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    Summary
    EudraCT Number:2008-001503-26
    Sponsor's Protocol Code Number:FER-CARS-03
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-08-22
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2008-001503-26
    A.3Full title of the trial
    EFfect of Ferric Carboxymaltose on exercIse
    CApacity and Cardiac function in patients with iron
    deficiencY and chronic Heart Failure
    (EFFICACY-HF)
    A.3.2Name or abbreviated title of the trial where available
    EFFICACY-HF
    A.4.1Sponsor's protocol code numberFER-CARS-03
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVifor Pharma - Vifor (International) AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codeVIT-45
    D.3.9.3Other descriptive nameSee IMPD, page 5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    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
    Ambulatory patients with stable symptomatic chronic CHF (congestive heart failure) and iron deficiency.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10002062
    E.1.2Term Anaemia iron deficiency
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to assess, relative to placebo, the effects on the
    evolution of exercise capacity (i.e. 6-minute walk test) and symptomatic status (i.e.
    New York Heart Association classification) of the addition of intravenous iron
    treatment with FCM (ferric carboxymaltose) to the basic regimen of ambulatory
    patients with stable symptomatic chronic CHF (congestive heart failure) and iron
    deficiency.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate the effect of intravenous FCM compared to placebo on:
    1. Evolution from baseline of cardiac function parameters as assessed by 2D
    Echo/Doppler cardiography 4, 12 and 24 weeks after start of study treatment.
    2. Self-reported patient global assessment (PGA) of treatment at 4, 12 and 24
    weeks after start of study treatment.
    3. Health related quality of life (HRQoL) as assessed by the EQ-5D (European
    quality of life – 5 dimensions) and KCCQ (Kansas City Cardiomyopathy
    Questionnaire) self-administered questionnaires 4, 12 and 24 weeks after start of
    study treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At least 18 years of age who have provided written informed consent; In NYHA (New York Heart Association) functional class II or III, Ambulatory and capable of performing a 6-minute walk test; Treated for CHF (congestive heart failure) during at least one hospital, emergency room or acute clinic admission within the last 24 months or brain natriuretic peptide (BNP) ≥ 100 pg/ml or N-terminal pro-hormone brain natriuretic peptide (NT-proBNP) ≥ 400 pg/ml, not older than 8 weeks when study treatment is started; Currently treated for CHF for at least 4 weeks with the same combination of at least two of the following: (a) diuretic, (b) beta-blocker (including carvedilol), (c) ACE (angiotensin converting enzyme inhibitor) or ARB (angiotensin II receptor blocker); Treated during the last 2 weeks with the same dose of drugs given for CHF (dose changes of diuretics are allowed); Resting cuff blood pressures ≤ to 160 mm Hg systolic and ≤ 100 mm Hg diastolic (at the disappearance of sounds, Korotkoff phase V); LVEF (left-ventricular ejection fraction) ≤ 40% assessed locally by 2D Echocardiography; Screening Hb (haemoglobin) value ≥ 9.5 g/dL (5.9 mmol/L), and ≤ 13.5 g/dL (8.4 mmol/L). Screening ferritin below 100 μg/L (224.7 pmol/l), or below 300 μg/L (674.1 pmol/l) when TSAT (transferrin saturation) is below 20%; Use of adequate contraceptive methods for women of childbearing potential.
    E.4Principal exclusion criteria
    Unstable angina pectoris; Walking distance limited by intermittent claudication; Significant valvular disease or left ventricular outflow obstruction; Poorly controlled rapid atrial fibrillation or flutter, symptomatic brady- or tachyarrhythmia; Chronic liver disease; Active infection, clinically significant bleeding, life expectancy reduced by malignancy or known HIV/AIDS (human immunodeficiency virus/acquired immune deficiency syndrome); Anaemia due to reasons other than iron deficiency (e.g. haemoglobinopathy); On immunosuppressive therapy or renal dialysis; Pregnant or lactating; Hospitalisation, emergency room or acute clinic admission for CHF within the last 2 weeks; AMI (acute myocardial infarction) or CVA (cerebrovascular accident) within the last 12 weeks; PCI (percutaneous coronary intervention), CABG (coronary artery bypass graft), major surgery, CRT, ICD or ICD-CRT implantation within the last 12 weeks (diagnostic angiography is allowed); History of acquired iron overload or hypersensitivity to FCM (ferric carboxymaltose) or to any of its excipients; Erythropoiesis Stimulating agents (ESAs), i.v. or blood transfusion administered within the last 12 weeks, or oral iron therapy within the last 30 days; Participation in another clinical trial within the last 30 days; Inadequate quality for central analysis of locally recorded 2D Echo/Doppler cardiograms; Screening ALT (alanine transaminase) or AST (aspartate aminotransferase) > three times the local upper limit of normal; CRP (C-reactive protein) >20 mg/L; Immunosuppressive therapy, renal dialysis, EPO, i.v. or oral iron therapy, or blood transfusion planned; Present abuse of alcohol or drugs; Anticipated participation in another trial during this trial; Inability to fully comprehend and/or comply with trial procedures in the investigator’s opinion.
    E.5 End points
    E.5.1Primary end point(s)
    In accordance with this trial’s primary objective, the two co-primary outcomes are:
    1. Evolution from baseline of the distance covered during 6MWTs (6-minute walk
    tests) performed 4, 12 and 24 weeks after the start of study treatment.
    2. Evolution from baseline in NYHA (New York Heart Association) functional class
    assessments performed at 4, 12 and 24 weeks after the start of study treatment.
    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 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 Yes
    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) Yes
    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.8.3 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months16
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months16
    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.1.3Elderly (>=65 years) Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 330
    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 Decision2008-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-10-31
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