Recruiting
Phase 3

Ferric Derisomaltose

Sponsor:

Pharmacosmos A/S

Code:

NCT06929806

Conditions

Chronic Heart Failure

Iron Deficiencies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ferric Derisomaltose

Study Details

Brief 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

Conditions

Chronic Heart Failure

Iron Deficiencies

Study ID

NCT06929806

Start date

May 1, 2025

Status verified date

Jul, 2025

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Planned cardiac surgery or revascularization or cardiac device implantation
  • Pregnant or nursing women
  • Treatment with iron Intravenous (through the vein) or intramuscular (injection in the muscle) within the past 6 months
  • Treatment with radiotherapy or chemotherapy

Study Design

Enrollment

1900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Ferric Derisomaltose

100 mg/mL

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 and Locations

Central contacts

Pharmacosmos Clinical and non-clinical Department

+45 5948 5959info@pharmacosmos.com

Locations

Private clinic

Recruiting

Pasadena, California, United States, 91105

More Information

Sponsor

Pharmacosmos A/S

Last update posted

Jul 23, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pharmacosmos A/S on 2025-07-23.