FERRIC DERISOMALTOSE for Chronic heart failure | Iron deficiency

Inclusion criteria

• {"criterion_text":"- 1. Subjects aged ≥18 years at the time of signing the ICF\n- 2. LVEF of ≤45 %\n- 3. History of heart failure and NYHA class II, III or IV\n- 4. Hb ≥9 g/dL and ≤13 g/dL for women; ≥9 g/dL and ≤14 g/dL for men\n- 5. TSAT <20 %\n- 6. On maximally tolerated guideline-directed medical therapy for heart failure as determined by Investigator\n- 7. Evidence of being in a higher risk heart failure group: •\tCurrently hospitalized for worsening heart failure (hemodynamically stabilized and expected to survive to discharge). Hospital admission with, or complicated by signs of, worsening heart failure that has resulted in the use of IV diuretics or initiation of or a substantial increase in medication used to treat heart failure (e.g., increase in oral diuretics by 40 mg or more for furosemide or 1 mg or more for bumetanide and/or the addition of a thiazide like diuretic or the addition of a mineralocorticoid receptor antagonist and/or the addition of a sodium-glucose co-transporter 2 inhibitor and/or the addition of sacubitril/valsartan) •\tHemodynamically stable CHF subjects identified in outpatient ambulatory services/practice or emergency departments with elevated natriuretic peptides: NT-proBNP >500 pg/mL in sinus rhythm or >1,000 pg/mL in atrial fibrillation (or BNP of >150 pg/mL or 300 pg/mL, respectively)\n- 8. At least 1 of the following prognostic enrichment criteria: •\tMedical history of ischemic heart failure etiology, and/or prior AMI, and/or prior coronary revascularization o eGFR ≤45 mL/min/1.73 m² o TSAT ≤15 % •\tAnemia as defined by a Hb of ≥9 and <12 g/dL for women and ≥9 and <13 g/dL for men\n- 9. Willingness to participate and signing the ICF"}

Exclusion criteria

• {"criterion_text":"- 1. eGFR <15mL/min/1.73m² or on renal replacement therapy\n- 10. Received an investigational drug and/or invasive device within 30 days or 5 half-lives, whichever is longer, prior to screening\n- 11. Treatment with IV or IM iron within 6 months prior to screening\n- 12. Treatment with radiotherapy, chemotherapy or other drugs that suppress the bone marrow, and drugs which have anemia as side effect within 90 days prior to screening\n- 13. Any non-viral infection (non-viral infection that has been fully treated before the baseline visit is accepted)\n- 14. Any other laboratory abnormality (known B12 or folate deficiency should be corrected but do not exclude the subject), medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject’s disease management at risk or may result in the subject being unable to comply with the trial requirements.\n- 2. Chronic defined need for IV iron therapy\n- 3. Likely to need or already receiving ESA\n- 4. Any of the following cardiovascular comorbidities: •\tPlanned cardiac surgery or revascularization or cardiac device implantation •\tWithin 3 months of screening any of the following: a primary diagnosis of type 1 myocardial infarction (excluding small troponin elevations in the context of heart failure admissions), cerebrovascular accident, major cardiovascular surgery or percutaneous coronary intervention, or blood/plasma transfusion •\tOn active cardiac transplant list •\tLeft ventricular assist device implanted\n- 5. Any of the following other comorbidities: •\tOther disease with life expectancy of <2 years •\tActive clinically relevant bleeding in the Investigator’s opinion •\tKnown or suspected gastrointestinal malignancy\n- 6. Pregnant or nursing women. To avoid pregnancy, women of childbearing potential must agree to use contraception as described in Section 16 during the whole trial period and at least 7 days after the last dosing if the subject decides to withdraw\n- 7. Previous serious hypersensitivity reactions to any IV iron compounds including ferric derisomaltose\n- 8. Iron overload or disturbances in utilization of iron (e.g., haemochromatosis, hemosiderosis)\n- 9. ALAT and/or ASAT >3 times upper limit of normal"}

Primary endpoints

• {"endpoint_text":"- Primary efficacy endpoint: Number of cardiovascular deaths and hospitalizations for worsening heart failure","definition_or_measurement_approach":"No further detailed definition or measurement approach is provided in the available Part I data; endpoint is specified as a count of cardiovascular deaths and hospitalizations for worsening heart failure."}

Secondary endpoints

• {"endpoint_text":"- Key Secondary efficacy endpoints: • Time to first hospitalization for worsening heart failure or cardiovascular death\n- Key Secondary efficacy endpoints: • Number of hospitalizations for worsening heart failure\n- Key Secondary efficacy endpoints: • Number of all-cause hospitalizations\n- Key Secondary efficacy endpoints: • Time to cardiovascular death\n- Key Secondary efficacy endpoints: • Time to all-cause death\n- Secondary efficacy endpoints: • Number of hospitalizations for cardiovascular, respiratory, or renal disease\n- Secondary efficacy endpoints: • Time to cardiovascular, respiratory, or renal death\n- Secondary efficacy endpoints: • Number of hospitalizations for cardiovascular events: stroke, acute myocardial infarct (AMI), and heart failure\n- Secondary efficacy endpoints: • Time to cardiovascular death or first hospitalization for cardiovascular event: stroke, AMI, and heart failure\n- Secondary efficacy endpoints: • Time to all-cause death or first hospitalization\n- Secondary efficacy endpoints: • Days hospitalized or dead for cardiovascular reasons at week 52\n- Secondary efficacy endpoints: • Days hospitalized or dead for any reason at week 52\n- Secondary efficacy endpoints: • Change in New York Heart Association (NYHA) from baseline to weeks 12, 26, and 52\n- Secondary efficacy endpoints: • All-cause rehospitalizations at 30 and 60 days\n- Secondary efficacy endpoints: • Rehospitalizations for worsening heart failure at 30 and 60 days\n- Secondary efficacy endpoints: • Number of cardiovascular deaths and hospitalizations for worsening heart failure including urgent and unscheduled outpatient IV diuretic treatment\n- Secondary efficacy endpoints: • Number of urgent and unscheduled outpatient IV diuretic treatment\n- PD endpoint: Change in Hb, s-ferritin, TSAT, s-iron, and TIBC from baseline to weeks 26 and 52\n- Safety endpoints: • Type and incidence of serious adverse events (SAEs)\n- Safety endpoints: • In addition, vital signs and safety laboratory parameters will be measured as part of standard safety assessments.","definition_or_measurement_approach":"Definitions/measurement approaches are not fully specified in the Part I data; many endpoints are time-to-event or counts (e.g., time to first hospitalization or death; number of hospitalizations); PD endpoints list specific laboratory measures (Hb, s-ferritin, TSAT, s-iron, TIBC) to be measured at baseline and weeks 26 and 52; safety endpoints include SAE type/incidence and vital signs/lab parameters as part of standard safety assessments."}

Methods

• Site-based recruitment via participating hospitals/clinics and cardiology departments (local investigators and HCP referrals) as implied by site lists.
• Printed recruitment materials (posters, brochures, patient letters, HCP letters, print ads) prepared and localized per country (documents labelled e.g., K2_* Recruitment Material for CZ, LT, PT, SK, RO, DK, NO, HU, PL, HR, BG, LV etc.).
• Local site patient-facing materials including Appointment Reminder Cards and Patient Participation Cards (document titles L2_* Appointment Reminder Card, Subject Participation Card).
• Direct provider outreach: 'Dear Colleague' / HCP factsheets to engage referring clinicians (document titles K2_* HCP Factsheet / Dear Colleague Letter in some countries).
• Scout and mailer activities: 'scout' emails and mailers to potential participants (documents titled 'Scout Email', 'Scout Mailer', 'Scout Study Brochure').

Czechia

Earliest CTIS Part Ii Submission Date

22-05-2025

Latest Decision Or Authorization Date

20-06-2025

Processing Time Days

29

Number Of Participants

65

Lithuania

Earliest CTIS Part Ii Submission Date

23-05-2025

Latest Decision Or Authorization Date

20-06-2025

Processing Time Days

28

Number Of Participants

62

Portugal

Earliest CTIS Part Ii Submission Date

18-03-2025

Latest Decision Or Authorization Date

20-06-2025

Processing Time Days

94

Number Of Participants

70

Slovakia

Earliest CTIS Part Ii Submission Date

30-04-2025

Latest Decision Or Authorization Date

19-06-2025

Processing Time Days

50

Number Of Participants

70

Romania

Earliest CTIS Part Ii Submission Date

18-03-2025

Latest Decision Or Authorization Date

24-06-2025

Processing Time Days

98

Number Of Participants

105

Denmark

Earliest CTIS Part Ii Submission Date

10-02-2026

Latest Decision Or Authorization Date

24-02-2026

Processing Time Days

14

Number Of Participants

51

Norway

Earliest CTIS Part Ii Submission Date

06-02-2026

Latest Decision Or Authorization Date

11-02-2026

Processing Time Days

5

Number Of Participants

47

Hungary

Earliest CTIS Part Ii Submission Date

28-04-2025

Latest Decision Or Authorization Date

20-06-2025

Processing Time Days

53

Number Of Participants

46

Poland

Earliest CTIS Part Ii Submission Date

23-05-2025

Latest Decision Or Authorization Date

24-06-2025

Processing Time Days

32

Number Of Participants

180

Croatia

Earliest CTIS Part Ii Submission Date

09-06-2025

Latest Decision Or Authorization Date

24-06-2025

Processing Time Days

15

Number Of Participants

81

Bulgaria

Earliest CTIS Part Ii Submission Date

10-06-2025

Latest Decision Or Authorization Date

20-06-2025

Processing Time Days

10

Number Of Participants

280

Latvia

Earliest CTIS Part Ii Submission Date

26-05-2025

Latest Decision Or Authorization Date

25-06-2025

Processing Time Days

30

Number Of Participants

65

Primary sponsor

Full Name

Pharmacosmos A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

Medidata Solutions Inc.

Responsibilities

sponsorDuties codes: [7] (as listed in CTIS record)

Name

Icon Clinical Research Limited

Responsibilities

sponsorDuties codes: [1,10,12,13,15 (Adjudication),2,3,4,5,6,8] (as listed in CTIS record; includes 'Adjudication')

Name

Klifo A/S

Responsibilities

sponsorDuties codes: [14]

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1,10,12,13,15 (Adjudication),2,3,4,5,6,8]","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Klifo A/S","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}