Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure

Part of paid clinical trials in Pasadena, California.

Sponsor
Pharmacosmos A/S
Study ID
NCT06929806
Phase
PHASE3
Status
Recruiting
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Conditions

  • Chronic Heart Failure
  • Iron Deficiencies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ferric Derisomaltose — DRUG
    100 mg/mL

Study Details

The goal of this clinical trial is to learn if the IV Iron treatment ferric derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. The main question it aims to answer is: • How many participants are admitted to the hospital or die from a disease in the heart or blood vessels Researchers will compare treatment with ferric derisomaltose to no treatment with ferric derisomaltose. This will be done to see how well ferric derisomaltose works. Participants will: * Be randomized 50/50 to either treatment with Ferric derisomaltose or to no treatment with ferric derisomaltose * All participants receives standard of care * Visit site 4-5 times and have 7 video/phone-calls

Key Dates

Start date
May 1, 2025
Status verified
Jul 2025
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
1,900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ferric Derisomaltose
    50 % of the subjects will be treated with Ferric Derisomaltose 100 mg/mL The ferric derisomaltose dose administered is dependent on the subject's weight and hemoglobin (Hb) level. Subjects treated with ferric derisomaltose will be eligible for re-dosing if transferrin saturation (TSAT) remains below \<25 %
  • No Intervention: Control
    50 % of the subjects will receive no IV iron

Primary Outcome Measure

Number of cardiovascular deaths and hospitalizations for worsening heart failure [ Time Frame: From enrollment to the end of follow-up at 52 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Private clinicPasadenaCalifornia91105
MD

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By research site
Private clinic· Pasadena, CA

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