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    Summary
    EudraCT Number:2017-004902-16
    Sponsor's Protocol Code Number:Nef-301
    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:2018-03-02
    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 number2017-004902-16
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd).
    Estudio randomizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de Nefecon en pacientes con nefropatía por IgA primaria en riesgo de progresión a enfermedad renal terminal (NefIgArd)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.
    Estudio en el que se compara la seguridad y eficacia de Nefecon con placebo en pacientes con nefropatía por IgA primaria
    A.4.1Sponsor's protocol code numberNef-301
    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 SponsorCalliditas Therapeutics AB
    B.1.3.4CountrySweden
    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 supportCalliditas Therapeutics AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCalliditas Therapeutics AB
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressWallingatan 26B
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code111 24
    B.5.3.4CountrySweden
    B.5.4Telephone number4676394 98 72
    B.5.6E-mailfredrik.juhlin@calliditas.se
    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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/139/16 (EMA/COMP/513517/2016)
    D.3 Description of the IMP
    D.3.1Product nameNefecon
    D.3.2Product code Nefecon
    D.3.4Pharmaceutical form Modified-release capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.3Other descriptive nameNefecon
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboModified-release capsule, hard
    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
    Primary IgA nephropathy patients at risk of developing end stage renal disease
    Pacientes con Nefropatía por IgA primaria en riesgo de progresión a enfermadad renal terminal
    E.1.1.1Medical condition in easily understood language
    Patients with kidney diseases that have damage to the kidneys associated with Immunoglobulin A
    Pacientes con enfermedades renales con daño renal asociado con inmunoglobulina A
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10069341
    E.1.2Term Berger's disease
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A:
    The primary objective of Part A is to assess the effect of Nefecon 16 mg treatment on urine protein to creatinine ratio (UPCR) over 9 months compared to placebo.
    Part B:
    The primary objective of Part B is to assess the effect of the Nefecon treatment given in Part A on long-term clinical consequences of any proteinuria reduction as measured by the time to 30% reduction in estimated glomerular filtration rate (eGFR) compared to placebo.
    Parte A
    El objetivo principal de la Parte A es evaluar el efecto del tratamiento con Nefecon 16 mg sobre el cociente proteína/creatinina en orina (CPCO) a lo largo de 9 meses, en comparación con placebo.
    Parte B
    El objetivo principal de la Parte B es evaluar el efecto del tratamiento con Nefecon administrado en la Parte A sobre las consecuencias clínicas a largo plazo de cualquier reducción de la proteinuria medida mediante el tiempo transcurrido hasta una reducción del 30 % en la filtración glomerular estimada (FGe), en comparación con placebo.
    E.2.2Secondary objectives of the trial
    Part A:
    The secondary objectives of Part A are to evaluate additional aspects of renal function, and safety and tolerability of Nefecon 16 mg treatment over 9 months compared to placebo.
    Part B:
    The secondary objectives of Part B are to assess the long-term effects of the Nefecon treatment given in Part A on different aspects of renal function and long-term safety compared to placebo.
    Parte A
    Los objetivos secundarios de la Parte A son evaluar aspectos adicionales de la función renal, y la seguridad y tolerabilidad del tratamiento con Nefecon 16 mg a lo largo de 9 meses, en comparación con placebo.
    Parte B
    Los objetivos secundarios de la Parte B son evaluar los efectos a largo plazo del tratamiento con Nefecon administrado en la Parte A sobre diferentes aspectos de la función renal y la seguridad a largo plazo en comparación con placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria at screening to be eligible for admission into the study:
    1. Female or male patients 18 years of age;
    2. Diagnosed IgAN with biopsy verification within the past 5 years;
    3. On a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or MTD according to the 2012 KDIGO guidelines for the 3 months prior to screening. In this instance, a stable dose is defined as doses within 25% of the dose at screening. Patients that are on a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) that is below the maximum allowed dose or MTD according to the 2012 KDIGO guidelines will be permitted into the study if an attempt to reach the maximum allowed dose or MTD was previously performed; and
    4. Willing and able to provide written informed consent at screening.
    In addition, patients must meet the following inclusion criteria before randomization into the study:
    5. Proteinuria based on 2 consecutive measurements (based on 24-hour urine sampling) after informed consent, separated by at least 2 weeks and calculated by the central laboratory. Both samples must show either of the following:
    - Proteinuria 1 g per day, or
    - UPCR 0.8 g/gram; and
    6. eGFR 45 mL/min per 1.73 m2 and 90 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, confirmed by the central laboratory.
    Los pacientes deben cumplir todos los criterios de inclusión siguientes en el screening para ser elegibles para participar en el estudio:
    1.Pacientes de ambos sexos mayores de 18 años;
    2.Con diagnóstico de NIgA verificada mediante biopsia en los últimos 5 años;
    3.En tratamiento con una dosis estable de un inhibidor de RAS (IECA y/o ARA-II), a la dosis máxima permitida o DMT según las directrices de KDIGO de 2012 durante los 3 meses previos al screening. En este caso, una dosis estable se define como dosis comprendidas en un 25 % de la dosis en el screening. Los pacientes que estén en tratamiento con una dosis estable de un inhibidor de RAS (IECA y/o ARA-II) que sea inferior a la dosis máxima permitida o DMT según las directrices de KDIGO de 2012 podrán participar en el estudio si con anterioridad se intentó alcanzar la dosis máxima permitida o la DMT;21 y
    4.Pacientes dispuestos a proporcionar el consentimiento informado por escrito en el screening y capaces de hacerlo.
    Además, los pacientes deben cumplir los siguientes criterios de inclusión antes de la randomización en el estudio:
    5.Proteinuria basada en 2 determinaciones consecutivas (realizadas en una muestra de orina de 24 horas) efectuadas una vez obtenido el consentimiento informado, separadas por un mínimo de 2 semanas y calculadas por el laboratorio central. Las dos muestras deben mostrar alguno de los siguientes valores:
    - Proteinuria mayor de 1 g al día, o
    - CPCO mayor o igual a 0,8 g/gramo; y
    6.FGe mayor de 45 ml/min por 1,73 m2 y menor de 90 ml/min por 1,73 m2 usando la fórmula de Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), confirmada por el laboratorio central.
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria at screening will not be eligible for admission into the study:
    1. Systemic diseases that may cause mesangial IgA deposition including, but not limited to, Henoch Schönlein purpura, systemic lupus erythematosus, dermatitis herpetiformis, and ankylosing spondylitis;
    2. Patients who have undergone a kidney transplant;
    3. Patients with acute or chronic infectious disease including hepatitis, tuberculosis, human immunodeficiency virus (HIV), and chronic urinary tract infections;
    4. Patients with liver cirrhosis, as assessed by the Investigator;
    5. Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled (defined as hemoglobin A1c [HbA1c] 8% [64 mmol/mol]);
    6. Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator;
    7. Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator; patients with 140 mmHg systolic blood pressure or 90 mmHg diastolic blood pressure are not eligible;
    8. Patients with diagnosed malignancy within the past 5 years, except for treated basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, colon polyps, or cervical carcinoma in situ;
    9. Patients with known osteoporosis in medium- or high-risk category according to the 2010 American College of Rheumatology recommendations;
    10. Patients with known glaucoma, known cataract(s), and/or history of cataract surgery, unless the surgery was performed on both eyes;
    11. Gastrointestinal disorders (eg, peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea) that may interfere with the effects of the study drug;
    12. Patients with hypersensitivity to budesonide or any component of the study drug formulation;
    13. Patients with previous severe adverse reactions to steroids, at the discretion of the Investigator, including psychotic symptoms;
    14. Patients who have been treated with immunosuppressive medications, other than GCSs, within the past 2 years. See Appendix F for more information on immunosuppressive medications;
    15. Patients who have been treated with any systemic GCSs within the past 3 months;
    16. Patients who have been treated with any systemic GCSs within the past 2 years except for a maximum of 3 periods of 2 weeks with the equivalent of 0.5 mg/kg prednisolone or less, for non-IgAN indications;
    17. Patients taking potent inhibitors of cytochrome P450 (CYP) 3A4;
    18. Current or prior (within the past 2 years) alcohol or drug abuse;
    19. Intake of an investigational drug within 30 days and at least 5 half-lives;
    20. Patients unwilling or unable to meet the requirements of the protocol;
    21. Other medical or social reasons for exclusion at the discretion of the Investigator;
    22. Life expectancy 5 years;
    23. Females who are pregnant, breastfeeding, or unwilling to use highly-effective contraception during the Treatment Period and the 3-month Follow-up Period in Part A of the study (contraception only required for women of childbearing potential [WOCBP]);
    - Highly-effective methods of contraception are defined as those that achieve a low failure rate (1% per year) when used consistently and correctly. Such methods include the use of combined (estrogen and progesterone) hormonal contraceptives (oral, intravaginal, or transdermal), progesterone-only hormonal contraceptives (oral, injectable, or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence;
    - WOCBP are defined as women who are not surgically or chemically sterilized, including hysterectomy or bilateral oophorectomy (tubal ligation is not acceptable), and who are between menarche and 1 year post-menopause; and
    - Postmenopausal is defined as amenorrhoeic for at least 1 year AND, if aged under 60 years have a serum follicle-stimulating hormone (FSH) level of at least 30 IU/L. Women who are taking hormone replacement therapy (HRT) do not have to have FSH assessments, but the amenorrhea (before starting HRT) must have been naturally (spontaneously) occurring and have been accompanied by an appropriate clinical profile (eg, age appropriate, history of vasomotor symptoms); or
    24. Staff involved in the conduct of the study.
    1.Enfermedades sistémicas que puedan causar depósito de IgA mesangial, incluyendo púrpura de Henoch Schönlein, lupus eritematoso sistémico, dermatitis herpetiforme y espondilitis anquilosante
    2.Pacientes a los que se haya realizado un trasplante renal
    3.Pacientes con una enfermedad infecciosa aguda o crónica, tales como hepatitis, tuberculosis, infección por el virus de la inmunodeficiencia humana (VIH) e infecciones urinarias crónicas
    4.Pacientes con cirrosis hepática, según la evaluación del investigador
    5.Pacientes con diagnóstico de diabetes mellitus de tipo 1 o tipo 2 que esté mal controlada (definida como un valor de hemoglobina A1c [HbA1c] mayor de 8 % [64 mmol/mol
    6.Pacientes con antecedentes de angina inestable, insuficiencia cardíaca congestiva de clase III o IV y/o arritmia clínicamente significativa, según valoración del investigador
    7.Pacientes con control inaceptable de la presión arterial, definido como una presión arterial consistentemente por encima de los valores de las directrices nacionales para enfermedad renal proteinúrica, según la evaluación del investigador; los pacientes con una presión arterial sistólica mayor de140 mm Hg o una presión arterial diastólica mayor de 90 mm Hg no son elegibles
    8.Pacientes con una neoplasia maligna diagnosticada en los últimos 5 años, salvo carcinoma basocelular cutáneo tratado, carcinoma cutáneo epidermoide resecado con intención curativa, pólipos de colon o carcinoma de cuello uterino in situ
    9.Pacientes con osteoporosis conocida en la categoría de riesgo intermedio o alto según las recomendaciones de 2010 del American College of Rheumatology
    10.Pacientes con glaucoma o cataratas diagnosticados o con antecedentes de cirugía de cataratas, salvo que la cirugía se haya realizado en ambos ojos
    11.Trastornos gastrointestinales (p. ej., enfermedad ulcerosa péptica, enfermedad inflamatoria intestinal y diarrea crónica) que puedan interferir en los efectos del fármaco del estudio
    12.Pacientes con hipersensibilidad conocida a la budesonida o a cualquier componente de la formulación del fármaco del estudio
    13.Pacientes con reacciones adversas severas previas a esteroides, según el criterio del investigador, incluidos síntomas psicóticos
    14.Pacientes que han recibido tratamiento con medicamentos inmunosupresores, distintos de GCS, en los dos últimos años. Véase en el Anexo F más información sobre los medicamentos inmunosupresores
    15.Pacientes que han recibido tratamiento con medicamentos GCS sistémicos en los tres últimos meses
    16.Pacientes que han recibido tratamiento con GCS sistémicos en los dos últimos años, salvo durante un máximo de 3 periodos de 2 semanas con el equivalente de 0,5 mg/kg de prednisolona o menos, para indicaciones distintas de NIgA
    17.Pacientes en tratamiento con inhibidores potentes del citocromo P450 (CYP) 3A4
    18.Alcoholismo o drogadicción en la actualidad o en el pasado (en los últimos dos años)
    19.Administración de un fármaco en investigación en los 30 días anteriores y como mínimo 5 semividas
    20.Pacientes que no están dispuestos a cumplir los requisitos del protocolo o no son capaces de hacerlo
    21.Otros motivos médicos o sociales para la exclusión, según el criterio del investigador
    22.Esperanza de vida menor de 5 años
    23.Mujeres que están embarazadas, en periodo de lactancia o no están dispuestas a utilizar un método anticonceptivo de gran eficacia durante el periodo de tratamiento y el periodo de seguimiento de 3 meses de la Parte A del estudio (la anticoncepción solo es obligatoria en las mujeres con capacidad de procrear);
    - Los métodos anticonceptivos de gran eficacia se definen como aquellos que tienen una tasa de fallo baja (menos de 1 % anual) cuando se usan de forma correcta y sistemática. Dichos métodos incluyen el uso de anticonceptivos hormonales (orales, intravaginales o transdérmicos) combinados (estrógeno y progesterona), anticonceptivos de solo progesterona (orales, inyectables o implantables), dispositivo intrauterino, sistema de liberación hormonal, oclusión tubárica bilateral, vasectomía de la pareja o abstinencia sexual;
    - Las mujeres con capacidad de procrear son mujeres no esterilizadas por métodos quirúrgicos ni químicos, incluyendo histerectomia, ooforectomía bilateral (la ligadura de trompas no es aceptable) y que están entre la menarquía y el primer año de menopausia; y
    - Las mujeres posmenopáusica son mujeres amenorreicas durante un mínimo de 1 año Y, si tienen menos de 60 años, con unos niveles séricos de hormona foliculoestimulante (FSH) de al menos 30 UI/l. En las mujeres que estén recibiendo Terapia Hormonal Sustitutiva (TSH) no es necesario valorar los niveles de FSH, pero la amenorrea (antes del inicio del TSH) debe haberse producido de forma natural (espontánea) e ir acompañada por un perfil clínico adecuado (p. ej., edad apropiada, antecedentes de síntomas vasomotores)
    24.Personal involucrado en la realización del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for the final analysis is defined as the time from the first dose of study drug until the first occurrence of a 30% reduction from baseline in eGFR (CKD-EPI). The 30% reduction must be confirmed by a second value obtained within 30 days to 100 days of the original.
    El criterio principal de valoración de la eficacia para el análisis final se define como el tiempo transcurrido desde la primera dosis del fármaco del estudio hasta la aparición por primera vez de una reducción del 30 % respecto al periodo basal en la FGe (CKD-EPI). La reducción del 30 % debe confirmarse mediante un segundo valor obtenido en un plazo de 30 días a 100 días del valor original.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A formal interim analysis of the full study will be performed when 50 clinical events, defined as occurrence of a 30% reduction from baseline in eGFR, have occurred.
    Cuando se hayan producido 50 acontecimientos clínicos, definidos como la presencia de una reducción del 30 % respecto al periodo basal en la FGe, se llevará a cabo un análisis intermedio formal de todo el estudio.
    E.5.2Secondary end point(s)
    • Time from the first dose of study drug until the first occurrence of the initiation of maintenance dialysis for at least 1 month, kidney transplantation, or kidney failure defined as a sustained eGFR <15 mL/min/1.73 m2, or death due to kidney failure;
    • Ratio of UPCR, UACR, and eGFR (CKD-EPI) compared to baseline averaged over time points between 12 and 24 months inclusive following the first dose of study drug;
    • Time to 40% reduction from baseline in eGFR (CKD-EPI) confirmed by a second value obtained within 30 days to 100 days;
    • Time to 50% reduction from baseline in eGFR (CKD-EPI) confirmed by a second value obtained within 30 days to 100 days;
    • Proportion of patients with a total proteinuria level 1 g per 24 hours or UPCR 0.8 g/gram at 12, 18, and 24 months following the first dose of study drug, and at the last study visit;
    • Proportion of patients with proteinuria 1 g per 24 hours or UPCR 0.8 g/gram in at least 2 of the following time points: 12, 18, and 24 months following the first dose of study drug;
    • Proportion of patients without microhematuria at 12, 18, and 24 months following the first dose of study drug, and at the last study visit;
    • Proportion of patients without microhematuria in at least 2 of the following time points: 12, 18, and 24 months following the first dose of study drug;
    • Proportion of patients receiving rescue treatment; and
    • SF-36 quality of life assessment
    Los criterios secundarios de valoración de la eficacia para el análisis final son:
    - tiempo transcurrido desde la primera dosis del fármaco del estudio hasta la instauración por primera vez de diálisis de mantenimiento durante un mínimo de 1 mes, la realización de un trasplante renal o la aparición de insuficiencia renal definida como una FGe mantenida < 15 ml/min/1,73 m2, o el fallecimiento del paciente por la insuficiencia renal;
    - valores de CPCO, CACO y FGe (CKD-EPI) en comparación con el periodo basal promediados a lo largo de distintos momentos de evaluación entre los 12 y los 24 meses (inclusive) después de la primera dosis del fármaco del estudio;
    - tiempo transcurrido hasta una reducción del 40 % respecto al periodo basal en la FGe (CKDEPI) confirmada mediante un segundo valor obtenido en un plazo de 30 días a 100 días;
    - tiempo transcurrido hasta una reducción del 50 % respecto al periodo basal en la FGe (CKDEPI) confirmada mediante un segundo valor obtenido en un plazo de 30 días a 100 días;
    - porcentaje de pacientes con un nivel de proteinuria total menor o igual a 1 g/24 horas o CPCO menor de 0,8 g/gramo a los 12, 18 y 24 meses de la primera dosis del fármaco del estudio, y en la última visita del estudio;
    - porcentaje de pacientes con proteinuria menor o igual a 1 g/24 horas o CPCO menor de 0,8 g/gramo en al menos 2 de los siguientes momentos de evaluación: 12, 18 y 24 meses después de la primera dosis delfármaco del estudio;
    - porcentaje de pacientes sin microhematuria a los 12, 18 y 24 meses de la primera dosis del fármaco del estudio, y en la última visita del estudio;
    - porcentaje de pacientes sin microhematuria en al menos 2 de los siguientes momentos de evaluación: 12, 18 y 24 meses después de la primera dosis del fármaco del estudio;
    - porcentaje de pacientes que reciben tratamiento de rescate; y
    - evaluación de la calidad de vida mediante el cuestionario abreviado SF-36 (Short Form 36).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Ratio of UPCR, UACR, and eGFR (CKD-EPI): between 12 and 24 months
    - 40% reduction in eGFR (CKD-EPI): a second value obtained within 30 days to 100 days;
    - 50% reduction in eGFR (CKD-EPI): a second value obtained within 30 days to 100 days;
    - Proportion of patients with a total proteinuria level 1 g per 24 hours or UPCR 0.8 g/gram at 12, 18, and 24 months following the first dose of study drug, and at the last study visit
    - Patients without microhematuria:12,18, and 24 months and at the last study visit;
    - valores de CPCO, CACO y FGe (CKD-EPI): entre los 12 y los 24 meses
    - reducción del 40 % en la FGe (CKDEPI):segundo valor obtenido en un plazo de 30 días a 100 días;
    - reducción del 50 % en la FGe (CKDEPI):segundo valor obtenido en un plazo de 30 días a 100 días;
    - porcentaje de pacientes con un nivel de proteinuria total menor o igual a 1 g/24 horas o CPCO menor de 0,8 g/gramo s: a los 12, 18 y 24 meses
    - porcentaje de pacientes sin microhematuria a las 12, 18 y 24 meses
    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 Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    Argentina
    Australia
    Belarus
    Belgium
    Canada
    Czech Republic
    Finland
    France
    Germany
    Greece
    Italy
    Korea, Republic of
    Poland
    Spain
    Sweden
    Taiwan
    Turkey
    United Kingdom
    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
    The end of the study is defined as the date of the last subject's last
    visit.
    Definida como la fecha de la última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days26
    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: 410
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 219
    F.4.2.2In the whole clinical trial 450
    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)
    None
    Ninguno
    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 Decision2018-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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