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    Summary
    EudraCT Number:2010-022297-14
    Sponsor's Protocol Code Number:402-C-0903
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-08-19
    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 number2010-022297-14
    A.3Full title of the trial
    Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: The Occurrence of Renal Events (BEACON)
    Estudio de Bardoxolona metilo en pacientes con enfermedad renal crónica y diabetes tipo 2: aparición de episodios renales (BEACON)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Evaluation of Bardoxolone Methyl in Patients with Chronic Kidney Disease and Type 2 Diabetes
    Evaluación de Bardoxolona metilo en pacientes con enfermedad renal crónica y diabetes tipo 2
    A.3.2Name or abbreviated title of the trial where available
    BEACON
    BEACON (del inglés)
    A.4.1Sponsor's protocol code number402-C-0903
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01351675
    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 SponsorReata Pharmaceuticals, Inc
    B.1.3.4CountryUnited States
    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 supportReata Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportAbbott Laboratories
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbott Laboratories
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628644475
    B.5.5Fax number+441628644330
    B.5.6E-maileuclinicaltrials@abbott.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 nameBardoxolone methyl
    D.3.2Product code RTA-402
    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 INNbardoxolone methyl
    D.3.9.1CAS number 218600-53-4
    D.3.9.2Current sponsor codeRTA 402
    D.3.9.3Other descriptive nameCDDO-Me, CDDO-Methyl Ester, NSC 713200
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Chronic Kidney Disease Stage 4
    Enfermedad Renal Crónica Estadío IV
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney Disease
    Enfermedad Renal Crónica
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10038359
    E.1.2Term Renal and urinary disorders
    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 assess the efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease (ESRD) and cardiovascular death in patients with Stage 4 CKD and type 2 diabetes receiving standard of care
    Evaluar la eficacia de Bardoxolona metilo respecto al placebo para retrasar el avance la enfermedad renal terminal (ERT) y muerte cardiovascular en pacientes con ERC en estadio IV y diabetes tipo 2 que estén recibiendo tratamiento de referencia habitual.
    E.2.2Secondary objectives of the trial
    To assess the safety of bardoxolone methyl relative to placebo in patients with Stage 4 CKD and type 2 diabetes receiving standard of care
    Evaluar la seguridad de Bardoxolona metilo respecto al placebo en pacientes con ERC en estadio IV y diabetes tipo 2 que estén recibiendo tratamiento de referencia habitual.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Screening eGFR ? 15.0 and < 30.0 mL/min/1.73 m2; screening eGFR will be the average of the eGFR values collected during screening;
    2. A history of type 2 diabetes; diagnosis should have been made at ? 30 years of age (if diabetes developed at a younger age, C-peptide level must confirm type 2 diabetes);
    3. Male or female patients at least 18 years of age;
    4. Treatment with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) for at least 6 weeks prior to Screening Visit A and during screening. The dosage of ACE inhibitor and/or ARB must be stable for 2 weeks prior to Screening Visit A and during screening (i.e., no change in dosage or medication). Patients not taking an ACE inhibitor and/or ARB, or taking an ACE inhibitor and/or ARB at levels below the goal dose set by K/DOQI guidelines (See Appendix A) should have a documented medical contraindication (e.g., hyperkalemia, dry cough, angioedema), which the investigator must discuss with the appropriate medical monitor;
    5. Mean systolic blood pressure (SBP) must be ? 160 mmHg and ? 105 mmHg and mean diastolic blood pressure (DBP) must be < 90 mmHg during screening; both mean SBP and mean DBP (determined as the average of three readings) must be within the described range at two separate time points, which must occur at least 4 days apart during the screening period;
    1. FGe (filtración glomerular estimada) en el screening ? 15,0 y < 30,0 ml/min/1,73 m2; la FGe del screening será la media de los valores FGe recogidos durante el screening;
    2. Antecedentes médicos de diabetes tipo 2; el diagnóstico se deberá haber realizado a partir de los 30 años de edad (en el caso de que la diabetes se hubiera presentado a una edad más temprana, la diabetes tipo 2 se confirmará con el nivel de péptido C en ayunas);
    3. Pacientes de ambos sexos mayores de 18 años.
    4. Tratamiento con un inhibidor de la enzima conversora de la angiotensina (IECA) y/o un antagonista del receptor de la angiotensina II (ARA II), durante 6 semanas como mínimo antes de la Visita A del screening y durante el screening. La dosis del IECA y/o el ARA II debe mantenerse durante las 2 semanas previas a la Visita A del screening y durante el screening (es decir, la dosis o la medicación no se debe cambiar). Aquellos pacientes que no estén tomando un IECA y/o un ARA-II, o que estén tomando unas dosis de IECA y/o un ARA-II inferiores a la dosis establecida por la KDOQI (Kidney Foundation Kidney Disease Outcomes Quality Initiative de EE. UU.; véase el Anexo A) deberán tener un historial registrado de contraindicaciones médicas (p. ej., hiperpotasemia, tos seca o angioedema) y el investigador deberá evaluarlo con el monitor médico correspondiente.
    5. La tensión arterial sistólica media (TAS) debe ser ? 160 mm Hg y ? 105 mm Hg y la tensión arterial diastólica (TAD) debe ser ? 90 mm Hg durante el screening; tanto la TAS media como la TAD media (determinadas como la media de tres lecturas) deben estar comprendidas dentro del intervalo descrito en dos visitas separadas y con al menos 4 días de diferencia durante el período de screening.
    E.4Principal exclusion criteria
    1. Type 1 diabetes mellitus (juvenile onset). If a history of diabetic ketoacidosis exists, a C-peptide level must confirm type 2 diabetes;
    2. Known non-diabetic renal disease (e.g., known polycystic kidney disease or family history of a hereditary form of kidney disease) [nephrosclerosis superimposed on diabetic kidney disease is acceptable];
    3. Ongoing clinical investigation with evidence (e.g., unexplained hematuria or red blood cell or white blood cell casts) suggesting non-diabetic renal disease other than nephrosclerosis;
    4. History of a renal transplant or a planned transplant from a living donor during the study;
    5. Albumin to creatinine ratio (ACR) at Screening Visit B greater than 3500 mg/g;
    6. Hemoglobin A1c level > 11.0% (97 mmol/mol) during screening;
    7. Acute dialysis or acute kidney injury within 12 weeks prior to screening or during screening;
    8. Clinical signs and/or symptoms of uremia and expected need for renal replacement therapy within 12 weeks following randomization, as assessed by the investigator;
    9. Recently active cardiovascular disease defined as:
    ? Unstable angina pectoris within 12 weeks before study randomization;
    ? Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 12 weeks before study randomization;
    ? Cerebrovascular accident, including transient ischemic attack within 12 weeks before study randomization;
    ? Current diagnosis of Class III or IV NYHA congestive heart failure (Appendix B);
    10. Clinical diagnosis of severe obstructive valvular heart disease or severe obstructive hypertrophic cardiomyopathy;
    11. Atrioventricular block, 2o or 3o, not successfully treated with a pacemaker;
    12. Diagnostic or interventional procedure that required a contrast agent within 30 days prior to study randomization or planned during the study;
    13. Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study;
    14. Total bilirubin, aspartate transaminase (AST), or alanine transaminase (ALT) level greater than the upper limit of normal (ULN) or alkaline phosphatase level greater than two times the ULN on ANY screening laboratory test result;
    15. Female patients who are pregnant, intend to become pregnant during the study, or are nursing;
    16. BMI < 18.5 kg/m2;
    17. Known hypersensitivity to any component of the study drug;
    18. Current history of drug or alcohol abuse, as assessed by the investigator;
    19. Clinically significant infection requiring intravenous administration of antibiotics or hospitalization within 6 weeks prior to Screening Visit A or during screening;
    20. Diagnosis or treatment of a malignancy in the past 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix;
    1. Diabetes mellitus tipo 1 (juvenil). Si existen antecedentes de cetoacidosis diabética, la diabetes tipo 2 deberá confirmarse con los niveles de péptido C en ayunas.
    2. Enfermedad renal no diabética conocida (p. ej., enfermedad renal poliquística conocida o antecedentes familiares de una enfermedad renal hereditaria). [Se admite la nefroesclerosis sobreimpuesta a enfermedad renal diabética].
    3. Investigación clínica en curso con datos (p. ej., hematuria idiopática o cilindros urinarios hemáticos [eritrocíticos o leucocíticos]) que apunten a una enfermedad renal no diabética que no sea una nefroesclerosis.
    4. Antecedentes de trasplante renal o un trasplante planificado de un donante vivo durante el estudio.
    5. Cociente albúmina/creatinina (CAC) superior a 3.500 mg/g en la Visita B del screening.
    6. Niveles de hemoglobina A1c > 11,0 % (97 mmol/mol) durante el screening;
    7. Diálisis aguda o insuficiencia renal aguda en las 12 semanas previas al screening o durante el mismo.
    8. Signos y/o síntomas clínicos de síndrome hiperurémico y posible requerimiento de diálisis en las 12 semanas siguientes a la randomización, según el criterio del investigador.
    9. Enfermedad cardiovascular activa reciente, definida como:
    ? Angina de pecho inestable en las 12 semanas previas a la randomización en el estudio.
    ? Infarto de miocardio, revascularización coronaria o angioplastia/endoprótesis coronaria transluminal percutánea en las 12 semanas previas a la randomización en el estudio.
    ? Accidente cerebrovascular, inclusive el accidente isquémico transitorio en las 12 semanas previas a la randomización en el estudio.
    ? Diagnóstico actual de insuficiencia cardíaca congestiva de clase III o IV de la NYHA (New York Heart Association) (Anexo B).
    10. Diagnóstico clínico de valvulopatía obstructiva grave o miocardiopatía hipertrófica obstructiva severa.
    11. Bloqueo auriculoventricular de 2.º o 3.er grado, con fracaso del tratamiento con marcapasos.
    12. Procedimiento diagnóstico o intervencionista que requiera un agente de contraste, en los 30 días previos a la randomización en el estudio o planificado durante el estudio.
    13. Inmunodepresión sistémica durante más de 2 semanas, de forma acumulativa, en las 12 semanas previas a la randomización o requerimiento previsto de inmunodepresión durante el estudio.
    14. Niveles de bilirrubina total, aspartato-aminotransferasa (ASAT) o alanina-aminotransferasa (ALAT) superiores al límite superior normal (LSN) o el nivel de fosfatasa alcalina superior al doble del LSN en CUALQUIER resultado de las pruebas analíticas de screening.
    15. Pacientes embarazadas, que tengan la intención de quedarse embarazadas durante el estudio o sean madres lactantes.
    16. IMC < 18,5 kg/m2.
    17. Hipersensibilidad conocida a cualquier componente del fármaco del estudio.
    18. Antecedentes médicos de drogodependencia o alcoholemia, según la valoración del investigador.
    19. Infecciones de importancia clínica que requieran la administración intravenosa de antibióticos o la hospitalización, en las 6 semanas previas a la Visita A del screening o durante el mismo.
    20. Diagnóstico o tratamiento de una neoplasia maligna en los últimos 5 años, excluyendo cáncer de piel no melanocítico y carcinoma in situ de cuello uterino.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first event of the composite endpoint consisting of:
    ? ESRD (need for chronic dialysis or renal transplantation)
    ? Cardiovascular death
    Tiempo hasta el primer acontecimiento de valoración, consistente en:
    ? ERT (requerimiento de diálisis crónica o trasplante renal).
    ? Muerte cardiovascular.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the trial
    A lo largo del estudio
    E.5.2Secondary end point(s)
    1. Rate of change in eGFR over the duration of study
    2. Tme to first hospitalization for heart failure
    3. Tme to first event of the composite endpoint consisting of:
    ? Non-fatal myocardial infarction
    ? Non-fatal stroke
    ? Hospitalization for heart failure
    ? Cardiovascular death
    1. Cambio en la FGe
    2. Tiempo hasta la primera hospitalización por insuficiencia cardíaca.
    3. Tiempo hasta el primer acontecimiento de valoración,consistente en:
    ? Infarto de miocardio no mortal.
    ? Ictus no mortal.
    ? Hospitalización por insuficiencia cardíaca.
    ? Muerte cardiovascular.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the trial
    A lo largo 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 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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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
    Australia
    Austria
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Israel
    Italy
    Mexico
    Spain
    Sweden
    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 trial is defined as the last subjects last scheduled visit or the actual date of the follow-up contact, whichever is longer
    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 months0
    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 months0
    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: 960
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 640
    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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 217
    F.4.2.2In the whole clinical trial 1600
    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)
    Patients who continue taking study drug until study completion will be considered for another study evaluating additional exposure to bardoxolone methyl.
    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 Decision2010-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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