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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-002349-23
    Sponsor's Protocol Code Number:8232-CL-0004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-002349-23
    A.3Full title of the trial
    A Phase 2, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of ASP8232 as Add-On Therapy to Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) in Reducing Albuminuria in Patients with Type 2 Diabetes and Chronic Kidney Disease.
    Estudio en fase II, doble ciego, randomizado y controlado con placebo para evaluar la eficacia y la seguridad de ASP8232 como tratamiento complementario del inhibidor de la enzima conversora de la angiotensina (IECA) o del antagonista del receptor de la angiotensina (ARA) en la reducción de la albuminuria en pacientes con diabetes de tipo 2 y nefropatía crónica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate efficacy and safety of ASP8232 as add-on therapy to the standard of care in patients with Type 2 Diabetes and Chronic Kidney Disease.
    Estudio para evaluar la eficacia y la seguridad de ASP8232 como tratamiento complementario en pacientes con diabetes de tipo 2 y nefropatía crónica
    A.3.2Name or abbreviated title of the trial where available
    ALBUM
    ALBUM
    A.4.1Sponsor's protocol code number8232-CL-0004
    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 SponsorAstellas Pharma Europe BV (APEB)
    B.1.3.4CountryNetherlands
    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 supportAstellas Pharma Europe BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace Spain, S.L.
    B.5.2Functional name of contact pointMonica Bermejo
    B.5.3 Address:
    B.5.3.1Street AddressAntonio Maura 16, 5 izquierda
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28014
    B.5.3.4CountrySpain
    B.5.4Telephone number003491853 41 055050
    B.5.5Fax number0034900981 853
    B.5.6E-mailm.bermejo@medpace.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 nameASP8232
    D.3.2Product code ASP8232
    D.3.4Pharmaceutical form 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 INNASP8232
    D.3.9.2Current sponsor codeASP8232
    D.3.9.3Other descriptive nameAS2658232-PH, VAP-823
    D.3.9.4EV Substance CodeSUB91888
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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, 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
    Diabetic nephropathy
    diabetes de tipo 2 y nefropatía crónica
    E.1.1.1Medical condition in easily understood language
    Diabetic nephropathy is chronic kidney disease or damage that can occur in people with diabetes mellitus.
    Nefropatía diabética es una enfermedad renal crónica o daño que puede ocurrir en personas con diabetes mellitus.
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10061835
    E.1.2Term Diabetic nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of ASP8232 in reducing Urinary Albumin to Creatinine Ratio (UACR) in subjects with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD) at 12 weeks compared to placebo.
    Evaluar la eficacia de ASP8232 en la reducción del cociente de albúmina/creatinina en orina (CACO) en pacientes que padecen diabetes mellitus de tipo 2 (DT2) y nefropatía crónica (NC) a las 12 semanas, en comparación con el placebo.
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of ASP8232 in reducing the 24h urinary albumin excretion rate (AER) in patients with T2DM and CKD at 12 weeks compared to placebo
    2. To evaluate the safety and tolerability of ASP8232 in patients with T2DM and CKD
    3. To evaluate the pharmacokinetics (PK) of ASP8232 in patients with T2DM and CKD
    4. To evaluate pharmacodynamics (PD) of ASP8232 by assessing vascular adhesion protein-1 (VAP-1) plasma concentration and inhibition of VAP-1 activity and total antioxidant status (TAS) in serum
    1.Evaluar la eficacia de ASP8232 en la reducción de la tasa de excreción urinaria (TEA) de la albúmina en la orina de 24 horas.
    2.Evaluar la seguridad y la tolerabilidad de ASP8232.
    3.Evaluar la farmacocinética (FC) de ASP8232.
    4.Evaluar la farmacodinamia (FD) de ASP8232, mediante la evaluación de la concentración plasmática de la proteína de adhesión vascular de tipo 1 (VAP-1), la inhibición de la actividad de la VAP-1 y el estado antioxidante total (EAT) en suero
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subject who is > 18 and < 85 years of age.
    2. Subject must have a eGFR (based on the CKD-EPI equation) at screening of ? 30 and < 60 mL/min/1.73m2.
    3. Subject must have a documented diagnosis of T2DM and received anti-diabetic medication (oral and/or insulin) for at least one year prior to screening.
    4. Subject?s HbA1c level is < 11.0% at screening.
    5. Subject is on a stable therapy with an ACE inhibitor or ARB for at least three months prior to screening.
    6. Subject who receives anti-hypertensive treatment, oral anti-diabetic agents and/or vitamin D receptor activators at screening needs to be on stable therapy for at least three months prior to screening.
    7. Subject?s UACR is ? 200 and ? 3000 mg/g at screening.
    1.Antes de someter a los pacientes a ningún procedimiento relacionado con el estudio (inclusive la retirada de los medicamentos prohibidos, si procede), se obtendrá la firma del paciente del Documento de consentimiento informado y el documento sobre confidencialidad autorizados por escrito por el Comité Ético de Investigación Clínica según las normativas nacionales.
    2.Pacientes de ambos sexos, con edades comprendidas entre > 18 y < 85 años.
    3.El paciente debe presentar una TFGe (según la fórmula CKD-EPI [Chronic Kidney Disease Epidemiology Collaboration]) en el screening ? 30 y < 60 ml/min/1,73 m2.
    4.El paciente debe tener un diagnóstico documentado de DT2 y haber recibido tratamiento antidiabético (oral y/o insulina) durante un mínimo de un año antes del screening.
    5.La concentración de HbA1c del paciente debe ser < 11,0 % (97 mmol/mol) en el screening.
    6.El paciente está en tratamiento estable con un IECA o un ARA durante un mínimo de tres meses antes del screening.
    7.El paciente que esté recibiendo un tratamiento antihipertensor, antidiabéticos orales y/o agonistas de los receptores de la vitamina D en el momento del screening debe estar en tratamiento estable durante un mínimo de tres meses antes del screening.
    8.Si el paciente se ha sometido a intervenciones nutricionales específicas, estas deberán haber sido estables durante los tres meses previos a la visita del screening.
    9.El CACO del paciente es ? 200 y ? 3000 mg/g en el momento del screening en una muestra de la POM.
    10.Las pacientes deben:
    ?No ser fértiles:
    ?Estar en la posmenopausia (definida como 1 año como mínimo sin menstruación) antes del screening.
    ?O ser estériles quirúrgicamente o haberse sometido a una histerectomía (1 mes como mínimo antes del screening).
    ?O, Ssi son fértiles:
    ?Dar negativo en la prueba de embarazo en orina en el screening.
    ?EO emplear dos tipos de método anticonceptivo* (siendo uno de ellos un método de barrera) desde el momento del screening, durante todo el estudio y durante los 28 días posteriores a la última administración del fármaco del estudio.
    11.Las pacientes no deberán estar en el período de lactancia en el momento del screening ni durante el estudio, así como tampoco durante los 28 días posteriores a la última administración del fármaco del estudio.
    12.Las pacientes no deberán donar óvulos desde el momento del screening ni durante el estudio, así como tampoco durante los 28 días posteriores a la última administración del fármaco del estudio.
    13.El paciente acuerda no participar en ningún otro estudio de intervención después de haber firmado el documento de consentimiento informado y hasta que haya concluido la visita de finalización del estudio.
    14.El paciente debe poseer la capacidad de, a juicio del Investigador, y la disposición a acudir a todas las visitas programadas y someterse a todas las evaluaciones.
    * Entre los métodos anticonceptivos aceptables se incluyen los siguientes:
    ?Empleo establecido de métodos anticonceptivos hormonales orales, inyectables o implantados.
    ?Implantación de un dispositivo intrauterino (DIU) o un sistema intrauterino (SIU).
    ?Métodos anticonceptivos de barrera: preservativo o capuchón oclusivo (diafragma o capuchón cervical) junto con espermicida (en espuma, gel, película, crema o supositorio).
    E.4Principal exclusion criteria
    1. Subject is on, or previously received, renal replacement therapy (e.g. dialysis or kidney transplantation).
    2. Subject has obstructive uropathy or other causes of renal impairment not related to parenchymal renal disorder and/or disease of the kidney; or subject currently has or has had in the past renal disease secondary to malignancy.
    3. Subject?s renal impairment and/or albuminuria is considered to be of other origin than Diabetic Kidney Disease
    4. Subject has known (auto-) immune disorder and/or received immunosuppression for more than two weeks, cumulatively, within 12 weeks prior to screening or anticipated need for immuno-suppressive therapy during the study
    5. Subject has active urinary tract infection which requires treatment or clinically significant infection at the time of screening or randomization
    6. Subject is diagnosed with type 1 diabetes mellitus or diabetes mellitus with unclear etiology.
    7. Subject has a supine systolic blood pressure (SBP) <90 or >160 mmHg and/or a diastolic blood pressure (DBP) >90 mmHg at screening.
    1.Pacientes que hayan recibido un tratamiento en fase de investigación clínica en los 28 días previos al screening.
    2.Pacientes que padezcan otras dolencias que, a juicio del investigador, imposibiliten la participación del paciente en el estudio.
    3.Pacientes que estén o hayan estado con anterioridad en tratamiento renal sustitutivo (p. ej., diálisis o trasplante de riñón).
    4.Pacientes que padezcan una uropatía obstructiva u otras causas de una insuficiencia renal que no esté relacionada con un trastorno renal parenquimatoso y/o una nefropatía; o pacientes que padezcan o hayan padecido en el pasado una nefropatía secundaria a una neoplasia maligna.
    5.Pacientes cuya insuficiencia renal y/o albuminuria se considere que no es secundaria a la nefropatía diabética.
    6.Pacientes que padezcan una enfermedad (auto)inmunitaria conocida y/o estén recibiendo un tratamiento inmunodepresor durante más de dos semanas, de forma acumulativa, en las 12 semanas previas al screening o se prevea que vaya a necesitar un tratamiento inmunodepresor durante el estudio.
    7.Pacientes que presenten una infección activa de las vías urinarias que precise tratamiento o una infección clínicamente significativa en el momento del screening o la randomización.
    8.Pacientes a los que se les diagnostique una diabetes de tipo 1 o una diabetes con una etiología confusa .
    9.Pacientes que presenten una tensión arterial sistólica (TAS) en decúbito supino < 90 o > 160 mm Hg o una tensión arterial diastólica (TAD) > 90 mm Hg en el momento del screening.
    10.Pacientes embarazadas, en período de lactancia o que den positivo en la prueba de embarazo en las 72 horas previas al screening y/o la randomización o hayan estado embarazas en los 6 meses previos a la evaluación del screening o en el período de lactancia en los 3 meses previos al screening o que tengan previsto quedarse embarazadas en los 9 meses posteriores al screening.
    11.Pacientes que tengan o se sospeche que tienen hipersensibilidad a ASP8232 o a alguno de los excipientes de la forma farmacéutica empleada.
    12.Pacientes que sean empleados de Astellas Group o de la CRO implicada en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change of log transformed UACR from baseline to end of treatment.
    Variación media del CACO transformado logarítmicamente desde el inicio hasta el final del tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    As per schedule of assessments described in the protocol.
    De acuerdo con el calendario de las evaluaciones descritas en el protocolo.
    E.5.2Secondary end point(s)
    ? Mean change of log transformed UACR over time of treatment using the repeated measurements method from baseline to end of treatment.
    ? The proportion of subjects with >30%/40%/50% reduction in UACR from baseline to end of treatment
    ? Mean change of log transformed AER from baseline to end of treatment
    ? The proportion of subjects with >30%/40%/50% reduction in AER from baseline to end of treatment
    ?Variación media del CACO transformado logarítmicamente desde el inicio hasta el final del tratamiento
    ?Porcentaje de pacientes con una reducción del CACO > 30 %/40 %/50 % desde el inicio hasta el final del tratamiento.
    ?Variación media de la TEA transformada logarítmicamente desde el inicio hasta el final del tratamiento.
    ?Porcentaje de pacientes con una reducción de la TEA > 30 %/40 %/50 % desde el inicio hasta el final del tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As per schedule of assessments described in the protocol.
    De acuerdo con el calendario de las evaluaciones descritas en el protocolo.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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 trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS_ la ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    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 Decision2015-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
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