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    Summary
    EudraCT Number:2016-002834-59
    Sponsor's Protocol Code Number:SNFCT2015-05
    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:2016-09-26
    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 number2016-002834-59
    A.3Full title of the trial
    A double-blind, randomised, placebo-controlled study to assess the effect of SNF472 on progression of cardiovascular calcification on top of standard of care in end-stage-renal-disease (ESRD) patients on haemodialysis (HD)
    Estudio doble ciego, aleatorizado, controlado con placebo para evaluar el efecto de SNF472 en la progresión de la calcificación cardiovascular además del tratamiento de referencia en pacientes con nefropatía terminal (NT) sometidos a hemodiálisis (HD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess the effect of SNF472 on progression of build up of calcium in coronary blood vessels in patients with kidney disease.
    Ensayo clínico para evaluar el efecto de SNF472 sobre la progresión de la acumulación de calcio en los vasos sanguíneos coronarios en pacientes con enfermedad renal.
    A.4.1Sponsor's protocol code numberSNFCT2015-05
    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 SponsorLaboratoris Sanifit
    B.1.3.4CountrySpain
    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 supportLaboratoris Sanifit
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAccovion, S.L.
    B.5.2Functional name of contact pointProject Manager/CRA
    B.5.3 Address:
    B.5.3.1Street AddressParque Empresarial "La Finca" Paseo Club Deportivo, 1 Edificio 17 planta baja
    B.5.3.2Town/ cityPozuelo de Alarcón, Madrid
    B.5.3.3Post code28223
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900839188
    B.5.6E-mailmmarlasca@clinipace.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 nameSNF472
    D.3.2Product code SNF472
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMyo-inositol hexaphosphate (IP6, phytate)
    D.3.9.1CAS number 34367-89-0
    D.3.9.2Current sponsor codeSNF472
    D.3.9.3Other descriptive nameSNF472
    D.3.9.4EV Substance CodeSUB166954
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cardiovascular calcification in blood vessels in end-stage-renal-disease (ESRD) patients on haemodialysis (HD).
    Calcificación cardiovascular en los vasos sanguíneos de pacientes con nefropatía renal (NT) sometidos a hemodiálisis (HD).
    E.1.1.1Medical condition in easily understood language
    Build up of calcium in coronary blood vessels in patients with kidney disease.
    La acumulación de calcio en los vasos sanguíneos coronarios en pacientes con enfermedad renal.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10014646
    E.1.2Term End stage renal disease (ESRD)
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10051753
    E.1.2Term Vascular calcification
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10018875
    E.1.2Term Haemodialysis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 is to assess the effect of 2 dose levels of SNF472 (300 mg and 600 mg) compared to placebo on the progression of absolute change in coronary artery calcium volume score over a 12 month (52 weeks) period in ESRD patients on HD.
    El objetivo principal consiste en evaluar el efecto de 2 niveles de dosis de SNF472 (300 mg y 600 mg) en comparación con placebo en la progresión del cambio absoluto en la puntuación del volumen de calcio en las arterias coronarias a lo largo de un periodo de 12 meses (52 semanas) en pacientes con NT sometidos a HD.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:
    •assess change in percent change from baseline (Week 1, Day 1) in coronary artery calcium volume score
    •assess changes in absolute and percentage change from baseline (Week 1, Day 1) in coronary artery calcium (CAC)/Agatston score
    •assess the number of patients with <15% progression in CAC/Agatston score
    •assess the change from baseline in thoracic aorta calcification score
    •assess the change from baseline in aortic valve calcification score
    •assess composite safety endpoint of death, myocardial infarction (MI), stroke, and heart failure
    •assess biomarkers as early signals for treatment efficacy/response
    •assess changes in bone mineral density (BMD)
    •describe the long-term safety profile of SNF472 in this target population
    •evaluar el cambio en el porcentaje respecto a la situación basal (semana 1, día 1) en la puntuación del volumen de calcio en las arterias coronarias
    •evaluar los cambios absolutos y en el porcentaje respecto a la situación basal (semana 1, día 1) en la puntuación de calcio en las arterias coronarias (CAC)/Agatston
    •evaluar el número de pacientes con < 15 % de progresión en la puntuación de CAC/Agatston
    •evaluar el cambio respecto a la situación basal en la puntuación de calcificación de la aorta torácica
    •evaluar el cambio respecto a la situación basal en la puntuación de calcificación de la válvula aórtica
    •evaluar el criterio de valoración de seguridad compuesto de muerte, infarto de miocardio (IM), ictus e insuficiencia cardíaca
    •evaluar los biomarcadores como señales precoces para la eficacia del tratamiento y la respuesta al tratamiento
    •evaluar los cambios en la densidad mineral ósea (DMO)
    describir el perfil de seguridad a largo plazo de SNF472 en la población objetivo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study title, date and version is same as the main study title. Plasma Pharmacokinetics and Biomarker testing will be performed in order to measure the amount of study drug in the patient and to get information about the status or progression of the disease
    El título, fecha y versión del subestudio es igual que el título del estudio principal. Se realizarán pruebas de farmacocinética de plasma de biomarcadores con el fin de medir la cantidad de fármaco de estudio en el paciente y para obtener información sobre el estado o la progresión de la enfermedad.
    E.3Principal inclusion criteria
    1. female or male patients, 18 to 80 years (inclusive) of age at randomisation
    2. CAC score of 100 to 2000 AU inclusive within a 3-week period prior to randomisation, as measured by a multi-detector CT scanner
    3. patients who are EITHER ≥ 55 years OR have a history of diabetes mellitus at randomisation
    4. patients on HD for ≥ 6 months prior to randomisation
    5. willing and able to understand and sign the informed consent
    1. mujeres o varones de 18 a 80 años (ambos inclusive) en el momento de la aleatorización
    2. puntuación de CAC de 100 a 2000 UA (unidades de Agatston) (ambos inclusive) en un periodo de 3 semanas antes de la aleatorización medida por un tomógrafo multidetector
    3. pacientes de ≥ 55 años o con antecedentes de diabetes mellitus en la aleatorización
    4. pacientes sometidos a HD durante ≥ 6 meses antes de la aleatorización
    5. estar dispuesto y ser capaz de entender y firmar el consentimiento informado
    E.4Principal exclusion criteria
    1. scheduled date for kidney transplant from a known living donor
    2. weight above 300 lbs (136 kg)
    3. hospitalisation in the previous 3 months prior to randomisation for unstable angina, MI, stroke, transient ischaemic attack, amputation or peripheral or coronary bypass surgery
    4. history of unstable heart failure in the previous 3 months, defined as an unplanned presentation to a hospital or dialysis treatment facility with signs/symptoms of acute pulmonary edema and requiring ultrafiltration therapy
    5. history of cancer that has been in remission for < 5 years prior to randomisation. A history of basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin is allowed
    6. pregnant or trying to become pregnant, currently breast-feeding, or of child-bearing potential (including peri-menopausal women who have had a menstrual period within one year) and not willing to practice birth control using a double barrier method (criteria apply to women only) at least 30 days post last dose of study medication
    7. hypocalcaemia defined as a serum calcium below 8.0 mg/dL (or 2.0 mmol/L) for the serum calcium most proximal to screening per patient’s medical records
    8. extreme elevation in serum phosphorous, defined as a phosphorous above 10 mg/dL (or 3.23 mmol/L) within the last 2 months proximal to screening per patient’s medical records
    9. uncontrolled hypertension defined as any 2 or more consecutive post-dialysis DBP > 100 mmHg within the last 2 months proximal to screening
    10. expected survival < 2 years in the Investigator’s medical opinion
    11. known active drug or alcohol abuse within 1 year of randomisation
    12. use of other investigational drugs within 30 days of randomisation
    13. non-compliance with dialysis treatment which, in the opinion of the Investigator, evidenced by either repeated missed dialysis treatments or significant non-compliance with the patient’s medication regimen
    14. Inability to comply with all required study procedures and schedule, inability to speak and read in the protocol-derived language of that patient's clinical site, or unwillingness or inability to give written informed consent
    1. fecha programada para un trasplante de riñón de un donante vivo conocido
    2. peso superior a 136 kg
    3. hospitalización en los 3 meses previos a la aleatorización por angina de pecho inestable, IM, ictus, ataque isquémico transitorio, amputación o cirugía de derivación coronaria o periférica
    4. antecedentes de insuficiencia cardíaca inestable en los 3 meses previos, definidos como una presentación no planificada a un hospital o centro de tratamiento con diálisis con signos/síntomas de edema pulmonar agudo que requieran tratamiento de ultrafiltración
    5. antecedentes de cáncer en remisión durante < 5 años antes de la aleatorización. Los antecedentes de carcinoma de células basales o carcinoma de piel de células escamosas de estadio 1 están permitidos
    6. mujeres embarazadas o que estén intentado quedarse embarazadas, en periodo de lactancia o en edad fértil (incluyendo mujeres perimenopáusicas que han tenido un periodo menstrual en un año) y que no están dispuestas a utilizar contracepción mediante un método de doble barrera (los criterios se aplican solo a mujeres) al menos 30 días después de la última dosis de la medicación del estudio
    7. hipocalcemia, definida como calcio sérico por debajo de 8,0 mg/dl (o 2,0 mmol/l) en el calcio sérico más próximo a la selección según la historia clínica del paciente
    8. elevación extrema del fósforo sérico, definida como fósforo sérico por encima de 10 mg/dl (o 3,23 mmol/l) en los dos últimos meses próximos a la selección según la historia clínica del paciente
    9. hipertensión no controlada definida como 2 o más determinaciones consecutivas de presión arterial diastólica (PAD) tras la diálisis > 100 mmHg en los 2 últimos meses próximos a la selección
    10. supervivencia esperada < 2 años según la opinión médica del investigador
    11. alcoholismo o toxicomanía actuales conocidos en un periodo de 1 año anterior a la aleatorización
    12. uso de otros fármacos en investigación en los 30 días anteriores a la aleatorización
    13. no cumplimiento del tratamiento de diálisis que, a opinión del investigador, se evidencia por saltarse varios tratamientos de diálisis o por un no cumplimiento destacable de la pauta de tratamiento del paciente
    14. incapacidad de cumplir todos los procedimientos y el calendario del estudio requeridos, incapacidad de hablar y leer en el idioma del protocolo del centro clínico del paciente, o reticencia o incapacidad de proporcionar el consentimiento informado por escrito
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the absolute change in coronary artery calcium volume scores measured by CT scan.
    El criterio de valoración principal es el cambio absoluto en la puntuación del volumen de calcio en las arterias coronarias entre la situación basal (semana 1, día 1) y la semana 52 medido por tomografía computarizada (TC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (Week 1, Day 1) and Week 52
    Situación basal (Semana 1, Día 1) y Semana 52.
    E.5.2Secondary end point(s)
    • percentage change from baseline in calcium volume score at Week 52
    • absolute change from baseline in CAC/Agatston score at Week 52
    • percentage change from baseline in CAC/Agatston score at Week 52
    • number of patients with <15% progression in CAC/Agatston score at Week 52
    • change from baseline in thoracic aorta calcification score at Week 52
    • change from baseline in aortic valve calcification score at Week 52
    • incidence of composite safety endpoint that include CV death (not all-cause), MI, stroke, and heart failure
    • mortality rate (all-cause and CV)
    • change from baseline in levels of selected biomarkers

    The endpoints above will be analysed as efficacy as well as safety endpoints. The following secondary safety endpoints will be analysed:
    • changes in BMD levels between baseline and Week 52
    • safety of SNF472 in terms of adverse event (AE) and SAE incidences
    • cambio en el porcentaje respecto a la situación basal en la puntuación del volumen de calcio en la semana 52
    • cambio absoluto respecto a la situación basal en la puntuación de CAC/Agatston en la semana 52
    • cambio en el porcentaje respecto a la situación basal en la puntuación de CAC/Agatston en la semana 52
    • número de pacientes con < 15 % de progresión en CAC/Agatston en la semana 52
    • cambio respecto a la situación basal en la puntuación de calcificación de la aorta torácica en la semana 52
    • cambio respecto a la situación basal en la puntuación de calcificación de la válvula aórtica en la semana 52
    • incidencia del criterio de valoración de seguridad compuesto que incluye la muerte cardiovascular (CV) (no por todas las causas), IM, ictus e insuficiencia cardíaca
    • tasa de mortalidad (todas las causas y CV)
    • cambio respecto a la situación basal en la concentración de determinados biomarcadores

    Los criterios de valoración anteriores se analizarán como criterios de valoración de eficacia así como de seguridad
    • cambios en la DMO entre la situación basal y la semana 52
    • seguridad de SNF472 en lo referente a la incidencia de acontecimientos adversos (AA) y acontecimientos adversos graves (AAG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52
    Semana 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Ireland
    Italy
    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
    Last Visit Last Subject (LVLS)
    Última visita ültimo sujeto (UVUS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months30
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 450
    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 Decision2016-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-14
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