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    Summary
    EudraCT Number:2009-014868-19
    Sponsor's Protocol Code Number:AKTN06.01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-08-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-014868-19
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, factorial-design trial to assess the effect of aspirin & fish oil in the prevention of early thrombosis in arterio-venous fistulae in patients with Stage IV/ V chronic renal disease requiring haemodialysis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FAVOURED (Fish oil and Aspirin in Vascular access OUtcomes in REnal Disease)
    A.3.2Name or abbreviated title of the trial where available
    Favoured Study (Version 9.2 UK)
    A.4.1Sponsor's protocol code numberAKTN06.01
    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 SponsorAustralian Kidney Trials Network, University of Queensland
    B.1.3.4CountryAustralia
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name Omacor Omega-3 ethyl esters 90
    D.2.1.1.2Name of the Marketing Authorisation holderPronova BioPharma Norge AS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameOmacor
    D.3.4Pharmaceutical form Capsule, soft
    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 INNIcosapent ethyl ester
    D.3.9.1CAS number 86227-47-6
    D.3.9.3Other descriptive nameeicosapentaenoic acid (EPA) ethyl ester
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number460
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDoconexent ethyl ester
    D.3.9.1CAS number 81926-94-5
    D.3.9.3Other descriptive namedocosahexaenoic acid (DHA) ethyl ester
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number380
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Aspirin® protect 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAspirin protect 100mg
    D.3.4Pharmaceutical form 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 INNnot applicable
    D.3.9.1CAS number 50-78-2
    D.3.9.3Other descriptive nameacetylsalicylic acid
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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, soft
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Prevention of early thrombosis in arterio-venous fistulae in patients with Stage IV or V chronic kidney disease requiring haemodialysis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10060478
    E.1.2Term Thrombosis prophylaxis in haemodialysis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10059336
    E.1.2Term Haemodialysis fistula thrombosis
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    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 this trial is to determine whether the use of omega-3 fatty acids reduce the arterio-venous fistulae (AVF) failure rate for new AVF, compared to placebo within the first 12 months post AVF surgery.
    E.2.2Secondary objectives of the trial
    Secondary efficacy objectives:

    To study the effect of omega-3 fatty acids compared placebo on the following categories of objectives:

    1. Thrombosis (clotting)
    a. the rate of AVF Thrombosis within 12 months post AVF surgery
    b. the rate of primary patency at various time points after surgery (within 24 hours, at weeks 1, 6 and 12 and months 6 and 12)
    c. the rate of rescue interventions within 12 months post AVF surgery
    d. time to the first rescue intervention

    2. Permanent AVF abandonment
    a. the rate of permanent abandonment within 12 months post AVF surgery
    b. time to permanent abandonment of the study AVF

    3. Cannulation
    a. the rate of Cannulation Failure during the Cannulation Assessment Period
    b. time to the first successful cannulation

    4. Central Venous Catheter (CVC) requirement
    a. for haemodialysis on ≥1 occasion between 12 weeks and 12 months post AVF Surgery
    b. for haemodialysis on ≥1 occasion during Cannulation Assessment Period
    c. for haemodialysis
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    All details are contained within the main protocol.

    RBC fatty acid substudy
    Omega-3 fatty acids incorporated into the red blood cell membrane will be used as a compliance measure. In addition, there will be a cross sectional assessment looking at RBC omega-3s and patient characteristics.
    This substudy will be undertaken by only the Australian and New Zealand sites.

    Dietary and physical questionnaire
    Many CKD patients have poor diets and malnutrition. This sub-study explores the status and the significance of dietary intake (including fish) and lifestyle factors in relation to patient outcomes. In particular, the questionnaire results will enable the interaction between these lifestyle and dietary factors and response to omega-3 fatty acids supplementation to be explored.
    This substudy will be undertaken by all participating sites.

    Pre-surgical Doppler studies
    This sub-study explores whether pre-operative vascular characteristics determined by duplex ultrasound will predict vascular access outcomes either independently or in particular, the response to aspirin, omega-3 fatty acids and the combination.
    This substudy will be undertaken by interested sites in any of participating countries with the requisite vein mapping faculties.

    Platelet and Coagulation Function
    This substudy aims to study the effects of aspirin and omega-3 fatty acids alone and the combination on platelet function, coagulation and platelet activation as well as quantification of compliance with aspirin (prostaglandin metabolites).
    This substudy will be undertaken by only the Australian and New Zealand sites.

    Micro-particle Analysis
    This sub study aims to study the effects of aspirin and omega-3 fatty acids alone and in combination on the formation of pro coagulant micro particles.
    This substudy will be undertaken by interested UK sites only
    E.3Principal inclusion criteria
    Patients must meet the following inclusion criteria:
    1. Stage 4 or 5 Chronic Kidney Disease
    2. Currently on haemodialysis or haemodialysis is planned to start within 12 months (including patients currently on peritoneal dialysis).
    3. Planned AVF will be the primary haemodialysis access mechanism.
    4. Surgery to create an arterio-venous fistula in the upper or lower arm is planned.
    5. Aged over 19 years
    6. Treating team agreeable to patient’s involvement in the trial
    7. Informed consent
    E.4Principal exclusion criteria
    Patients must not meet any of the following exclusion criteria:
    1. Revision of existing AVF rather than de novo AVF
    2. Medical indication for anti-platelet or thrombolytic agents*
    3. Known intolerance of agents including hypersensitivity to aspirin, allergy to any other NSAIDs or fish or hypersensitivity to soya.
    4. Current use of aspirin within two weeks of commencing trial, or of omega-3 fatty acids within 4 weeks of commencing trial*
    5. Pregnancy, lactation or intention to fall pregnant during the time course of the study
    6. Known bleeding disorder or established diagnosis of active or suspected bleeding
    7. History of GI ulcers or bleeding within the last 3 months
    8. Platelet count less than 100 x 109 /L
    9. Known active peptic ulcer disease
    10. Severe hepatic insufficiency
    11. Already receiving anti-coagulation therapy such as warfarin
    12. Receiving regular non-steroidal anti-inflammatory (NSAIDS) agents for another indication such as arthritis
    13. Syndrome of asthma, rhinitis and nasal polyps if uncontrolled on usual therapy
    14. Plan to have other (non-access) surgery within 2 weeks of trial medication period where, in the opinion of the investigator, aspirin or omega-3 fatty acids would be contraindicated for the planned procedure.
    15. Potential non-compliance with treatment regimen in the view of the treating clinicians
    16. Involved in another clinical trial where the intervention being trialled is likely to confound the outcome of this trial
    17. Previously randomised to this trial.
    *Note: Patients who fail to meet the exclusion criteria 2 (Medical indication for anti-platelet or thrombolytic agents) and exclusion criteria 4 (Current use of aspirin within two weeks of commencing trial), and who are otherwise suitable will be enrolled into the expanded protocol.

    E.5 End points
    E.5.1Primary end point(s)
    AVF Access Failure is a composite of
    • Thrombosis: This is defined as the absence of a thrill or bruit clinically and/or the requirement of Rescue Intervention to restore patency for thrombosis or occlusion for the study AVF between AVF Surgery and Month 12 Visit. Please refer to section 4.6.5 for further information about Rescue Intervention events.
    • AVF Abandonment: This is defined as the permanent abandonment of study AVF between AVF Surgery and Month 12 Visit. Please refer to section 4.6.4 for further information about AVF abandonment.
    • Cannulation Failure: This is defined as the failure to successfully cannulate the study AVF with 2 needles (or with 1 needle if using single needle dialysis method) during 8 or more 12 HD sessions. Please refer to Section 4.6.3 for further information about Assessment Periods.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As defined above
    E.5.2Secondary end point(s)
    4.5.2 Secondary
    Thrombosis
    • Thrombosis: This is defined as the absence of a thrill or bruit clinically and/or the requirement of Rescue Intervention to restore patency for thrombosis or occlusion for the study AVF between AVF Surgery and Month 12 Visit. Please refer to section 4.6.5 for further information about Rescue Intervention events.
    • Primary patency at various time points: This is defined as the presence of an audible bruit over the site of the arterio-venous anastomosis at time points of within 24 hours post surgery (Recovery visit), and Visits Weeks 1, 6 and 12 and Months 6 and 12.
    • Number and type of Interventions: This is defined as the number and type of interventions (both rescue and non-rescue) the study AVF requires between AVF Surgery and Month 12 Visit. Please refer to section 4.6.5 for further information about Rescue Intervention events.
    • Time to first Rescue Intervention: This is defined as the time from AVF creation to first occasion of rescue intervention up to Month 12 Visit. Please refer to section 4.6.5 for details of the Rescue Intervention events.

    Permanent AVF abandonment
    • AVF Abandonment: This is defined as the permanent abandonment of study AVF between AVF Surgery and Month 12 Visit. Please refer to section 4.6.4 for further information about AVF abandonment.
    • Time to AVF Abandonment: This is defined as the time from AVF Surgery to permanent abandonment of study AVF up to Month 12 Visit. Please refer to section 4.6.4 for further information about AVF abandonment

    Cannulation
    • Cannulation Failure: This is defined as the failure to successfully cannulate the study AVF with 2 needles (or with 1 needle if using single needle dialysis method) during 8 or more 12 HD sessions. Please refer Section 4.6.3 for the Cannulation Assessment Periods.
    • Time to the first Successful Cannulation: This is defined as the time taken from the AVF Surgery until the first successful attempt at access cannulation up until Month 12 Visit.

    Central Venous Catheter (CVC) requirement
    • CVC Requirement between Visits Week 12 and Month 12: This is defined as the use of a CVC on any occasion to provide vascular access for HD between Week 12 and Month 12 Visits.
    • CVC Requirement during CAP: This is defined as the use of a CVC on any occasion to provide vascular access for HD during Cannulation Assessment Period. Please refer to section 4.6.3 for further information about assessment periods.
    • CVC Requirement after CAP: This is defined as the use of a CVC on any occasion to provide vascular access for HD after Cannulation Assessment Period to Month 12 Visit. Please refer to section 4.6.3 for further information about Assessment Periods.
    • Days of CVC: This is defined as the number of days a CVC is present in situ between Week 12 and Month 12 Visits.
    E.5.2.1Timepoint(s) of evaluation of this end point
    AS defined above
    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 No
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned8
    E.8.5The trial involves multiple Member States No
    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
    Malaysia
    New Zealand
    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 of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 954
    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)
    The duration of treatment with the study medication is relatively short term (12 weeks) as the aim of the study is the prevention of early thrombosis in the AVF rather than ongoing treatment. It is felt that the 12 months minimum follow up period is sufficient.

    After the study period the participants will revert to the standard care for their renal unit as overseen by their nephrologist.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Trent CLRN
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-14
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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