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    EudraCT Number:2014-004133-16
    Sponsor's Protocol Code Number:IH141
    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:2015-02-17
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2014-004133-16
    A.3Full title of the trial
    Exploratory multicentre prospective double blinded randomised controlled pilot study of the effect of intravenous iron supplementation(Monofer)in iron deficient but not anaemic patients with Chronic Kidney Disease stages 3b or worse on functional status and cardiac structure and function.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Iron and Heart Trial
    A.3.2Name or abbreviated title of the trial where available
    Iron and Heart Trial
    A.4.1Sponsor's protocol code numberIH141
    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 SponsorHull and east Yorkshire Hospitals 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 supportKidney Research UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHull and East Yorkshire Hospitals Trust
    B.5.2Functional name of contact pointProfessor Sunil Bhandari
    B.5.3 Address:
    B.5.3.1Street AddressRenal Dept, Hull Royal Infirmary, Anlaby Road
    B.5.3.2Town/ cityHull
    B.5.3.3Post codeHU3 2JZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01482605260
    B.5.5Fax number01482605256
    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. name Monofer
    D. of the Marketing Authorisation holderPharmacosmos A/S
    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.3.1Product nameMonofer 100mg/ml
    D.3.4Pharmaceutical form Solution for infusion in administration system
    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 1000
    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 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 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 Kidney Disease stages 3b to 5 with iron deficiency
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney Disease
    MedDRA Classification
    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 IV iron supplementation in iron deficient non-anaemic CKD patients improves physical and functional status assessed by the 6MWT and questionnaires (KDQoL and MLHF).
    E.2.2Secondary objectives of the trial
    Improvement in cardiac structure and function. Monitoring of physiological aspects using pulse oximetry and cardiac harness for heart and respiratory rate.

    Change in New York Heart association functional classification (NYHA)

    To investigate cardiac iron loading based on MRI using T2* in a small cohort of patients in a single centre (10 patients)

    To observe improvement in renal function as assessed with eGFR
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    In a separate sub-study, to be performed at Hull and East Yorkshire Hospitals NHS Trust 10 patients will undergo T2* imaging of the heart to assess iron loading of the heart immediately after iron infusion. This is not to examine Monofer® as a tracer substance but direct loading into cardiac myoctyes. Each patient’s baseline data will serve as a control.
    E.3Principal inclusion criteria
    Stage of CKD will be calculated by the 4 point MDRD equation. Patients must have a stable eGFR, as defined by <20% variation in eGFR in the preceding 3 months. It is estimated that approximately 30% of patients will have underlying ischaemic heart disease and be on aspirin therapy, which may contribute to iron deficiency. In both groups, BP will be controlled in participants in the trial to the target pressures outlined by the NICE Hypertension guideline (clinical guideline number 127) and NICE CKD guideline (clinical guideline number 73) (21, 22). The standard blood pressure targets will be used (<140/85mmHg)

    Patients with established CKD (Stages 3b-5) (eGFR using MDRD <45ml/min/1.73m2), not on dialysis.

    Clinically stable (principal investigator’s judgement)

    Resting BP ≤ 160/90mmHg when measured in accordance with British Hypertension Society guidelines.

    Men and women aged 18-80 years

    Able to give a written and signed informed patient consent

    Serum ferritin level less than 100 µg/L AND/OR transferrin saturation ≤20%

    Patient must be in sinus rhythm to allow for accurate echo measurements

    Haemoglobin greater or equal to 110g/L up to and including 150g/L

    If deemed necessary all patients will have had faecal occult blood testing (FOBs) carried out as part of national recommendations to exclude bowel pathology.
    E.4Principal exclusion criteria
    Pregnancy or breast feeding (To avoid pregnancy, women have to be postmenopausal, (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended: Contraceptive pills, intrauterine devices (IUD) contraceptive depot injections (prolonged release gestagen), subdermal implantation, vaginal ring and transdermal patches.

    Age < 18 years

    Known allergy to iron therapy

    Haemochromatosis or history of acquired iron overload

    Parenteral iron therapy within the previous 6 weeks

    Inability to co-operate with study protocol

    CRP > 50 mg/L

    Active infection

    Symptomatic ischaemic heart disease

    Current therapy with ESA agents

    Patients with atrial fibrillation

    Patients with potential confounding factors - cancer, (with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia)

    Patients who are unable or do not wish to give consent.

    Patients being investigated for potential blood loss

    Patients who have received blood transfusions

    Patients with known haemoglobinopathy, myelodysplasia, myeloma,

    Patients with musculoskeletal disease, who the investigator deems unable to carry out the 6MWT.

    Patients who have been involved in another medicinal trial (CTIMP) within the past four weeks
    E.5 End points
    E.5.1Primary end point(s)
    To compare the effect of IV iron versus placebo on changes in physical function based on a 6-minute walk test and qualitative questionnaires in iron deficient non-anaemic chronic kidney disease patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Difference in the co analysis of a 6-minute walk test and questionnaires (KDQoL and Minnesota Living and Heart Failure Questionnaire (MLHF) patient quality of life and wellbeing) between experimental and placebo groups (Group 1) and control groups (Groups 2 and 3).

    E.5.2Secondary end point(s)
    Speckle tracking Echo parameters of cardiac function after 6MWT
    Hospitalisation rates from any cause in each group will be noted
    All-cause death and a composite of non-fatal myocardial infarction, stroke, and hospitalisation for heart failure
    All-cause mortality will be recorded
    Cardiovascular events, stroke, non-fatal myocardial infarction will be recorded
    Change in New York Heart association functional classification (NYHA)
    Thrombotic episodes
    Restless leg syndrome questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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. 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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
    At the end of the trial a declaration form will be submitted by the Chief Investigator to the MHRA, REC and HEY R&D within 90 days from completion of the trial and within 15 days if the trial is discontinued prematurely. A summary of the trial final report will be submitted by the Chief Investigator to the MHRA, REC and HEY R&D within 1 year of the end of the study.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days5
    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. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 84
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state84
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 84
    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 intervention medication being tested is routinely available in routine practice therefore, Monofer will always be available to patients who are precribed it by their physicians.
    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 Decision2015-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-21
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