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    Summary
    EudraCT Number:2016-002834-59
    Sponsor's Protocol Code Number:SNFCT2015-05
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-19
    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 ConcernedUK - MHRA
    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)
    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.
    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 SponsorSanifit Therapeutics S.A.
    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 supportSanifit Therapeutics S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanifit Therapeutics S.A.
    B.5.2Functional name of contact pointAna-Zeralda Canals
    B.5.3 Address:
    B.5.3.1Street AddressParc BIT, Edificio Europa, 2nd floor
    B.5.3.2Town/ cityPalma de Mallorca
    B.5.3.3Post code07121
    B.5.3.4CountrySpain
    B.5.4Telephone number+34971439925
    B.5.6E-mailana-zeralda.canals@sanifit.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.3.9.1CAS 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 typerange
    D.3.10.3Concentration number to 30mg/mL
    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).
    E.1.1.1Medical condition in easily understood language
    Build up of calcium in coronary blood vessels in patients with kidney disease.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    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 20.0
    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 20.0
    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 coronary artery calcium volume score over a 12 month (52 weeks) period in ESRD patients on HD.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:
    •assess 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 the occurrence of the composite safety endpoint: death, from cardiovascular causes, myocardial infarction (MI), stroke, or heart failure
    •assess change in biomarkers as signals for treatment efficacy/response
    •assess changes in bone mineral density (BMD)
    •describe the long-term safety profile of SNF472 in this target population

    The exploratory objective is to assess changes from baseline in pulse pressure, systolic blood
    pressure (SBP), and diastolic blood pressure (DBP).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A) Pharmacokinetic & Biomarker Sub-study: Same title, date and version as the main study. Plasma Pharmacokinetic and Biomarker samples will be assessed to measure concentration of study drug/metabolites over time and to obtain information about the
    B) SNFCT2015-05 ECHO Sub-Study:
    Title: Sub-Study to Assess the Effects of SNF472 on Arterial Stiffness and Cardiovascular Function in ESRD Patients on Hemodialysis Number of Patients and Study Centre(s): It is estimated that up to 50% of the sites participating in the main study may opt into participating in the Sub-Study in order to enroll up to 200 subjects.
    Objectives:
    The primary objective of this Sub-Study is to assess the effect of 2 dose levels of SNF472 (300 mg and 600 mg) compared to placebo on the progression of arterial stiffness as measured by an absolute change in pulse wave velocity (PWV) over a 52-week period in ESRD patients on HD.
    The secondary objectives of this Sub-Study are to assess:
    • Change from Sub-Study Entry in left ventricular mass index (LVMI)
    • Change from Sub-Study Entry in left ventricular (LV) function parameters
    The exploratory objectives of this Sub-Study are to assess:
    • Change from Sub-Study Entry in left atrial (LA) function and change in parameters over time
    • Change from Sub-Study Entry in aortic valve gradient
    Methodology: Patients enrolled in the main study will be eligible to participate in this Sub-Study and will be requested to undergo additional assessment as outlined in the Sub-Study Schedule of Assessments.
    Endpoints:
    The primary endpoint is the absolute change in aortic PWV (m/s) from Sub-Study Entry to Week 52 by 2-dimensional (2D) echocardiography.
    The secondary endpoints will be assessed by 2-D echocardiography and are:
    • Absolute change in LVMI from Sub-Study Entry to Week 52.
    • Absolute change in LV function from Sub-Study Entry to Week 52:
    o Absolute change in the ratio of mitral inflow early diastolic to mitral annular velocity (E/e’ ratio)
    o Absolute change in mitral annular early diastolic tissue velocity (e’) measured with tissue Doppler average of septal and lateral values)
    o Absolute change in LV global longitudinal systolic strain (%) measured by speckle tracking echocardiography
    The exploratory endpoints are:
    • Absolute change in additional measures of LA volume (mL) and LA ejection fraction from Sub-Study Entry to Week 52:
    • Absolute change in PWV, LVMI and other parameters of LV and LA function over time (Weeks 28 and 52).
    • Absolute change in aortic valve gradient from Sub-Study Entry to Week 28 and Week 52 in all subjects and in the subgroup of subjects with evidence of aortic stenosis at Sub-Study Entry
    Criteria for Inclusion:
    12. Participant in the main study
    13. Willing and able to understand and sign the additional Sub-Study informed consent
    Criteria for Exclusion:
    14. Presence of current atrial fibrillation, atrial flutter with variable atrioventricular conduction, or very frequent premature beats (premature ventricular contractions [PVCs])
    15. A diagnosis of primary hypertrophic obstructive cardiomyopathy, or cardiac infiltrative disease (such as cardiac amyloidosis).
    16. Severe cardiac valve disease
    Statistical Methods: The primary sub-study endpoint will be summarized using descriptive statistics and analyzed using ANCOVA model (The details of the analysis is been highlighted in the Sub study protocol synopsis)

    The secondary and exploratory endpoints will be summarized using descriptive statistics by treatment arm and analyzed using methods similar to the primary Sub-Study endpoint.
    E.3Principal inclusion criteria
    1. female or male patients, 18 to 80 years (inclusive) of age at randomisation
    2. CAC score of 100 to 3500 AU inclusive within a 4-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
    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
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in coronary artery calcium volume scores measured by CT scan.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (Week 1, Day 1) and Week 52
    E.5.2Secondary end point(s)
    • 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 death from cardiovascular ,causes, MI, stroke, or heart failure
    • mortality rate (all-cause and CV)
    • change from baseline in levels of selected biomarkers including C-reactive protein (CRP)


    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 incidences of adverse event (AE) and SAE and clinically relevant changes from baseline in laboratory and
    ECG parameters

    The exploratory endpoints are changes from baseline in pulse pressure, SBP, and DBP at Week 28 and Week 52 in all patients and in the subgroup of patients with hypertension at baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    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)
    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 months37
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months37
    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: 162
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 108
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 270
    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
    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 Decision2016-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-14
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