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    Summary
    EudraCT Number:2018-004079-11
    Sponsor's Protocol Code Number:D5495C00002
    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:2019-06-11
    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 number2018-004079-11
    A.3Full title of the trial
    A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients with Chronic Kidney Disease and Hyperuricaemia
    Estudio de fase IIb, multicéntrico, aleatorizado, doble ciego y controlado con placebo de verinurad y alopurinol en pacientes con nefropatía crónica e hiperuricemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IIb trial to find out the effectiveness and safety of verinurad and allopurinol in patients with chronic kidney disease and elevated serum uric acid.
    Estudio de fase IIb para descubrir la eficacia y seguridad de verinurad and allopurinol en pacientes con enfermedad renal crónica y niveles elevados de ácido úrico.
    A.3.2Name or abbreviated title of the trial where available
    SAPPHIRE
    SAPPHIRE
    A.4.1Sponsor's protocol code numberD5495C00002
    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 SponsorAstraZeneca 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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike
    B.5.3.2Town/ cityWilmington DE
    B.5.3.3Post code19803
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@astrazeneca.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 nameVerinurad 3mg
    D.3.2Product code RDEA3170
    D.3.4Pharmaceutical form Capsule
    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 INNVerinurad
    D.3.9.1CAS number 1352792-74-5
    D.3.9.3Other descriptive nameRDEA3170
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVerinurad 7.5 mg
    D.3.2Product code RDEA3170
    D.3.4Pharmaceutical form Capsule
    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 INNVerinurad
    D.3.9.1CAS number 1352792-74-5
    D.3.9.3Other descriptive nameRDEA3170
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVerinurad 12 mg
    D.3.2Product code RDEA3170
    D.3.4Pharmaceutical form Capsule
    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 INNVerinurad
    D.3.9.1CAS number 1352792-74-5
    D.3.9.3Other descriptive nameRDEA3170
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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.IMP: 4
    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 Yes
    D.2.1.1.1Trade name Allopurinol
    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 nameAllopurinol 100mg
    D.3.4Pharmaceutical form Tablet
    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 INNAllopurinol
    D.3.9.1CAS number 315-30-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.IMP: 5
    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 Yes
    D.2.1.1.1Trade name Allopurinol
    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 nameAllopurinol 200mg
    D.3.4Pharmaceutical form Tablet
    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 INNAllopurinol
    D.3.9.1CAS number 315-30-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 6
    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 Yes
    D.2.1.1.1Trade name Allopurinol
    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 nameAllopurinol 300mg
    D.3.4Pharmaceutical form Tablet
    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 INNAllopurinol
    D.3.9.1CAS number 315-30-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Chronic kidney disease and hyperuricaemia
    Nefropatía crónica e hiperuricemia
    E.1.1.1Medical condition in easily understood language
    Chronic kidney disease and elevated serum uric acid
    Enfermedad renal crónica y alto nivel de ácido úrico.
    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
    To assess the effects of treatment with verinurad and allopurinol, allopurinol alone, and placebo on UACR at 6 months
    Evaluar los efectos del tratamiento con verinurad y alopurinol, alopurinol como monoterapia y placebo sobre el valor del CACO a los 6 meses.
    E.2.2Secondary objectives of the trial
    To assess the effects of treatment with verinurad and allopurinol, allopurinol alone, and placebo on UACR at 12 months
    To assess the effects of verinurad and allopurinol, allopurinol alone, and placebo on sUA
    To estimate the dose-response relationship among 3 doses of verinurad and allopurinol and placebo on UACR and sUA
    To assess the effects of verinurad and allopurinol versus placebo on kidney function.
    Evaluar los efectos del tratamiento con verinurad y alopurinol, alopurinol como monoterapia y placebo sobre el valor del CACO a los 12 meses.
    Evaluar los efectos del tratamiento con verinurad y alopurinol, alopurinol como monoterapia y placebo sobre la concentración de AUs.
    Calcular la relación dosis-respuesta entre 3 dosis de verinurad y alopurinol y placebo sobre los valores de CACO y AUs.
    Evaluar los efectos de verinurad y alopurinol frente al placebo en la función 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
    MRI sub-study
    PK sub-study
    vascular reactivity sub-study
    Subestudio de Resonancia Magnetica (RM).
    Subestudio de Farmatocinética (PK).
    Subestudio de reactividad vascular.
    E.3Principal inclusion criteria
    - Provision of signed and dated, written ICF.
    - Provision of signed and dated written genetic informed consent prior to collection of sample for genetic analysis
    - Patient must be ≥18 years of age at the time of signing the ICF.
    - CKD as defined in the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines; ie, there must be a documented occurrence at least 3 months before randomisation of eGFR <60 mL/min/1.73 m2, UACR ≥30 mg/g, and/or other markers of kidney damage (including urine protein dipstick ≥1+, positive urine albumin dipstick, or urinary protein to creatinine ratio ≥84 mg/g)
    - Patients should receive background standard of care treatment for albuminuria and/or T2DM and be treated according to locally recognised guidelines, as appropriate. Guideline-recommended medications should be used at recommended doses. Therapy should have been optimised and stable for ≥4 weeks before study entry and include an ACEi or an ARB, unless contraindicated, not tolerated, or in the opinion of the investigator not practically available or suitable.
    - If treated with a sodium-glucose transport protein (SGLT2) inhibitor, the SGLT2 inhibitor dose must have been stable for ≥4 weeks before randomisation.
    - Meeting screening criteria for sUA and eGFR (Visit 2)
    (a) sUA ≥6.0 mg/dL
    (b) eGFR ≥25 mL/min/1.73 m2 (CKD-EPI formula)
    - Mean UACR between 30 mg/g and 5000 mg/g inclusive. At least 2 first morning void samples collected before randomisation will be required.
    - Male or female
    -Entrega de un FCI por escrito firmado y fechado.
    -Entrega de un FCI de muestras genética por escrito firmado y fechado antes de la recogida de muestras en análisis genéticos.
    -El paciente debe tener ≥18 años de edad en el momento de la firma del FCI.
    -NFC, tal como se define en la nefropatía: Pautas de mejora de resultados clínicos globales (KDIGO); por ejemplo, debe estar documentada la presencia de valores de VFGe <60 ml/min/1,73 m2, CACO ≥30 mg/g al menos tres meses antes de la aleatorización y/u otros marcadores de lesión renal (incluida prueba de proteína en orina con tira reactiva ≥1+, albúmina positiva en orina mediante prueba con tira reactiva o cociente de proteína:creatinina en orina ≥84 mg/g).
    -Los pacientes deben recibir el tratamiento de referencia de base para la albuminuria y/o la DMT2 y ser tratados conforme a las directrices reconocidas localmente, según corresponda. Se deben usar los medicamentos recomendados en las directrices en las dosis recomendadas. El tratamiento debe estar optimizado y estable durante ≥ 4 semanas antes de la inclusión en el estudio y debe incluir un IECA o BRA, salvo que esté contraindicado, o que según el criterio del investigador no sea práctico o adecuado.
    -Si recibe un inhibidor de la proteína transportadora de sodio-glucosa (SGLT2), la dosis de este inhibidor debe haberse mantenido estable durante ≥4 semanas antes de la aleatorización.
    -Cumplir los criterios de selección para AUs y la VFGe (consulta 2)
    (a) AUs ≥6,0 mg/dl
    (b) VFGe ≥25 ml/min/1,73 m2 (fórmula EPI para la NFC)
    -CACO medio entre 30 mg/g y 5000 mg/g (ambos inclusive). Es obligatorio obtener al menos 2 muestras de orina de la primera micción de la mañana antes de la aleatorización.
    -Hombre o mujer
    E.4Principal exclusion criteria
    - Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
    - History of renal transplantation
    - Known carrier of the (HLA-B) *58:01 allele.
    - Patients diagnosed with tumor lysis syndrome or Lesch-Nyhan syndrome
    - History of stroke, myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft in the past 6 months
    - Uncontrolled hypertension presenting with systolic blood pressure >180 mm Hg and/or diastolic blood pressure >100 mm Hg
    - Diagnosed with heart failure and (NYHA) Class IV at the time of randomisation
    - QT interval corrected by the Fridericia formula (QTcF) >470 msec; patients diagnosed with long QT syndrome; patients with a family history of long QT syndrome
    - Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
    - Treated with any drug for hyperuricaemia in the 6 months preceding randomisation.
    - Dose of ACEi, ARBs, fenofibrate, guaifenesin, or SGLT2 inhibitors changed within 4 weeks of randomisation or further dose titration expected after randomisation
    - Treated with strong or moderate (OATP) inibitors
    - Participation in another clinical study with an investigational product administered during the last month prior to randomisation
    - Patients who are pregnant, lactating, or planning to become pregnant.
    - Nefropatía poliquística autosómica recesiva o dominante autosómica, nefritis lúpica o vasculitis asociada con anticuerpos citoplasmáticos antineutrófilos (ACAN).
    - Antecedentes de trasplante renal.
    - Portador conocido del alelo 58:01 del antígeno B leucocitario humano (HLA-B).
    - Los pacientes diagnosticados con síndrome de lisis tumoral o síndrome de Lesch-Nyhan.
    - Antecedentes de ictus, infarto de miocardio, intervención coronaria percutánea, derivación de la arteria coronaria en los últimos 6 meses.
    - Hipertensión controlada inadecuadamente (definida como tensión arterial sistólica >180 mmHg y/o tensión arterial diastólica >100 mgHg).
    - Intervalo QT corregido según la fórmula de Fridericia (QTcF) >470 mseg. Pacientes diagnosticados con síndrome de intervalo QT largo. Pacientes con antecedentes familiares de síndrome de intervalo QT largo.
    - Haber recibido tratamiento citotóxico, inmunodepresor u otra inmunoterapia para nefropatía primaria o secundaria en los 6 meses previos a la inscripción.
    - Tratamiento con cualquier medicamento para la hiperuricemia en los 6 meses previos a la aleatorización.
    - Modificación de la dosis de IECA, BRA, fenofibrato, guaifenesina o inhibidores de SGLT2 en las 4 semanas previas a la aleatorización o cuando se prevé un mayor ajuste de la dosis después de la aleatorización.
    - Tratamiento con inhibidores fuertes o moderados del polipéptido transportador aniónico (OATP)
    - Participación en otro estudio clínico con un producto en fase de investigación administrado durante el último mes previo a la aleatorización.
    - Pacientes que estén embarazadas o dando el pecho o que tengan pensando quedarse embarazadas.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in UACR at 6 months
    Variación en el valor del CACO a los 6 meses respecto al inicio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline at 6 months
    A los 6 meses desde el inicio.
    E.5.2Secondary end point(s)
    • Change from baseline in UACR at 12 months, end of treatment and end of study
    • Change from baseline in sUA at 6 and 12 months, end of treatment and end of study
    • Change from baseline in estimated glomerular filtration rate at 6 and 12 months, end of treatment and end of study
    • Change from baseline in creatinine at 6 and 12 months, end of treatment and end of study
    • Change from baseline in cystatin-C at 6 and 12 months end of treatment and end of study
    • Variación en el valor del CACO a los 12 meses, fin del tratamiento y fin del estudio.
    • Variación en la concentración de AUs a los 6 y 12 meses, fin del tratamiento y fin del estudio.
    • Variación en la velocidad de filtración glomerular estimada a los 6 y 12 meses, fin del tratamiento y fin del estudio.
    • Variación en la concentración de creatinina a los 6 y 12 meses, fin del tratamiento y fin del estudio.
    • Variación en la concentración de cistatina-C a los 6 y 12 meses, fin del tratamiento y fin del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • From baseline at 12 months, end of treatment and end of study
    • From baseline at 6 and 12 months, end of treatment and end of study
    • From baseline at 6 and 12 months, end of treatment and end of study
    • From baseline at 6 and 12 months, end of treatment and end of study
    • From baseline at 6 and 12 months, end of treatment and end of study
    • A los 12 meses desde el inicio, fin del tratamiento y fin del estudio.
    • A los 6 y 12 meses desde el inicio, fin del tratamiento y fin del estudio.
    • A los 6 y 12 meses desde el inicio, fin del tratamiento y fin del estudio.
    • A los 6 y 12 meses desde el inicio, fin del tratamiento y fin del estudio.
    • A los 6 y 12 meses desde el inicio, fin del tratamiento y fin del estudio.
    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 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Allopurinol
    Allopurinol
    E.8.2.4Number of treatment arms in the trial5
    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 concerned21
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA107
    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
    Czech Republic
    France
    Hungary
    Israel
    Italy
    Mexico
    Poland
    Romania
    Slovakia
    South Africa
    Spain
    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 study is defined as the last expected visit/contact of the last patient undergoing the study.
    El final del estudio se define como la última visita/contacto previsto del último paciente del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 425
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state97
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 349
    F.4.2.2In the whole clinical trial 725
    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)
    After the end of the study patients will be treated at the responsible physician’s discretion.
    Una vez finalizado el estudio, los pacientes serán tratados a discreción del médico 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 Decision2019-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-25
    P. End of Trial
    P.End of Trial StatusOngoing
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