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    Summary
    EudraCT Number:2012-002448-25
    Sponsor's Protocol Code Number:MA3RSTrial
    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:2012-08-28
    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 number2012-002448-25
    A.3Full title of the trial
    Magnetic Resonance Imaging Using Ultrasmall Superparamagnetic Particles of Iron Oxide in Patients Under Surveillance for Abdominal Aortic Aneurysms to Predict Rupture or Surgical Repair: the MA3RS Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The use of magnetic resonance imaging and a novel contrast agent to predict rupture or need for surgical repair in patients under surveillance with abdominal aortic aneurysms.
    A.3.2Name or abbreviated title of the trial where available
    MAR3S Trial
    A.4.1Sponsor's protocol code numberMA3RSTrial
    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 SponsorUniversity of Edinburgh
    B.1.3.4CountryUnited Kingdom
    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
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian Health Board
    B.1.3.4CountryUnited Kingdom
    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 supportEfficacy and Mechanism Evaluation Programme (MRC/NIHR)
    B.4.2CountryUnited Kingdom
    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 Rienso
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Global Research and Development Centre (Europe) Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFerumoxytol
    D.3.4Pharmaceutical form Solution for injection
    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 INNiron
    D.3.9.3Other descriptive nameferumoxytol
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number510mg to 17ml
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Abdominal Aortic Aneurysm
    E.1.1.1Medical condition in easily understood language
    Swelling of the largest blood vessel in the body
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    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
    An abdominal aortic aneurysm is a swelling of the main blood vessel that supplies the organs in the abdomen and the legs. It most commonly occurs just below the kidneys (approximately at the level of the belly button). It is not yet clear why some people develop aneurysms but they are more common in smokers and in men. Abdominal aortic aneurysms are dangerous because they can rupture and if this happens up to 90% of people affected will die. Of those who make it to hospital, they have a less than 50% chance of surviving. At present, we use size, measured by an ultrasound scan, to best predict which abdominal aortic aneurysms are most likely to rupture. The problem with this is that sometimes small abdominal aortic aneurysms rupture and large abdominal aortic aneurysms go on to grow to 10cm without rupturing. This suggests that size is not the only factor to cause abdominal aortic aneurysms to grow and rupture. The principal objective of this study is to use magnetic resonance
    E.2.2Secondary objectives of the trial
    This study will look at patients under surveillance for abdominal aortic aneurysms. We will evaluate the uptake of the new imaging agent into the wall of the aneurysm, using an magnetic resonance imaging scan to see if this: 1. correlates with the rate of expansion of the abdominal aortic aneurysm. 2. occurs more commonly in patients who progress to surgery or whose aneurysm subsequently ruptures 3. relates to the amount of stress the abdominal aortic aneurysm is under from the force of blood pushing against it and whether this can predict which abdominal aortic aneurysm will grow at a faster or slower rate. 4. can provide a predictor of risk in addition to standard risk markers, such as smoking and high blood pressure. 5. occurs in a reproducible manner. 6. relates to the degree of new vessel formation and inflammation and how this contributes to abdominal aortic aneurysm growth rate.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Abdominal aortic aneurysms measuring ≥40mm in anteroposterior diameter on ultrasound scanning. 2. Age ≥40 years. Patients with abdominal aortic aneurysms less than 40 years may have a connective tissue disorder and a different aetiology to their disease.
    E.4Principal exclusion criteria
    1. Patients expected to undergo imminent elective or emergency surgical or endovascular repair. 2. Contraindication to magnetic resonance imaging scanning identified from magnetic resonance imaging safety questionnaire, which includes but not limited to: - intracranial aneurysm clips (except Sugita) or other metallic objects - history of intra-orbital metal fragments that have not been removed - pacemakers, implantable cardiac defibrillators and non-MR compatible heart valves - inner ear implants - history of claustrophobia in MR - allergy to MRI contrast enhancement agent 3. Patients refusing or unable to give informed consent 4. Woman with child-bearing potential will not be enrolled into the trial (woman who have experienced menarche, are pre-menopausal, have not been sterilised or who are currently pregnant). 5. Intercurrent illness including patients with a systemic inflammatory disorder or underlying malignancy (life expectancy < 2 years). 6. Renal dysfunction (eGFR ≤30 mL/min/1.73m2). 7. Polycythemia. 8. Contraindication to ferumoxytol (evidence of iron overload, known hypersensitivity to ferumoxytol or its components or anaemia not caused by iron deficiency).
    E.5 End points
    E.5.1Primary end point(s)
    To determine whether mural uptake of USPIO provides incremental risk prediction in addition to standard risk markers such as aneurysm diameter, smoking and blood pressure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 month follow up.
    E.5.2Secondary end point(s)
    1. The correlation between rate of aneurysm expansion and mural uptake of USPIO on MRI scanning. 2. To identify whether mural uptake of USPIO in MRI scanning occurs more commonly in patients who progress to surgery or whose aneurysm subsequently ruptures 3. The correlation between areas of biomechanical stress and mural uptake of USPIO on MRI scanning. 4. To identify whether mural uptake of USPIO in MRI scanning occurs in a reproducible manner.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Points 1-3: 24 months follow up. Point 4: evaluation at 1 month and 1 year.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned3
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    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.1.1Number 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: 115
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 234
    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 state350
    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)
    Ultrasound screening is routinely used in the follow-up of patients with abdominal aortic aneurysms and this will continue to be provided, as clinically indicated after the end of the trial.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-21
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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