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    Summary
    EudraCT Number:2021-005383-22
    Sponsor's Protocol Code Number:Kognition
    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:2022-03-30
    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 number2021-005383-22
    A.3Full title of the trial
    Cognitive Function, Depression, Anxiety, and Quality of Life in Chronic Heart Failure Patients with Iron Deficiency with and without Anaemia: Effects of Intravenous Iron (Ferric Derisomaltose)

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cognitive Function, Depression, Anxiety, and Quality of Life in Chronic Heart Failure Patients with Iron Deficiency with and without Anaemia: Effects of Intravenous Iron (Ferric Derisomaltose)
    A.3.2Name or abbreviated title of the trial where available
    CogFer Study
    A.4.1Sponsor's protocol code numberKognition
    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 SponsorUniversitätsmedizin Göttingen
    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 supportPharmacosmos A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsmedizin Göttingen
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressRobert-Koch-Str. 40
    B.5.3.2Town/ cityGöttingen
    B.5.3.3Post code37075
    B.5.3.4CountryGermany
    B.5.4Telephone number+4955139 20912
    B.5.5Fax number+4955139 20918
    B.5.6E-mailstephan.von.haehling@med.uni-goettingen.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 MonoFer 100 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacosmos A/S
    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 nameMonoFer 100 mg/ml
    D.3.4Pharmaceutical form Solution for 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 INNFerric derisomaltose
    D.3.9.1CAS number 9004-66-04
    D.3.9.3Other descriptive nameIron (III) ironmaltoside 1000
    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.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 placeboInfusion
    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
    Iron deficiency in patients with chronic heart failure and mild cognitive impairment
    E.1.1.1Medical condition in easily understood language
    Iron deficiency in patients with chronic heart failure and mild cognitive impairment
    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
    The primary objective of the study is to evaluate the effect of iron repletion with intravenous Ferric Derisomaltose on cognitive function as assessed using a composite score of cognitive function, in patients with stable chronic heart failure (NYHA class II-III, left ventricular ejection fraction ≤ 40 %) and iron deficiency.
    E.2.2Secondary objectives of the trial
    Not applicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The Patient is willing and able to participate and provides written informed consent;
    2. Age ≥ 18 years and < 85;
    3. NYHA II-III functional class due to stable symptomatic chronic HF and all of the following;
    4. Three months without cardiac hospitalization;
    5. Patients in NYHA II: acute care admission or emergency room visit for worsening HF at least once within 24 months prior to start of treatment, but not in the last three months;
    6. Appropriate dose of medical therapy for HF (such as ACEi, ARB, ß-blocker, oral diuretics, MRA, ARNI, ivabradine) consistent with prevailing local and international CV guidelines.
    7. No dose changes of HF drugs during the last 2 weeks (exception for diuretics);
    8. No introduction of a new HF drug class during the last 4 weeks;
    9. LVEF ≤ 40 % for both groups of NYHA functional classes; documented within the last 12 months prior to screening;
    10. At screening or Visit 1, significantly raised plasma levels of natriuretic peptides (NT-proBNP ≥ 600 pg/ml or BNP ≥ 150 pg/ml) or if they have been hospitalized for HF within the previous 12 months, a NT-proBNP ≥ 400 pg/ml or BNP of at least 100 pg/ml or by patients with atrial fibrillation and HF, a NT-proBNP ≥ 900 pg/ml;
    11. Screening ferritin < 100 ng/ml OR ferritin 100-299 ng/ml if TSAT < 20 %;
    12. Hb: ≥10 < 15.0 g/dl
    13. Patient must be able to perform the 6 minute walking distance und handgrip strength measurements according to investigator judgment;
    14. Mild cognitive impairment according to MoCA Test.  
    E.4Principal exclusion criteria
    1. Clinical signs and symptoms of infection or C-reactive protein > 20 mg/l;
    2. Clinically significant bleeding and subject at an immediate need of transfusion;
    3. Active malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia;
    4. History of erythropoetin, IV or oral iron therapy, and blood transfusion in previous 4 weeks;
    5. Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range;
    6. Vitamin B12 and/or serum folate deficiency. If deficiency is corrected, patients may be re-screened for inclusion;
    7. Haemolytic anaemia and other forms of anaemia not based on ID (e.g. other microcytic anaemia, pernicious anaemia);
    8. Known HIV/AIDS;
    9. Currently receiving systemic chemotherapy and/or radiotherapy;
    10. Renal replacement therapy (previous, current or planned within the next 6 month) or haemodialysis;
    11. Severe valvular or left ventricular outflow obstruction disease, obstructive cardiomyopathy;
    12. Atrial fibrillation/flutter with a mean ventricular response rate in rest > 100 bpm;
    13. Uncontrolled hypertension with blood pressure > 160/100 mmHg;
    14. Acute coronary syndrome (STEMI, NSTEMI or unstable angina pectoris), transient ischaemic attack or stroke within the last 3 months;
    15. Coronary-artery bypass graft, percutaneous intervention (cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months or planned during the study;
    16. Implantation of CRT/ICD within the past 3 months or planned during the study;
    17. Subject is pregnant (e.g., positive ß-hCG test) or is breast feeding;
    18. Women in childbearing age and not using medically acceptable effective contraception refer to CTFG*;
    19. History of acquired iron overload or hemochromatosis (or a first relative with hemochromatosis);
    20. Hypersensitivity to the active substance, to FDI or any of its excipients;
    21. Earlier hypersensitivity to parental iron preparations or a history of allergic disorders;
    22. History of severe asthma, eczema or other atopic allergy;
    23. History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis);
    24. Concurrent immunosuppressive therapy;
    25. Psychosis or dementia (latter assessed by DemTect);
    26. Prescribed anti-dementia medication
    27. Diagnosed current severe depressive episode (according to ICD-10-GM).
    E.5 End points
    E.5.1Primary end point(s)
    Changes in cognitive performance at week 12, compared to baseline, as assessed by a global composite score of cognitive function. This score constitutes the average of z-standardized results of the Digit Symbol Substitution Test, Stroop Color Word Interference Task, Trailmaking-Test, CERAD-Wordlist, Digit Span Backwards Test, and Digit Span Forwards Test.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    1. Changes in cognitive performance at week 24, compared to baseline, as assessed by the global composite score of cognitive function.
    2. Changes in single measures of cognitive performance at week 12 and 24 compared to baseline, as assessed by the MoCA Test, Digit Symbol Substitution Test, Stroop Color Word Interference Task, Trailmaking-Test, CERAD-Wordlist, Digit Span Backwards Test, and Digit Span Forwards Test.
    3. Reduction in depression from baseline to week 12 and 24, as assessed by HADS.
    4. Reduction in general anxiety and heart-focused anxiety from baseline to week 12 and 24, as assessed by HADS and HAF-17 and CAQ.
    5. Changes in self-reported quality of life, as assessed by The Kansas City Cardiomyopathy Questionnaire (for HF specific quality of life) and EQ-5D (for general psychological and physical quality of life) from baseline to week 12 and 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    Week 24
    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 No
    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) 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 concerned2
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days7
    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: 26
    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 state36
    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 Decision2022-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-27
    P. End of Trial
    P.End of Trial StatusOngoing
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