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    Summary
    EudraCT Number:2019-002661-35
    Sponsor's Protocol Code Number:FERRICCABG01
    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:2019-11-18
    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 number2019-002661-35
    A.3Full title of the trial
    Effect of Iron Isomaltoside on Perioperative Myocardial Injury in Patients Undergoing Coronary Artery Bypass Graft ± Valve Surgery: The Ferric Iron in Coronary Artery Bypass Grafting (FERRIC-CABG) Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FERRIC-CABG: Effect of Iron Isomaltoside in Patients Undergoing Coronary
    Artery Bypass Grafting +/- Valve Surgery.
    A.3.2Name or abbreviated title of the trial where available
    FERRIC-CABG:IRON ISOMALTOSIDE IN CARDIAC SURGERY
    A.4.1Sponsor's protocol code numberFERRICCABG01
    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
    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+440208485238
    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 Hospital NHS Foundation Trust
    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+4402078485238
    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 MONOFER
    D.2.1.1.2Name of the Marketing Authorisation holderPHARMACOSMOS AS, DENMARK
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 placeboInfusion
    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
    Coronary or heart valve disease needing cardiac surgery
    E.1.1.1Medical condition in easily understood language
    Coronary or heart valve disease needing cardiac surgery
    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 10068617
    E.1.2Term Coronary heart disease
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019316
    E.1.2Term Heart valve disorders
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether pre-operative intravenous iron isomaltoside reduces peri-operative myocardial injury (PMI), as reflected by lower troponin T levels over 72 hours, in patients undergoing coronary artery bypass grafting (CABG) +/- valve surgery.
    E.2.2Secondary objectives of the trial
    1. PMI as reflected by creatine kinase (CK)-MB 72 hour AUC
    2. Global tissue anaerobic metabolism reflected by lactate 72 hour AUC
    3. Renal injury reflected by creatinine and estimated glomerular filtration rate (eGFR) 3 day AUC
    4. Hepatic injury reflected by aspartate transaminase (AST) 3 day AUC
    5. Inflammatory burden as reflected by C-reactive protein 3 day AUC
    6. Iron status and haemoglobin
    7. Cardiac function as reflected by LVEF
    8. Symptoms as reflected by New York Heart Association and Canadian Cardiovascular Society class.
    9. Quality of life as reflected by the European quality of life: 5 dimensions-5 levels and the patient global assessment of clinical status (PGA) scores.
    10. Exercise capacity as reflected by 6 minute walk distance
    11. Myocardial energetics, redox status and cardioprotective pathways
    12. Haemodynamic stability as reflected by inotrope score over 72 hours
    13. Length of ITU and total hospital stay
    14. Post-op complications
    15. Adverse events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Aged 18 to 89 years
    • Able to provide written informed consent
    • Eligible and scheduled for elective on-pump CABG ± valve surgery
    • Iron deficient (Ferritin<100 µg/L or 100-300 µg/L with TSAT<20%) or
    iron replete (Ferritin 100-300 µg/L with TSAT 20-40% or Ferritin 300-500 µg/L with TSAT≤40%)
    • LVEF ≤ 45% or > 45% on echocardiography within the preceding 3 months
    E.4Principal exclusion criteria
    • Ferritin > 500 mg/ml
    • TSAT>40%
    • Hb > 160 g/L
    • Hb < 90 g/L and/or needing pre-operative blood transfusion
    • Conventional iron deficiency anaemia (Ferritin <20 µg /L and Hb <120 g/L)
    • Pregnant or breast-feeding
    • Use of erythropoietic or immunosuppressive agents in the 30 days preceding screening and/or unwilling or unable to refrain from their use during the trial
    • Acute or chronic bleeding
    • Active infection
    • Active inflammatory condition (e.g. flare up of SLE, rheumatoid, gout, etc)
    • Known iron overload or haemochromatosis in patient or first degree relatives.
    • Prior intolerance to IV iron formulations or any of their excipients
    • Severe atopic disorders including severe asthma, eczema or any prior anaphylactoid / anaphylactic reaction.
    • Haemolytic or myelodysplastic anaemia
    • Enrolment in another clinical trial which might impact FERRIC-CABG
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy analysis will be a comparison of the Troponin T 72 hour area-under-the-curve between all patients who received iron isomaltoside versus all patients who received placebo. This will be done with an unpaired Student t-test or Mann-Whitney U-test depending on data distribution (normal vs non-normal distribution).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Troponin T levels will be taken at baseline prior to CABG, and at 6, 12, 24, 48, and 72 hours post surgery (after coming off bypass).
    E.5.2Secondary end point(s)
    1. CK-MB 72 hour AUC
    2. Lactate 72 hour AUC
    3. Creatinine 3 day AUC
    4. eGFR 3 day AUC
    5. AST 3 day AUC
    6. CRP 3 day AUC
    7. Iron status (ferritin, transferrin saturation [TSAT], serum iron, and total iron binding capacity [TIBC]) on day -1 or 0 prior to induction for surgery
    8. Hb on day -1 or 0 pre-op
    9. Inotrope score over 72 hours
    10. LVEF post-op
    11. NYHA class at post-op clinic
    12. CCS class at post-op clinic
    13. PGA score at post-op clinic
    14. EQ-5D-5L score at post-op clinic
    15. Length of ITU stay
    16. Length of hospital stay
    17. Myocardial biopsy analyses (e.g. myocardial oxygen consumption, antioxidants, redox status, cardioprotective pathways)
    18. 6MWD post-op
    19. Number and incidence of adverse events and post-op complications
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline and on discharge or at 4-12 week post-op outpatient clinic unless stated above.
    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 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) 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 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
    Database lock
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days31
    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: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-11-18. Yes
    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 state240
    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 outpatient visit, all patients will be managed as is clinically appropriate with respect to the need for iron supplementation and blood transfusions.
    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 Decision2020-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-23
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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