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

NCT06929806 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1900

Last updated 2025-07-23

No results posted yet for this study

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

Interventions

DRUG

Ferric Derisomaltose

100 mg/mL

Sponsors & Collaborators

  • Pharmacosmos A/S

    lead INDUSTRY

Principal Investigators

  • Pharmacosmos Clinical and non-clinical department · Pharmacosmos A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-12-01
Completion
2027-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06929806 on ClinicalTrials.gov