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    Summary
    EudraCT Number:2018-000767-91
    Sponsor's Protocol Code Number:
    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:2018-06-14
    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 number2018-000767-91
    A.3Full title of the trial
    INtravenous Iron to Treat Anaemia in CriTical Care Survivors (INTACT): a feasibility study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    INtravevous Iron to Treat Anaemia in CriTical Care Survivors (INTACT): a feasibility study
    A.3.2Name or abbreviated title of the trial where available
    INtravenous Iron to Treat Anaemia in CriTical Care Survivors (INTACT)
    A.4.1Sponsor's protocol code number
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1209-6873
    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 Oxford / Clinical Trials and Research Governance
    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 supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointAkshay Shah
    B.5.3 Address:
    B.5.3.1Street AddressJohn Radcliffe Hospital, Headley Way
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX3 9DU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865387906
    B.5.6E-mailakshay.shah@ndcls.ox.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 Ferric carboxymaltose
    D.2.1.1.2Name of the Marketing Authorisation holderVifor
    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 nameFerric carboxymaltose
    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.3.8INN - Proposed INNFerric carboxymaltose
    D.3.9.1CAS number 1461680-64-7
    D.3.9.3Other descriptive nameFerinject
    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 number50
    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
    Anaemia in survivors of intensive care
    E.1.1.1Medical condition in easily understood language
    Anaemia is a reduction in the blood count or haemoglobin levels. Haemoglobin is a protein responsible for carrying oxygen around the body and symptoms of anaemia including fatigue and lethargy.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002034
    E.1.2Term Anaemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002062
    E.1.2Term Anaemia iron deficiency
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10022519
    E.1.2Term Intensive care
    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
    This is a feasibility study aiming to find out whether it is possible to give intravenous (through a drip) iron to patients with anaemia (low blood count) who have survived intensive care (ICU). A feasibility study is a short trial with a small number of people taking part, to help us decide how a larger study would work. Important questions that we are asking in this feasibility study are
    (i) How easy is it to recruit participants?
    (ii) How easy is it to collect the relevant information we would need for a future large trial?

    Our ultimate aim is to complete a larger trial which will test whether or not intravenous iron will treat anaemia in ICU survivors and improve quality of life after discharge from hospital. This would require external funding and be a separate ethics application.
    E.2.2Secondary objectives of the trial
    Secondary outcomes will include collecting information on the following outcomes that we feel are important to both patients and doctors:
    (i) Clinical outcomes - new infection, hospital length of stay, readmission to intensive care and in-hospital death
    (ii) Laboratory outcomes - changes in blood counts and iron profiles
    (iii) Completion rates of health-related quality of life questionnaires
    (iv) Healthcare resource use after discharge from hospital

    We anticipate the information collected above will help us make calculations on how many patients we would need for a future, larger trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Adult ICU/HDU (Level 2 or 3) for ≥48 hours and now deemed fit for discharge by the attending physician
    (2) Last measured laboratory haemoglobin ≤100 g/l
    (3) Able to provide written informed consent
    E.4Principal exclusion criteria
    (1) Planned palliative care
    (2) Planned home ventilation
    (3) Primary neurological diagnosis
    (4) Requirement for English translation
    (5) Known hypersensitivity to iron
    (6) Immunosuppressive therapy for organ transplant
    (7) Intravenous iron or erythropoietin in the previous 4 weeks
    (8) Weight ≤ 50 kg
    (9) Already enrolled into another trial where the trial protocol explicitly prohibits co-enrolment
    (10) Pregnancy (however, breastfeeding is not an exclusion criteria)
    (11) Personal or family history of iron overload disorders such as haemachromatosis or previously documented ferritin >1200 ng.ml-1 and/or Tsat >50%.
    (12) History of severe asthma, eczema, or other atopic allergy
    (13) Chronic liver disease and/or screening Alanine Transferase / Aspartate Transferase x3 above upper limit of normal range
    (14) Haemodialysis dependent chronic kidney disease
    (15) Acute infection – non-resolving temperature ≥ 38°C within the past 24 hours or patient on non-prophylactic antibiotics
    (16) Patients residing outside a reasonable geographic follow-up area (e.g. defined as within approximately 30 miles of the John Radcliffe Hospital or Edinburgh Royal Infirmary)
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective for this study is to assess the feasibility of a future large multicentre trial of intravenous iron to treat anaemia in ICU survivors. The following outcomes will be measured:
    (1) Recruitment and randomisation rates
    (2) Number of participants randomised to the study drug who actually go on to receive it (protocol adherence)
    (3) Completion rates of health related quality of life and health economic questionnaires
    E.5.1.1Timepoint(s) of evaluation of this end point
    The recruitment period is 52 weeks. Data will be collected at baseline (pre-randomisation) and at 28 and 90 days post-randomisation.
    E.5.2Secondary end point(s)
    (1) Clinical outcomes - new infection, mortality, hospital length of stay (LOS), ICU and hospital readmissions, blood product use

    (2) Laboratory data – changes from baseline to 28 and 90 days post-randomisation in the following – haemoglobin, iron profile (ferritin, serum iron, Transferrin saturation (Tsat (%)), urea and electrolytes (U&Es), liver function tests (LFTs), bone profile, C-reactive protein, erythropoietin (EPO), Vitamin D, hepcidin, soluble transferrin receptor (sTfR)

    (3) Healthcare resource use – primary healthcare use post-hospital discharge, societal costs and productivity losses

    (4) Health-related quality of life – MFI-20, FACIT-F and EQ-5D-5L questionnaires
    E.5.2.1Timepoint(s) of evaluation of this end point
    The recruitment period is 52 weeks. Data will be collected at baseline (pre-randomisation) and at 28 and 90 days post-randomisation.
    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 Yes
    E.6.4Safety Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Usual care
    E.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    The end of trial will be when the 90-day follow-up for the last recruited participant has taken place.
    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 months7
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days1
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 130
    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)
    There is no continued provision of the intervention after the research has finished. Patients may receive iron as part of treatment for another condition or as part of usual care by their GP or other healthcare professional.
    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 N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-16
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