A Phase III, Randomized, Open-label, Blinded Endpoint, Comparative Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years or older

• Both women and men can join

• Heart failure that causes fatigue, shortness of breath, or other symptoms during physical activity

• Have left ventricle (chamber) ejection fraction (pumping ability) that is 45% or less

• Have low iron levels in the blood

• New York Heart Association (NYHA) Heart Failure Classification II, III or IV

Locations
United States
California
Private clinic
RECRUITING
Pasadena
Contact Information
Primary
Pharmacosmos Clinical and non-clinical Department
info@pharmacosmos.com
+45 5948 5959
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 1900
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Pharmacosmos A/S

This content was sourced from clinicaltrials.gov

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