamatoria intestinal.
    20. Neutropenia (<1000/mm3) o trombocitopenia (<50 000/mm3).
    21. Infecciones activas que requieren antibióticos sistémicos y no se han resuelto antes de la selección.
    22. Antecedentes de, o infección fúngica invasiva actual u otras infecciones oportunistas, incluidas (entre otras) las siguientes: una infección por micobacterias no tuberculosas, aspergilosis, neumocistosis, y toxoplasmosis.
    23. Infecciones víricas activas, como VBK, CMV o VEB conforme a la prueba de reacción en cadena de la polimerasa (RCP).
    24. Participación actual o reciente (en los 3 últimos meses) en un ensayo intervencionista.
    25. Administración de una vacuna viva en las 6 semanas anteriores al inicio de la selección, incluidas, entre otras, las siguientes:
    • Adenovirus
    • Sarampión, paperas y rubeola
    • Vacuna oral contra la poliomielitis
    • Vacuna oral contra la fiebre tifoidea
    • Rotavirus
    • Varicela zóster
    • Fiebre amarilla
    26. Antecedentes de abuso de alcohol o sustancias ilegales (incluida la marihuana).
    27. Neoplasia maligna actual o anterior (en los últimos 3 años), con la excepción de carcinoma basocelular, carcinoma de células escamosas de la piel completamente extirpado o carcinoma cervical in situ no recurrente (en los últimos 5 años).
    28. Presencia de una afección o anomalía (es decir, anomalías endocrinas, autoinmunes, metabólicas, neurológicas, psiquiátricas/psicológicas, renales, gastrointestinales, hepáticas y hematológica, o de cualquier otro sistema que no estén controladas con el tratamiento de referencia) que, en opinión del investigador, comprometería la seguridad o esperanza de vida del sujeto o la calidad de los datos.
    29. Historia de intolerancia a la trimetoprima y / o sulfametoxazol. Este criterio no se aplica si el sujeto ya está tomando otra
    alternativa aprobada por el investigador para la profilaxis con PJP, o si el sujeto está dispuesto a comenzar a tomar una terapia profilactica alternativa aprobada por el investigador al menos 1 semana antes de la visita basal del día 1 (visita 2)
    30. Exposición previa a clazakizumab
    31 Receptor de transplante incompatible ABO.
    E.5 End points
    E.5.1Primary end point(s)
    Final Analysis Primary Endpoint:
    Time to all-cause composite allograft loss (defined as return to dialysis, allograft nephrectomy, re-transplantation, eGFR <15 mL/min/1.73 m^2 or death from any cause (including death with functioning allograft)). An eGFR <15 mL/min/1.73 m^2 must be confirmed by a repeat measurement taken between 14 to 30 days later. Temporary return to dialysis due to acute kidney injury (AKI) and temporary eGFR decline to <15 mL/min/1.73 m^2 due to AKI are both excluded.
    Tiempo hasta la pérdida del aloinjerto por todas las causas combinadas (definida como el regreso a diálisis, nefrectomía del aloinjerto, retrasplante, TFGe, < 15 ml/min/1,73 m2 o muerte por cualquier causa [incluida la muerte con aloinjerto funcional]). Se debe confirmar una TFGe < 15 ml/min/1,73 m2 mediante una repetición de la medición entre 14 y 30 días después. Queda excluido el regreso temporal a diálisis debido a una lesión renal aguda (LRA), así como un descenso temporal de la TFGe < 15 ml/min/1,73 m2 debido a una LRA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint will be analyzed as part of the final analysis when approximately 221 all-cause allograft loss events have occurred.
    El criterio de valoración principal de la eficacia se analizará como parte del análisis final cuando se hayan producido aproximadamente 221 acontecimientos de pérdida del aloinjerto por cualquier causa.
    E.5.2Secondary end point(s)
    • Incidence and time to death-censored allograft loss.
    • Change in mean eGFR from Baseline to End of Study (EOS).
    • Change in spot UACR from Baseline to EOS.
    • Change in DSA titers and MFI scores from Baseline to EOS.
    • Incidence of acute rejection episodes (TCMR and ABMR) from Baseline to EOS.
    • Change in Banff lesion grading score (2015 criteria) of pre-treatment to post treatment (Week 52) kidney biopsies.
    • Overall patient survival.
    • Healthcare utilization associated with the treatment of ABMR to Week 52 as well as to EOS.
    • Change in patient reported outcomes (including HRQoL) from Baseline to Week 52 as well as to EOS, using multiple tools.
    • Incidencia y tiempo hasta la pérdida del aloinjerto con muerte censurada.
    • Cambio en la TFGe media desde el inicio hasta el fin del estudio (FdE).
    • Cambio en el CACO en la prueba rápida de orina desde el inicio hasta el FdE.
    • Cambio en los títulos de AED y en las puntuaciones de la IMF desde el inicio hasta el FdE.
    • Incidencia de episodios de rechazo agudo (RMCT y RAMA) desde el inicio hasta el FdE.
    • Cambio en la puntuación conforme a la clasificación de lesiones de Banff (criterios de 2015) en las biopsias renales de antes del tratamiento y después del tratamiento (semana 52).
    • Supervivencia global del paciente.
    • Utilización de recursos sanitarios debido al tratamiento del RAMA hasta la semana 52, así como hasta el FdE.
    • Cambio en los resultados notificados por el paciente (incluida la CdVRS) desde el inicio hasta la semana 52, así como hasta el FdE, utilizando varias herramientas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Baseline to Week 52 and / or End of Study (EOS) as detailed above
    De la visita inicial a la semana 52 y/o del fin del estudio como se ha detallado arriba
    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 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 Yes
    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) 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 No
    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 EEA7
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Israel
    United States
    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
    LVLS
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months10
    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: 310
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 350
    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)
    The post-trial treatment will be performed by the trial investigator and/or the patient’s non-trial physician based on guidance from the trial investigator as applicable. This could also involve further treatment with Interleukin-6 inhibitors, if required.
    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 Decision2019-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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