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

NCT06929806 | Recruiting Phase 3 FDA Drug

• 1 other identifier: P-Monofer-CHF-02
• Study Type: interventional
• Target: 1,900
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of cardiovascular deaths and hospitalizations for worsening heart failure

  From enrollment to the end of follow-up at 52 weeks

Secondary Outcomes (17)

• Number of hospitalizations for worsening heart failure

  From enrollment and no longer than end of follow-up at 52 weeks

• Time to cardiovascular death

  From enrollment to the end of follow-up at 52 weeks

• Number of all-cause hospitalizations

  From enrollment to the end of follow-up at 52 weeks

• Time to all-cause death

  From enrollment to the end of follow-up at 52 weeks

• Time to first hospitalization for worsening heart failure or cardiovascular death

  From enrollment to the end of follow-up at 52 weeks

Other Outcomes (2)

• Change in hb, s-ferritin, TSAT, s-iron and TIBC from baseline to weeks 26 and 52

  From enrollment to weeks 26 and 52

• Type and incidence of SAEs

  From enrollment to the end of follow-up at 52 weeks

Study Arms (2)

Ferric Derisomaltose

EXPERIMENTAL

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 %

Drug: Ferric Derisomaltose

Control

NO INTERVENTION

50 % of the subjects will receive no IV iron

Interventions

Ferric Derisomaltose DRUG

100 mg/mL

Ferric Derisomaltose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (1)

Private clinic

Pasadena, California, 91105, United States

RECRUITING

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferric derisomaltose

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pharmacosmos Clinical and non-clinical department

  Pharmacosmos A/S

  STUDY DIRECTOR

Central Study Contacts

Pharmacosmos Clinical and non-clinical Department

CONTACT

+45 5948 5959; info@pharmacosmos.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)