Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43870   clinical trials with a EudraCT protocol, of which   7289   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-003819-22
    Sponsor's Protocol Code Number:ID-080A305
    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:2019-11-06
    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 number2018-003819-22
    A.3Full title of the trial
    Multi-center, blinded, randomized study with aprocitentan in subjects with uncontrolled blood pressure and chronic kidney disease stage 3 or 4.
    Estudio multicéntrico, ciegoy aleatorizado con aprocitentán en sujetos con presión arterial no controlada y enfermedad renal crónica estadio 3 o 4
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to find out if aprocitentan is efficacious and safe to treat patients with uncontrolled blood pressure and chronic kidney disease
    Un estudio de investigación para averiguar si aprocitentan es eficaz y seguro en el tratamiento de pacientes con tensión arterial no controlada y enfermedad crónica del riñón
    A.3.2Name or abbreviated title of the trial where available
    INSPIRE-CKD
    A.4.1Sponsor's protocol code numberID-080A305
    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 SponsorIdorsia Pharmaceuticals Ltd
    B.1.3.4CountrySwitzerland
    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 supportIdorsia Pharmaceuticals Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIdorsia Pharmaceuticals Ltd
    B.5.2Functional name of contact pointClinical Trial Disclosure Desk
    B.5.3 Address:
    B.5.3.1Street AddressHegenheimermattweg 91
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34910 05 28 83
    B.5.6E-mailclinical-trials-disclosure@idorsia.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 nameAprocitentan
    D.3.2Product code ACT-132577
    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 INNAprocitentan
    D.3.9.2Current sponsor codeACT-132577
    D.3.9.3Other descriptive nameACT-132577
    D.3.9.4EV Substance CodeSUB191068
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Hypertension
    Hipertensión
    E.1.1.1Medical condition in easily understood language
    High blood pressure
    Presión sanguínea elevada
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    The primary objective of the study is to demonstrate the blood pressure (BP) lowering effect of aprocitentan when added to background antihypertensive therapy in subjects with uncontrolled BP and chronic kidney disease (CKD) stage 3 or 4 after 4 weeks of double-blind (DB) treatment.
    El objetivo principal del estudio es demostrar el efecto de reducción de la presión arterial (PA) de aprocitentán cuando se añade a un tratamiento antihipertensivo de base en sujetos con PA no controlada y enfermedad renal crónica (ERC) en estadio3 o 4 después de 4 semanas de tratamiento a doble ciego (DC).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate:
    - the effect of aprocitentan on urine albumin-to-creatinine ratio (UACR) after 4 weeks of DB treatment in a subset of study population; i.e., in subjects with a UACR greater than 30 mg/g at baseline;
    - the safety and tolerability of aprocitentan in this study population during 12 weeks of the randomized treatment period.
    Los objetivos secundarios son evaluar:

    - El efecto de aprocitentán en el cociente de microalbúmina y creatinina (UACR) después de 4 semanas de tratamiento a DC en un subconjunto de población del estudio; es decir, en sujetos con un UACR > 30 mg/g en el momento basal;
    - La seguridad y tolerabilidad de aprocitentán en esta población del estudio durante las 12 semanas del periodo de tratamiento aleatorizado.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Screening Visit:
    - Signed and dated informed consent prior to any study-mandated procedure,
    - Adult male and female subjects,
    - Prior treatment with at least 2 anti-hypertensive medications, at optimal or best tolerated dose, of different pharmacological classes, including a diuretic,
    - Subjects with uncontrolled blood pressure (mean sitting systolic blood pressure of 140 mmHg or greater) and chronic kidney disease stage 3 or 4 (estimated Glomerular Filtration Rate, eGFR, of at least 15 and below 60 mL/min/1.73m2 using the Chronic Kidney Disease-Epidemiology (CKD-EPI)
    equation.),
    - Women of childbearing potential (WOCBP) are eligible only if the following applies:
    --Negative pregnancy test at the screening visit and at baseline (i.e., end of Run-in period).
    -- Agree to undertake pregnancy tests during the study and up to 30 days after randomized study treatment discontinuation.
    -- Agree to use highly-effective methods of contraception as described up to at least 30 days after randomized study treatment discontinuation.

    Run-in period criteria:
    - Mean trough sitting systolic blood pressure of 140 mmHg or higher measured by automated office blood pressure measurement (AOBPM).

    Randomization (Baseline) criteria (end of the 2 week run-in period):
    - Mean trough sitting systolic blood pressure of 140 mmHg or higher measured by AOBPM,
    - Stable background anti-hypertensive therapy (including a diuretic) since the start of the run-in period,
    - Estimated glomerular filtration rate (eGFR) equal or above 15 to less than 60 mL/min/1.73 m2,
    - Subject is at least 80% compliant with study treatment (tablet count) during the run-in period.
    Visita de selección:
    - Consentimiento informado firmado y fechado antes de cualquier procedimiento del estudio,
    - sujetos masculinos y femeninos adultos,
    - Tratamiento previo con al menos 2 medicamentos antihipertensivos, a la dosis óptima o mejor tolerada, de diferentes clases farmacológicas, incluido un diurético,
    - Sujetos con tensión arterial no controlada (tensión arterial sistólica media en sedestación de 140 mmHg o más) y enfermedad renal crónica en estadio 3 o 4 (tasa de filtración glomerular estimada, eGFR, de al menos 15 y menos de 60 ml / min / 1.73m2 usando la ecuación del el Chronic Enfermedad renal-Epidemiología (CKD-EPI)),
    - Las mujeres en edad fértil (MEEF) son elegibles solo si se aplica lo siguiente:
    -- Prueba de embarazo negativa en la visita de selección y en basal (es decir, al final del período pre-basal).
    -- Acepte realizar pruebas de embarazo durante el estudio y hasta 30 días después de la interrupción del tratamiento aleatorizado del estudio.
    -- Acepte utilizar métodos anticonceptivos altamente efectivos como se describe hasta al menos 30 días después de la interrupción del tratamiento aleatorizado del estudio.

    Criterios del período pre-basal:
    - Tensión arterial sistólica media en sedestación de 140 mmHg o más, medida por la medición de tensión arterial automatizada (MPAC).

    Criterios de aleatorización (basal) (final del período de preinclusión de 2 semanas):
    - Tensión sanguínea sistólica media durante la sesión de 140 mmHg o superior medida por MPAC,
    - Tratamiento antihipertensivo de fondo estable (incluido un diurético) desde el inicio del período de pre-basal,
    - Tasa de filtración glomerular estimada (eGFR) igual o superior a 15 a menos de 60 ml / min / 1,73 m2,
    - El sujeto cumple al menos un 80% con el tratamiento del estudio (recuento de comprimidos) durante el período pre-basal.
    E.4Principal exclusion criteria
    - Mean sitting systolic blood pressure above 170 mmHg measured by automated office blood pressure measurement (AOBPM),
    - Mean sitting diastolic blood pressure above 105 mmHg measured by AOBPM,
    - Change in renal function requiring hospitalization,
    - Documented eGFR decline of more than 20% in the 3 months prior to the screening visit,
    - Dialysis in the 3 months before the screening visit,
    - Planned dialysis or kidney transplant during the course of this study,
    - Nephrotic syndrome defined as urine albumin-to-creatinine ratio above 3000 mg/g,
    - Known and documented chronic heart failure.
    - Tensión arterial sistólica media en sedestación por encima de 170 mmHg medida mediante medición de presión arterial automatizada (MPAC),
    - Tensión arterial diastólica media en sedestación por encima de 105 mmHg medida por MPAC,
    - Cambio en la función renal que requiere hospitalización,
    - disminución documentada de eGFR de más del 20% en los 3 meses anteriores a la visita de selección,
    - Diálisis en los 3 meses anteriores a la visita de selección,
    - Diálisis planificada o trasplante de riñón durante el curso de este estudio,
    - Síndrome nefrótico definido como una proporción de albúmina-creatinina en orina superior a 3000 mg / g,
    - Insuficiencia cardíaca crónica conocida y documentada.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Week 4 of double-blind (DB) treatment in mean trough sitting systolic blood pressure measured by automated office
    blood pressure measurement.
    cambio en el promedio del valor mínimo de la PASer, según MPAC automatizada, desde el momento basal hasta la semana 4 del tratamiento a DC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 Weeks (starting at the baseline visit, i.e. last assessment before start of the double-blind treatment to the end of the double-blind treatment part).
    4 semanas (empezando en la visita basal, es decir, ultimo procedimiento antes de empezar el tratamiento doble ciego hasta la finalización de la parte del tratamiento doble ciego)
    E.5.2Secondary end point(s)
    - Change from baseline to Week 4 of double-blind (DB) treatment in mean trough sitting diastolic blood pressure measured by automated
    office blood pressure measurement.
    -Ratio to baseline of urine albumin-to-creatinine ratio (UACR) at Week 4 of the DB treatment (evaluated in subjects with a UACR above 30 mg/g at baseline).
    - Cambio en el promedio del valor mínimo de la PADer, según MPAC automatizada, desde el momento basal hasta la semana 4 del tratamiento a DC.
    - Proporción con respecto al momento basal* de UACR en la semana 4 del tratamiento a DC (evaluado en sujetos con un UACR > 30 mg/g en el momento basal).
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 Weeks (starting at the baseline visit, i.e. last assessment before start of the double-blind treatment to the end of the double-blind part).
    4 semanas (empezando en la visita basal, es decir, ultimo procedimiento antes de empezar el tratamiento doble ciego hasta la finalización de la parte del tratamiento doble ciego)
    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 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 Yes
    E.8.1.7.1Other trial design description
    Pre-basal ciego simple, aleatorización doble ciego controlada con placebo, fase activo ciego simple
    Single blind placebo run-in, randomized placebo-controlled double-blind, single-blind active
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Belgium
    Canada
    Czech Republic
    France
    Hungary
    Korea, Republic of
    Latvia
    Lithuania
    Russian Federation
    Spain
    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
    End of trial is defined as last subject last visit (LSLV).
    Última visita del último 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 months7
    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 months7
    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: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 95
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 200
    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 subject's study completion or premature withdrawal from the study, whichever applies, the investigator / delegate will explain to subjects what approved treatment(s) / medical care is necessary and available according to local regulations.
    Tras la finalización del estudio (normal o prematura) el investigador o responsable explicará a los pacientes qué tratamientos o cuidados médicos son necesarios y están disponibles según aspectos locales
    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 Decision2019-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-12-18
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 01 11:11:52 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA