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    Summary
    EudraCT Number:2012-005848-21
    Sponsor's Protocol Code Number:M11-352
    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:2013-10-22
    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 number2012-005848-21
    A.3Full title of the trial
    A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects with Type 2 Diabetes and Nephropathy SONAR: Study Of Diabetic Nephropathy with Atrasentan
    Ensayo multicéntrico internacional, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo del efecto de atrasentan sobre los resultados renales de sujetos con diabetes tipo 2 y nefropatía. SONAR: ensayo de nefropatía diabética con atrasentan
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Effects of Atrasentan (ABT-627) on Renal Outcomes in Subjects with Type 2 Diabetes and Nephropathy
    Ensayo del efecto de atrasentan sobre los resultados renales de sujetos con diabetes tipo 2 y nefropatía.
    A.3.2Name or abbreviated title of the trial where available
    SONAR
    SONAR
    A.4.1Sponsor's protocol code numberM11-352
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628644475
    B.5.5Fax number+441628644330
    B.5.6E-maileu-clinical-trials@abbvie.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 nameAtrasentan
    D.3.2Product code ABT-627
    D.3.4Pharmaceutical form Film-coated 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 INNAtrasentan
    D.3.9.1CAS number 195733-43-8
    D.3.9.2Current sponsor codeABT-627
    D.3.9.3Other descriptive nameATRASENTAN
    D.3.9.4EV Substance CodeSUB20598
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    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 placeboFilm-coated tablet
    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
    Nefropatia diabetica
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes and Nephropathy
    Diabetes tipo 2 y nefropatia
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    The study objective is to evaluate the effect of atrasentan compared with placebo on time to doubling of serum creatinine or the onset of end stage renal disease (ESRD) in type 2 diabetic subjects with nephropathy who are treated with the maximum tolerated labeled dose (MTLD) of a Renin Angiotensin System (RAS) inhibitor.
    el objetivo del ensayo es evaluar el efecto de atrasentan en comparación con el placebo en el tiempo de duplicación de la creatinina sérica o la aparición de enfermedad renal en fase terminal (ERT) en sujetos con diabetes tipo 2 y nefropatía que reciben tratamiento con la dosis máxima tolerada diaria indicada (MTLDD, por sus siglas en inglés) de un inhibidor del sistema renina angiotensina (SRA).
    E.2.2Secondary objectives of the trial
    The study will additionally assess the effects of atrasentan compared with placebo on cardiovascular morbidity and mortality, urine albumin excretion, changes in estimated glomerular filtration rate (eGFR), as well as on the impact on quality of life in type 2 diabetic subjects with nephropathy.
    Asimismo, el ensayo evaluará los efectos de atrasentan en comparación con el placebo en la morbimortalidad cardiovascular, la excreción de albúmina en orina y los cambios en la tasa de filtración glomerular estimada (TFGe), así como el impacto en la calidad de vida en los sujetos con diabetes tipo 2 y nefropatía.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - pharmacogenetic study
    - 24 hour urine study
    Estudio farmacogenético
    Estudio de recogida de orina de 24 horas
    E.3Principal inclusion criteria
    1. Subject has type 2 diabetes and has been treated with at least one anti-hyperglycemic medication and ACEi/or ARB (RAS inhibitor) for at least 3 months prior to the Screening Period.
    2. HbA1c ? 12%.
    3. For entry into the Run-In Period the subject must satisfy the following criteria based on the Screening laboratory values:
    ? Estimated GFR 25 to 75 mL/min/1.73 m2 and a UACR ? 300 and < 5,000 mg/g (The number of subjects with eGFR between 60 to 75 mL/min/1.73 m2 will be capped to 10% of the total population);
    ? Serum albumin ? 3.0 g/dL (30 g/L);
    ? BNP ? 200 pg/mL (200 ng/L);
    ? SBP > 110 and <160 mmHg;
    ? Serum Potassium > 3.5 (3.5 mmol/L) and ? 5.5 mEq/L (5.5 mmol/L);
    Subjects on a MTLDD of a RAS inhibitor for ? 4 weeks and on a diuretic at the time of screening and who satisfy the above criteria may proceed to the last visit in Run-In Period (R6);
    Subjects already on a MTLDD of a RAS inhibitor for ? 4 weeks and not on a diuretic (unless medically contraindicated) at the time of Screening will start with a diuretic and proceed to Run-In for at least 2 weeks.
    4. For entry into the Enrichment Period the subject must satisfy the following criteria based on the last visit of the Run-In Period:
    ? RAS inhibitor at the MTLDD for the previous 4 weeks with no adjustments of the dose;
    ? Subjects that were on a MTLDD RAS inhibitor and not on a diuretic (unless medically contraindicated) at the time of Screening must have been in Run-In for at least 2 weeks.
    5. For entry into the Double-Blind Treatment Period, the subject must satisfy the following criteria based on the last visit of the Enrichment Period:
    ? RAS inhibitor at the MTLDD for the previous 6 weeks during the Enrichment Period with no adjustments of the dose;
    ? Diuretic at any dose unless medically contraindicated or clinically intolerable in the investigator's judgement (i.e., hypotension or hypokalemia);
    ? Weight change < 3 kg and absolute serum BNP < 300 pg/mL (300 ng/L) at Enrichment Week 6 from the beginning of Enrichment;
    ? Subjects must not have an AKI event at the end of the Enrichment period, as defined by an increase from baseline in serum Creatinine > 0.5 mg/dL and > 20% increase at Enrichment Week 6 (visit E5) from baseline.
    1. El sujeto tiene diabetes tipo 2 y ha utilizado al menos un medicamento hipoglucemiante, e iECA o BRA (inhibidor del SRA) durante al menos 3 meses antes del período de selección. El sujeto no puede tener diabetes tipo 1, definido por una aparición antes de los 35 años, que haya requerido tratamiento crónico con insulina en los 12 meses siguientes al diagnóstico de la diabetes tipo 1.
    2. HbA1c ? 12%.
    3. Para entrar en el período de inclusión, el sujeto deberá satisfacer los siguientes criterios, basados en los valores de laboratorio en la selección:
    ? Tasa de filtración glomerular estimada de 25 a 75 ml/min/1,73 m2 y UACR ? 300 y < 5000 mg/g (la cantidad de sujetos con TFGe entre 60 y 75 ml/min/1,73 m2 se limitará al 10% de la población total);
    ? Albúmina sérica ? 3,0 g/dl (30 g/l);
    ? PNC ? 200 pg/ml (200 ng/l);
    ? PS > 110 y < 160 mmHg;
    ? Potasio sérico > 3,5 (3,5 mmol/l) y ? 5,5 meq/l (5,5 mmol/l);
    Los sujetos que reciban la dosis máxima tolerada diaria indicada de un inhibidor del SRA durante ? 4 semanas y diuréticos en el momento de la selección, y que satisfagan los criterios anteriores podrán continuar con la última visita del período de inclusión (R6);
    Los sujetos que ya reciban la dosis máxima tolerada diaria indicada de un inhibidor del SRA durante ? 4 semanas y no tomen diuréticos en el momento de la selección, comenzarán con un diurético (a menos que estén contraindicados desde el punto de vista médico) y pasarán a la inclusión durante 2 semanas como mínimo.
    4. Para entrar en el período de enriquecimiento, el sujeto deberá satisfacer los siguientes criterios, basados en la última visita del período de inclusión:
    ? Inhibidor del SRA a la MTLDD durante las 4 semanas previas sin ajuste de dosis;
    ? Los sujetos que recibían la MTLDD de un inhibidor del SRA y no tomaban diuréticos (a menos que estuviera contraindicado desde el punto de vista médico) en el momento de la selección, deben haber estado en inclusión durante al menos 2 semanas.
    5. Para entrar en el período de tratamiento doble ciego, el sujeto deberá satisfacer los siguientes criterios, basados en la última visita del período de enriquecimiento:
    ? Inhibidor del SRA a la MTLDD en las 6 semanas previas durante el período de enriquecimiento sin ajustes de la dosis;
    ? Diurético a cualquier dosis, a menos que esté contraindicado desde el punto de vista médico o sea intolerable desde el punto de vista clínico a criterio del investigador (es decir, hipotensión o hipopotasiemia);
    ? Variación en el peso < 3 kg y PNC sérico absoluto < 300 pg/ml (300 ng/l) en la semana de enriquecimiento 6 desde el comienzo del enriquecimiento;
    ? Los sujetos no deberán tener lesiones renales agudas al final del período de enriquecimiento, definidas por un aumento en la creatinina sérica > 0,5 mg/dl desde el inicio del ensayo y un aumento de > 20% en la semana de enriquecimiento 6 (visita E5) desde el inicio del ensayo.
    E.4Principal exclusion criteria
    1. Subject has a history of moderate or severe peripheral edema, pulmonary edema or facial edema unrelated to trauma or a history of myxedema in the prior 6 months to Screening.
    2. Subject has a history of pulmonary hypertension requiring oxygen therapy, and/or endothelin receptor antagonist or phosphodiesterase therapy or any lung diseases requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis).
    3. Subject has a documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure.
    4. Subject has known non-diabetic kidney disease (other than kidney stones).
    5. Subject has a history of symptomatic hypotension within the last 6 months.
    1. El sujeto tiene antecedentes de edema periférico moderado o grave, edema pulmonar o edema facial no relacionado con un traumatismo, o antecedentes de mixedema en los 6 meses previos a la selección.
    2. El sujeto tiene antecedentes de hipertensión pulmonar que requiere tratamiento con oxígeno, un antagonista del receptor de endotelina o fosfodiesterasa, o cualquier enfermedad pulmonar que requiera tratamiento con oxígeno (p.ej., enfermedad pulmonar obstructiva crónica, enfisema, fibrosis pulmonar).
    3. El sujeto tiene un diagnóstico documentado de insuficiencia cardíaca, ingreso hospitalario previo por insuficiencia cardíaca, o se considera que sus síntomas actuales o constelación de síntomas (disnea por esfuerzo, edema maleolar, ortopnea, disnea nocturna paroxística) son compatibles con una insuficiencia cardíaca que no fue explicada por otras causas, y para la cual hubo un cambio en la medicación u otro tratamiento para la insuficiencia cardíaca.
    4. El sujeto tiene una enfermedad renal no diabética conocida (que no sean cálculos renales).
    5. El sujeto tiene antecedentes de hipotensión sintomática en los últimos 6 meses.
    E.5 End points
    E.5.1Primary end point(s)
    Time to the first occurrence of a component of the composite renal endpoint: doubling of serum creatinine (confirmed by a 30-day serum creatinine) or the onset of ESRD (needing chronic dialysis or renal transplantation or renal death).
    Tiempo hasta la primera aparición de un componente del criterio de valoración renal combinado: duplicación del valor de creatinina sérica (confirmado por creatinina sérica de 30 días) o la aparición de enfermedad renal en fase terminal (que requiera diálisis crónica o trasplante renal, o cause la muerte renal).
    E.5.1.1Timepoint(s) of evaluation of this end point
    End points are monitored throughout the study
    Los criterios son monitorizados durante todo el estudio
    E.5.2Secondary end point(s)
    ? Change from baseline to Month 24 post-randomization visit on UACR.
    ? Time to a 30% eGFR reduction after 3 months post-randomization treatment.
    ? Time to cardio-renal composite endpoint: doubling of serum creatinine, ESRD, CV death, nonfatal myocardial infarction, nonfatal stroke.
    ? Time to the CV composite endpoint: CV death, nonfatal myocardial infarction and nonfatal stroke.
    ? Cambio en el UACR desde el inicio del ensayo hasta la visita posterior a la aleatorización del mes 24.
    ? Tiempo hasta una reducción del 30% en la TFGe después de 3 meses de tratamiento posterior a la aleatorización.
    ? Tiempo hasta el criterio de valoración cardio-renal combinado: duplicación del valor de creatinina sérica, ERT, muerte cardiovascular, infarto de miocardio no mortal, accidente cerebrovascular no mortal.
    ? Tiempo hasta el criterio de valoración cardiovascular combinado: muerte cardiovascular, infarto de miocardio no mortal y accidente cerebrovascular no mortal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End points are monitored throughout the study
    Los criterios son monitorizados durante todo el 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 No
    E.6.10Pharmacogenetic Yes
    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 concerned21
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA200
    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
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Greece
    Hong Kong
    Ireland
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Netherlands
    New Zealand
    Norway
    Portugal
    Puerto Rico
    Spain
    Sweden
    Israel
    Mexico
    Peru
    Poland
    Romania
    Russian Federation
    Singapore
    Slovakia
    South Africa
    Switzerland
    Taiwan
    Turkey
    Ukraine
    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
    LVLS
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 1500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4700
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state210
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1300
    F.4.2.2In the whole clinical trial 6200
    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)
    Subjects who have completed this study will be invited to participate in an open-label study with Atrasentan 0,75 mg
    Los pacientes que completen este estudio seran invitados a participar en un estudio de extensión abierto independiente con atrasentan
    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 Decision2013-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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