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    The EU Clinical Trials Register currently displays   44293   clinical trials with a EudraCT protocol, of which   7351   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-005757-12
    Sponsor's Protocol Code Number:FAIR-HFpEF
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-05-02
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-005757-12
    A.3Full title of the trial
    Effect of IV iron (ferric carboxymaltose, Ferinject) on exercise tolerance,
    symptoms and quality of life in patients with heart failure with preserved
    ejection fraction (HFpEF) and iron deficiency with and without anaemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of iron supplementation on symptoms of patient wit heart failure and
    iron deficiency.
    Effekt von Eisen IV (Eisencarboxymaltose [FCM], Ferinject®) auf die Belastungstole-ranz, die Symptome und die Lebensqualität von Patienten mit einer Herzinsuffizienz bei erhaltener Ejektionsfraktion (HFpEF) sowie einer Eisendefizienz mit und ohne Anämie
    A.3.2Name or abbreviated title of the trial where available
    The FAIR-HFpEF Trial
    A.4.1Sponsor's protocol code numberFAIR-HFpEF
    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 SponsorCharité – Universitätsmedizin Berlin
    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 supportVifor Pharma
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité – Universitätsmedizin Berlin
    B.5.2Functional name of contact pointMedizinische Klinik m.S. Kardiologi
    B.5.3 Address:
    B.5.3.1Street AddressAugustenburger Platz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930450 553507
    B.5.5Fax number+4930450 553918
    B.5.6E-mailwolfram.doehner@charite.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 Ferinject
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France SA
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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/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 INNFerrum (III)-Ion
    D.3.9.1CAS number 7705-08-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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
    D.8.3Pharmaceutical form of the placeboSolution for injection/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
    Patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID) with and without anaemia
    E.1.1.1Medical condition in easily understood language
    Patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID) with and without anaemia
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    Primary efficacy endpoint:
    The primary endpoint is the difference in exercise capacity from baseline to visit 5 as assessed by the 6-minute walking test after initiation of therapy (FCM or placebo/saline) in patients with HFpEF and ID
    E.2.2Secondary objectives of the trial
    Secondary endpoints:
    Secondary endpoints include the difference in 6-minute-walking distance (in meters) from baseline to visits 3, 4, 6 and 7 respectively; PGA assessment at visit 3, 4, 5, 6, and 7; change in NYHA functional class from baseline to visit 3, 4, 5, 6, and 7, respectively. Further, improvement of Quality of Life from baseline as well as kidney function and inflammatory parameters will be assessed.Further assessments include differences in plasma levels of blood parameters of kidney function and inflammation, and differences in quality of life from baseline to respective assessment time point as well as the rate of recurrent events of HF hospitalization and death.

    Tertiary endpoints (efficacy):
    Tertiary endpoints are resource use and costs associated with the treatment with IV FCM compared to placebo/saline.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is willing to participate and provides written informed consent;
    2. Age ≥18 years;
    3. Clinical diagnosis of heart failure with preserved ejection fraction (HFpEF) with LVEF ≥45% at screening or within 6 months prior to planned randomisation (assessed by echocardiography or MRI);
    4. Ambulatory for at least 7 days with NYHA class II or III at time of randomisation (the screening visit can take place at the end of a
    hospitalisation);
    5. Treated with a diuretic;
    6. Presence of atrial fibrillation (AF) at screening or randomisation is allowed in 2 out of 4 patients (calculated per centre);
    7. At screening or randomisation, presence of one of the following
    criteria:
    a) hospitalisation with a diagnosis of HF within 12 months prior to planned randomisation; OR
    b) raised plasma levels of natriuretic peptides in a patient with sinus rhythm (i.e. in patients without AF: NT-proBNP >300 pg/mL or BNP >100 pg/mL or MR-proANP >120 pmol/L; in patients with AF: NT-proBNP >600 pg/mL or BNP >200 pg/mL or MR-proANP >250 pmol/l)
    8. Evidence of diastolic dysfunction at screening or randomisation, defined as:
    a) E/E’ >13; OR
    b) LA width ≥38 mm; OR
    c) LA length ≥50 mm; OR
    d) LA area ≥20 cm2; OR
    e) LA volume ≥55 ml; OR
    f) left atrial volume index >28 mL/m2;
    9. Haemoglobin >9.0 g/dL and ≤14.0 g/dL (at screening);
    10. ID with ferritin <100 ng/mL or ferritin 100-299 plus TSAT <20% (at screening);
    11. 6-minute-walking distance at baseline <450 m (average of the last 2 documented tests within 8 weeks prior to planned randomisation that also need to be within 20% of each other).

    E.4Principal exclusion criteria
    1. Unable to sign informed consent
    2. Any prior echocardiography measurement of LVEF <40%;
    3. Clinical signs and symptoms of infection including fever >38°C;
    4. SARS-CoV-2 infection
    5. Use of IV iron, erythropoietin or blood transfusions within the previous 60 days;
    6. Use of concurrent immunosuppressive therapy;
    7. History of acquired iron overload or haemochromatosis (or a first relative with
    haemochromatosis);
    8. Known hypersensitivity to FCM or any other IV iron product;
    9. Known bleeding or haemolytic anemia;
    10. Presence of any condition that precludes exercise testing, such as decompensated
    HF, significant musculoskeletal disease, unstable angina pectoris, obstructive
    cardiomyopathy, severe uncorrected valvular disease, or uncontrolled bradyarrhythmias
    or tachy-arrhythmias;
    11. Probable alternative diagnoses that in the opinion of the investigator could account
    for the patient’s HF symptoms such as severe obesity, primary pulmonary
    hypertension, or chronic obstructive pulmonary disease (COPD); hence, patients with
    the following are excluded:
    a) Severe COPD, i.e. with known FEV1 <50%, requiring home oxygen therapy, or on
    chronic oral steroid therapy;
    b) body mass index ≥40.0 kg/m2;
    12. Presence of uncontrolled atrial fibrillation with resting heart rate >110/min;
    13. Presence of uncontrolled hypertension with blood pressure >160/100 mm Hg;
    14. Renal replacement therapy;
    15. Concurrent therapy with an erythropoiesis stimulating agent;
    16. Known active malignancy;
    17. Known HIV or active hepatitis infection;
    18. Pregnancy;
    19. Patients, who may be dependent on the sponsor, the investigator or the trial sites, have
    to exclude from the trial;
    20. Lack of willingness to storage and disclosure of pseudonymous disease data in the
    context of the clinical trial;
    21. Participation in another clinical trial within previous 30 days and/or anticipated
    participation in another trial during this study;
    22. Inability to fully comprehend and/or perform study procedures in the investigator’s
    opinion;
    23. Persons staying at an institution due to order by a national body or a court of law (in
    accordance with the German Arzneimittelgesetz §40, Abs. 1, S. 3, Nr. 4);
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    The primary endpoint is the difference in exercise capacity from baseline to visit 5 as assessed by the 6-minute walking test after initiation of therapy (FCM or placebo/saline) in patients with HFpEF and ID
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    Secondary endpoints include the difference in 6-minute-walking distance (in meters) from baseline to visits 3, 4, 6 and 7 respectively; Secondary endpoints:
    Secondary endpoints include the difference in 6-minute-walking distance (in meters) from baseline to visits 3, 4, 6 and 7 respectively; PGA assessment at visit 3, 4, 5, 6, and 7; change in NYHA functional class from baseline to visit 3, 4, 5, 6, and 7, respectively. Further, improvement of Quality of Life from baseline as well as kidney function and inflammatory parameters will be assessed.Further assessments include differences in plasma levels of blood parameters of kidney function and inflammation, and differences in quality of life from baseline to respective assessment time point as well as the rate of recurrent events of HF hospitalization and death.

    Tertiary endpoints (efficacy):
    Tertiary endpoints are resource use and costs associated with the treatment with IV FCM compared to placebo/saline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Change in 6min-walking distance to weeks 3, 4, 6 and 7 respectively, adjusted for baseline;
    - Change in PGA assessment at visit 3, 4, 5, 6, and 7;
    - Change in NYHA functional class to visit 3, 4, 5, 6, and 7, respectively, adjusted for baseline;
    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) 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 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 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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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
    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 months67
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months28
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 200
    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)
    After completing all the protocol treatment and visits, patients will continue with regular visits according to usual practice of the clinic.
    In the case of premature termination, the reason for withdrawal must be entered on the appropriate case report form (CRF) page and must be followed for safety and efficacy until one month after discontinuation.
    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 Decision2017-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-12-30
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