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    Summary
    EudraCT Number:2021-000130-33
    Sponsor's Protocol Code Number:ORION-HF
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-16
    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 ConcernedGermany - BfArM
    A.2EudraCT number2021-000130-33
    A.3Full title of the trial
    A pilot study to explore safety, tolerability and efficacy of ORal IrON supplementation with ferric maltol in treating iron deficiency and anaemia in patients with Heart Failure (ORION-HF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ORal IrON supplementation with ferric maltol in patients with Heart Failure
    A.3.2Name or abbreviated title of the trial where available
    ORION-HF
    A.4.1Sponsor's protocol code numberORION-HF
    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 SponsorHannover Medical School
    B.1.3.4CountryGermany
    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 supportNorgine B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHannover Medical School,
    B.5.2Functional name of contact point Depart.of Cardiology and Angiology
    B.5.3 Address:
    B.5.3.1Street AddressCarl-Neuberg-Str. 1
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number+495115323841
    B.5.5Fax number+495115325412
    B.5.6E-mailkardiologie@mh-hannover.de
    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 FERACCRU®
    D.2.1.1.2Name of the Marketing Authorisation holderNorgine B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFerric maltol
    D.3.9.1CAS number 33725-54-1
    D.3.9.4EV Substance CodeSUB170121
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with heart failure, iron deficiency and anaemia with either reduced or preserved left ventricular ejection fraction
    E.1.1.1Medical condition in easily understood language
    Patients with heart failure, iron deficiency and anaemia with either reduced or preserved left ventricular ejection fraction
    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 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 10024106
    E.1.2Term Left heart failure
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10076396
    E.1.2Term Heart failure with preserved ejection fraction
    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 10078289
    E.1.2Term Heart failure with reduced ejection fraction
    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
    Primary objective:
    - To assess the effects of oral ferric maltol on change in haemoglobin levels from baseline to week 16 in heart failure patients with iron deficiency and anaemia
    E.2.2Secondary objectives of the trial
    Secondary objective:
    - To assess the effects of oral ferric maltol on serum ferritin, transferrin saturation, soluble transferrin receptor 1, 6 min walking distance, HRQoL (measured by KCCQ-12), serum NT-proBNP, left and right ventricular function (determined by echocardiography), liver and renal function and NYHA class in heart failure patients with iron deficiency and anaemia

    Assessment of safety:
    - To assess the safety and tolerability of oral ferric maltol in heart failure patients with iron deficiency and anaemia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men, women*, inter/diverse aged ≥ 18 at day of inclusion
    2. Signed written informed consent from patient prior to any study-related procedure and
    willingness to comply with treatment and follow-up procedures
    3. Patients capable of understanding the investigational nature, potential risks and
    benefits of the clinical trial
    4. Patients with chronic heart failure with an LVEF<50% (HFrEF, HFmrEF) or patients
    with chronic heart failure with an EF≥50% (HFpEF) and New York Heart Association
    functional class II-IV
    5. 6 min walk distance >50 m
    6. Mild-to-moderate anaemia and iron -deficiency as defined by a haemoglobin
    concentration ≥8 g/dl and <12 g/dl in females or ≥9 g/dl and <13 g/dl in males, and
    serum ferritin <100 µg/l, or 100-299 µg/l and transferrin saturation <20% at screening
    7. *Women without childbearing potential defined as follows:
    • females before menarche (if applicable)
    • at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral
    oophorectomy or
    • hysterectomy or uterine agenesis or
    • ≥ 50 years and in postmenopausal state > 1 year or
    • < 50 years and in postmenopausal state > 1 year with serum FSH > 40 IU/l and
    serum estrogen < 30 ng/l or a negative estrogen test, both at screening
    or
    *Women of childbearing potential:
    • who are practicing sexual abstinence (periodic abstinence and withdrawal are
    not acceptable) or
    • who have sexual relationships with female partners only and/or with sterile male partners or
    • who are sexually active with fertile male partner, have a negative pregnancy
    test during screening and agree to use reliable methods of contraception** from the time of screening until end of the clinical trial.
    **The following methods of contraception are acceptable): e.g.
    - progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
    - male or female condom with or without spermicide
    - cap, diaphragm or sponge with spermicide
    E.4Principal exclusion criteria
    1. Active haematological disorders other than anaemia and/or iron -deficiency
    2. Other medical condition that according to the investigator’s assessment is causing or
    contributing to anaemia
    3. Active malignancy or currently receiving chemotherapy or radiotherapy
    4. Active infectious disease
    5. Active bleeding
    6. Severe renal insufficiency (GFR < 20ml/min or requiring dialysis)
    7. Severe liver injury as indicated by serum aminotransferases >3 x upper limit of normal
    or bilirubin levels >50 µmol/l
    8. Ongoing oral or intravenous iron supplementation
    9. Concomitant erythropoietin medication
    10. Concomitant therapy with Dimercaprol, Chloramphenicol and Methyldopa
    11. ESA, i.v. iron or blood transfusion administered in last 3 months and oral iron (>100
    mg/day) in previous 4 weeks
    12. Pregnancy or lactation period
    13. Subject has received any investigational medication or any investigational devices
    within 30 days prior to the first dose of study medication or is actively participating in
    any investigational drug/ devices trial, or is scheduled to receive investigational
    drug/devices during the course of the study
    14. Known or suspected hypersensitivity to any of the active substances or any
    excipients of the investigational medicinal product
    15. Known haemochromatosis or other iron overload syndromes
    16. Patients with severe, uncorrected valvular heart disease
    17. Clinical evidence of ACS, TIA or stroke within the last 30 days
    18. CABG, PTCA, cardiac device implant/resynchronisation therapy or major surgery
    leading to significant blood loss within last 30 days
    19. Planned CABG, PTCA, cardiac device implant/resynchronisation therapy or major
    surgery
    20. Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy). Subjects
    with Vitamin B12 or folic acid deficiency who in the opinion of the Investigator are stable
    and asymptomatic will be permitted.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint(s):
    Change in haemoglobin level from baseline to week 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    from baseline to week 16
    E.5.2Secondary end point(s)
    Secondary endpoint(s):
    (1) Change in serum ferritin and transferrin saturation from baseline to week 16
    (2) Change in soluble transferrin receptor 1 from baseline to week 16
    (3) Change in 6 min walking distance from baseline to week 16
    (4) Change in HRQoL (measured by KCCQ-12) from baseline to week 16
    (5) Change in serum NT-proBNP from baseline to week 16
    (6) Change in echocardiographic markers of left ventricular function (left ventricular ejection fraction, left ventricular diameter, left ventricular end-systolic volume index, left ventricular end-diastolic volume index, left ventricular wall thickness, left atrial volume index, global longitudinal strain, markers of diastolic function (E/e’, E/A, deceleration time, IVRT) and right ventricular function (right ventricular diameter, tricuspid annular plane systolic excursion, estimated systolic pulmonary arterial
    pressure) from baseline to week 16
    (7) Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 16
    (8) Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 16
    (9) Change in NYHA class from baseline to week 16

    Assessment of safety:
    (10) Treatment-emergent adverse events (AEs)
    (11) number of drop-outs due to AEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    (1) from baseline to week 16
    (2) from baseline to week 16
    (3) from baseline to week 16
    (4) from baseline to week 16
    (5) from baseline to week 16
    (6) from baseline to week 16
    (7) from baseline to week 16
    (8) from baseline to week 16
    (9) from baseline to week 16
    (10) from start of treatment until FU
    (11) from start of treatment until FU
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned7
    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 years
    E.8.9.1In the Member State concerned months20
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state50
    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)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-19
    P. End of Trial
    P.End of Trial StatusOngoing
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