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    Summary
    EudraCT Number:2017-004667-13
    Sponsor's Protocol Code Number:N/A
    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:2018-03-14
    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 number2017-004667-13
    A.3Full title of the trial
    Effect of Iron (III) Isomaltoside 1000 on Cardiac Energetics in Anaemic and Non-anaemic Patients with Symptomatic Chronic Heart Failure and Iron Deficiency: The Ferric Iron in Heart Failure (FERRIC-HF) III Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Iron on Cardiac Energy Levels in Patients with Heart Failure and Iron Deficiency: The Ferric Iron in Heart Failure (FERRIC-HF) III Trial.
    A.3.2Name or abbreviated title of the trial where available
    Ferric Iron in Heart Failure (FERRIC-HF) III Trial
    A.4.1Sponsor's protocol code numberN/A
    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 SponsorKing's College London
    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 supportBritish Heart Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London BHF Centre of Research Excellence
    B.5.2Functional name of contact pointDr Darlington Obinnaya Okonko
    B.5.3 Address:
    B.5.3.1Street AddressJames Black Centre, 125 Coldharbour Lane
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9NU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)20 7848 5017
    B.5.6E-mailobi.okonko@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorKing’s College Hospital NHS Foundation Trust
    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 supportBritish Heart Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London BHF Centre of Research Excellence
    B.5.2Functional name of contact pointDr Darlington Obinnaya Okonko
    B.5.3 Address:
    B.5.3.1Street AddressJames Black Centre, 125 Coldharbour Lane
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9NU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)20 7848 5017
    B.5.6E-mailobi.okonko@kcl.ac.uk
    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 Iron (III) Isomaltoside 1000
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacosmos A/S
    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 nameIron (III) Isomaltoside 1000
    D.3.4Pharmaceutical form Solution for injection/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 INNIron (III) Isomaltoside
    D.3.9.1CAS number 1370654-58-2
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 placeboSolution for injection/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
    Chronic Heart Failure
    E.1.1.1Medical condition in easily understood language
    Chronic Heart Failure
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10022970
    E.1.2Term Iron deficiency
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal research question addressed by this trial is to assess the effect of intravenous repletion of iron on the ability of the heart to produce energy in iron deficient heart failure patients.
    E.2.2Secondary objectives of the trial
    The secondary research questions are the following:
    1. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in exercise capacity
    2. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in cardiac structure and function
    3. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in myocardial iron content
    4. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in blood markers of disease and iron status (e.g., iron status, electrolytes, full blood count, metabolic bloods)
    5. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in symptoms
    6. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in Quality of Life (QoL).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Aged 18 to 89 years
    • Ferritin <100 mcg/l or Ferritin 100 – 300 mcg/l with TSAT <20%
    • Anaemic group (50% of study population): Hb <120 g/L in Females and Hb <130 g/L in Males
    • Non-anaemic group (50% of study population): Hb ≥120 g/L in Females and ≥130 g/L in Males
    • Stable New York Heart Association (NYHA) class II-IV symptoms for the preceding 4 weeks
    • LVEF ≤ 45% assessed by Echocardiography or Cardiac MRI within the preceding 6 months
    • On optimally tolerated heart failure drugs for ≥ 4 weeks with no changes (dose or medication type) for the preceding 2 weeks
    • Resting blood pressure ≤ 160/100mmHg
    • Negative pregnancy test in premenopausal females.
    E.4Principal exclusion criteria
    • Inability to provide written informed consent
    • Inability to sufficiently understand information pertaining to the conduct of the trial
    • Contraindications to 31P-MRS (e.g. pacemaker, metal prosthesis, etc)
    • Ischaemic cardiomyopathy
    • Folate and vitamin B12 levels below laboratory normal limit.
    • Use of erythropoietic agent, blood transfusion or immunosuppressive therapy in the preceding 30 days, or ongoing anticipated need for these agents during the study.
    • Acute or chronic bleeding, infective or inflammatory disorders (Rheumatoid Arthritis, Lupus, HIV/AIDS, malignancy, etc.)
    • History of iron overload or haemochromatosis in patient or first degree relatives.
    • Prior intolerance to intravenous iron formulations or any of their excipients
    • Chronic liver disease and/or aspartate transaminase (AST) >3 times the upper limit of the normal range
    • Renal dialysis (Haemodialysis or peritoneal dialysis)
    • Severe asthma or any severe lung disease with FEV1<50% of predicted or necessitating domicillary oxygen or non-invasive ventilation.
    • Severe atopic disorder including eczema or any prior anaphylactoid / anaphylactic reaction.
    • Haemolytic or myelodysplastic anaemia
    • Severe uncorrected non-functional valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, uncontrolled fast atrial fibrillation or flutter (>110 bpm), uncontrolled symptomatic brady- or tachyarrhythmias.
    • Musculoskeletal limitation that, in the investigators judgement, would impair exercise testing.
    • Pregnant or breast feeding
    • Contemporaneous enrolment in another clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    Cardiac Phosphocreatine to ATP ratio (PCr:ATP) measured by 31Phosphorus Cardiac Magnetic Resonance Spectroscopy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PCr:ATP ratio will be assessed at baseline and at 4 weeks after treatment.
    E.5.2Secondary end point(s)
    1.Change from baseline to week 4 in exercise capacity as assessed by the 6 minute walk distance (6MWD)
    2.Change from baseline to week 4 in cardiac structure and function as assessed using magnetic resonance imaging (MRI) and echocardiography
    3.Change from baseline to week 4 in myocardial iron content as assessed by T2* value on Cardiac MRI.
    4.Change from baseline to week 4 in blood tests (e.g., iron status, electrolytes, full blood count, metabolic bloods)
    5.Change from baseline to week 4 in symptoms (as assessed by New York Heart Association [NYHA] class and Visual Analogue Fatigue Scale [VAFS]).
    6.Change from baseline to week 4 in Quality of Life (QoL) as assessed by the Kansas City Cardiomyopathy Questionnaire [KCCQ].
    7.Number and incidence of adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline and at 4 weeks after treatment allocation
    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 No
    E.6.4Safety No
    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 Yes
    E.6.13.1Other scope of the trial description
    Mechanistic
    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 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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 years1
    E.8.9.1In the Member State concerned months8
    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 months8
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    At the end of the research study, once unblinding has occurred and the treatment allocations are available, all patients randomised to the placebo arm of the trial will be offered iron repletion.
    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 Decision2018-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-24
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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