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    Summary
    EudraCT Number:2019-004370-26
    Sponsor's Protocol Code Number:R2451
    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:2019-12-03
    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 number2019-004370-26
    A.3Full title of the trial
    Exploratory single centre prospective 12-week comparative double blinded randomised trial of the impact of high-dose iron isomaltoside vs iron carboxymaltose on measures of FGF23, bone metabolism and Hb in patients with Chronic Kidney Disease and iron deficiency.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intravenous Iron Products and Phosphaturia in patients with Chronic Kidney Disease
    A.3.2Name or abbreviated title of the trial where available
    Iron and Phosphaturia Trial (ExplorIRON-CKD)
    A.4.1Sponsor's protocol code numberR2451
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1240-0643
    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 University Teaching Hospitals NHS 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 supportPharmacosmos A/S
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHull University Teaching Hospitals NHS Trust
    B.5.2Functional name of contact pointProf Sunil Bhandari
    B.5.3 Address:
    B.5.3.1Street Address2nd Flood Alderson House - Anlaby Road
    B.5.3.2Town/ cityKingston Upon Hull
    B.5.3.3Post codeHU3 2JZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01482605260
    B.5.6E-mailsunil.bhandari@hey.nhs.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 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
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNiron (III) isomaltoside 1000
    D.3.9.1CAS number 9004-66-4
    D.3.9.2Current sponsor codeIron oligosaccharide complex
    D.3.9.3Other descriptive nameMonofer
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2000
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Ferinject
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameFerinject
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFerric Carboxymaltose
    D.3.9.1CAS number 9007-72-1
    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
    Iron deficiency anaemia associated with Chronic Kidney Disease
    E.1.1.1Medical condition in easily understood language
    Anaemia because of low iron associated with chronic kidney disease
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066763
    E.1.2Term Chronic iron deficiency 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 PT
    E.1.2Classification code 10022972
    E.1.2Term Iron deficiency 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 10055738
    E.1.2Term Iron deficiency anaemia, unspecified
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10072681
    E.1.2Term Fibroblast growth factor 23
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore whether iron loading with third generation IV iron preparation differentially causes an increase in FGF23 and subsequent reduction in serum phosphate and this may impact markers of bone metabolism which may have longer term implications
    E.2.2Secondary objectives of the trial
    1: To test and explore the difference that may arise between the use of two different iron preparations in bone markers (1,25 Vitamin D, calcium, PTH, ALP, bone specific ALP and serum phosphate) and monitor the tolerance and safety of it (by monitoring events of hypophosphataemia)

    2: To test and explore the difference that may arise between the use of two different iron preparations in haemoglobin response and ferritin levels

    3: To test and explore the cardiac impact that may arise secondary to the difference in iFGF23 release caused by different iron preparations using cardiac biomarkers (troponin T and NT-pro BNP), pulse wave velocity measurements and ECG

    4: To test and explore the impact that different iron preparations may have on this cohort of patients with regards to functional status via the use of accredited functionality scores such as the Fatigue Severity Scale and the Kidney Disease Quality of Life Instrument (KDQOL)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women aged ≥18 years;
    • Patients with stable CKD eGFR > 20 ml/min/1.73m2
    • Resting BP ≤ 160/95mmHg;
    • Able to give written and signed informed patient consent;
    • Able to complete study assessments;
    • Ferritin level less than 200µg/L OR transferrin saturation ≤20% and serum ferritin between 200-299µg/L;
    • Haemoglobin less than 150g/L;
    • Serum phosphate > 0.8 mmo/L;
    • A negative pregnancy test for females of child bearing potential;
    • For a female of child bearing potential must agree to acceptable birth control from screening through to Visit 8
    E.4Principal exclusion criteria
    • Age < 18 years;
    • Pregnancy or lactation;
    • Weight ≤ 70kg; if Hb is ≥ 100 g/L;
    • Bleeding (> 500 ml) or surgery in the 30 days prior to recruitment;
    • 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;
    • 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 in last 6 weeks;
    • Patients with known haemoglobinopathy, myelodysplasia, myeloma;
    • Involvement in another CTIMP within the past four weeks.
    E.5 End points
    E.5.1Primary end point(s)
    The percentage change in iFGF23 from baseline to 1-2 days post-infusion between iron isomaltoside and ferric carboxymaltose.

    Percentage change in iFGF23 from baseline to 2 weeks post-infusion between iron isomaltoside and ferric carboxymaltose.

    Co-primary outcome: Composite of change in iFGF23 and delta change in phosphate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary outcome time-point of evaluation: %change in iFGF23 from baseline to 1-2 days post infusion between two IMPs used.

    Co-primary endpoints:
    % change in iFGF23 from baseline to 2 weeks post-infusion; composite change in iFGF23 and delta change in phosphate at all time interventions.
    E.5.2Secondary end point(s)
    As per outcomes:
    Difference between the two treatments on bone markers (1,25 Vit D, calcium, PTH, ALP, bone specific ALP and serum phosphate levels) at each study visit and comparison to end.
    Difference in Pulse Wave Velocity Measurement between baseline and end-point
    Incidence of hypophosphataemia (<0.65 mmol/L) and severe hypophosphataemia (<0.3mmol/L)
    Markers of anaemia response (Hb, ferritin, TS%) at each study visit and comparison to end.
    Difference in functional status (KQDOL and Fatigue Severity Scale) between baseline, when performed and at end-point
    Effect on cardiac biomarkers (Troponin T and NT-proBNP) at each visit performed and in the case of troponin before and after infusion
    Effect on ECG: changes in PR interval, QRS duration, QTc, features of ischaemia on every visit performed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At each visit comparative analysis and to end point. Variables to be compared when performed with baseline measurement. In the case of troponin: at each visit and before and after infusion of iron. Comparative analysis and end-of-trial analysis for all parameters analysed between baseline and end and in-between iron preparatons.
    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 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 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 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) Yes
    E.8.2.2Placebo No
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    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 months0
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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 defined period of study (3 months following intervention - first intravenous iron infusion) the patients will continue to receive normal follow up by their primary physicians - if deemed appropriate by their primary physician treatment with intravenous iron will continue. Any cardiological findings noted during study implementation will be reported and patients associated will be referred to the dedicated cardiology services of the Trust at a timely fashion.
    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 Clinical Research Network Yorkshire and the Humber
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-14
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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