A Phase 3 interventional study of Ferric Derisomaltose in Chronic Heart Failure and Iron Deficiencies, sponsored by Pharmacosmos A/S. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Pharmacosmos A/S · Phase 3, Interventional, and Treatment
Among 21 studies testing iron isomaltoside 1000 in Iron Deficiencies — 9 open to participants now, 9 under way, 2 of them phase 3. iron isomaltoside 1000 · Iron Deficiencies.
Among the 21 studies testing iron isomaltoside 1000 in Iron Deficiencies, this one has the largest planned enrollment, is one of 4 that started in 2025, is one of 8 in phase 3, and was the 18th registered.
386 studies on the registry are indexed under Iron Deficiencies; 80 are open to participants now.
This study's planned enrollment of 1,900 is above the median of 99 across 301 interventional studies indexed under Iron Deficiencies.
Browse Iron Deficiencies studies →9 of the 21 studies testing iron isomaltoside 1000 in Iron Deficiencies are open now, in 4 countries. Each count lists the studies.
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 55 Iron Deficiencies studies recruiting now, 23 (42%) set no upper age limit and 28 (51%) stop at 75 or younger; 15 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 10 · Phase 4 7
First in 2009; this study’s year is marked. 4 started in 2025.
Median enrollment 170 across the 21 interventional studies. Of the 10 that completed or were terminated, 4 (40%) have results posted.
8 of 21 have an industry lead sponsor. The 10 most frequent:
Pharmacosmos A/S is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
Pharmacosmos A/S has 8 studies filed under Iron Deficiencies — fewer than ten, so there is no comparison to draw.
6 of the studies testing iron isomaltoside 1000 in Iron Deficiencies that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05179226Phase 3Pharmacosmos A/SMulti-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia | 2027-04-30 |
| NCT06287619University Health Network, TorontoPost-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery | 2026-12 |
| NCT07236788China-Japan Friendship HospitalStudy on Supplement of Intravenous Ferric Derisomaltose to Prevent Anemia and Improve the Quality of Life in Obese Patients With Iron Deficiency. | 2026-12-30 |
| NCT05971732China-Japan Friendship HospitalThe Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF) | 2027-08-01 |
| NCT05991128China-Japan Friendship HospitalThe Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life | 2027-08-01 |
Among the 21 studies testing iron isomaltoside 1000 in Iron Deficiencies, from their registry updates:
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:
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
50 % of the subjects will receive no IV iron
100 mg/mL
Number of cardiovascular deaths and hospitalizations for worsening heart failure
Time frame: From enrollment to the end of follow-up at 52 weeks
Number of hospitalizations for worsening heart failure
Time frame: From enrollment and no longer than end of follow-up at 52 weeks
Time to cardiovascular death
Time frame: From enrollment to the end of follow-up at 52 weeks
Number of all-cause hospitalizations
Time frame: From enrollment to the end of follow-up at 52 weeks
Time to all-cause death
Time frame: From enrollment to the end of follow-up at 52 weeks
Time to first hospitalization for worsening heart failure or cardiovascular death
Time frame: From enrollment to the end of follow-up at 52 weeks
Number of hospitalizations for cardiovascular, respiratory, or renal disease
Time frame: From enrollment to the end of follow-up at 52 weeks
Time to cardiovascular, respiratory, or renal death
Time frame: From enrollment to the end of follow-up at 52 weeks
Number of hospitalizations for cardiovascular events: stroke, AMI and heart failure
Time frame: From enrollment to the end of follow-up at 52 weeks
Time to cardiovascular death or first hospitalization for cardiovascular event: stroke, AMI and heart failure
Time frame: From enrollment to the end of follow-up at 52 weeks
Time to all-cause death or first hospitalization
Time frame: From enrollment to the end of follow-up at 52 weeks
Days hospitalized or dead for cardiovascular reasons at week 52
Time frame: From enrollment to the end of follow-up at 52 weeks
Days hospitalized or dead for any reason at week 52
Time frame: From enrollment to the end of follow-up at 52 weeks
Change in NYHA from baseline to weeks 12, 26 and 52
Time frame: From enrollment to weeks 12, 26 and 52
All-cause rehospitalizations at 30 and 60 days
Time frame: From enrollment to 30 and 60 days
Rehospitalizations for worsening heart failure at 30 and 60 days
Time frame: From enrollment to 30 and 60 days
Number of cardiovascular deaths and hospitalizations for worsening heart failure including urgent and unscheduled outpatient IV diuretic treatment
Time frame: From enrollment to the end of follow-up at 52 weeks
Number of urgent and unscheduled outpatient IV diuretic treatment
Time frame: From enrollment to the end of follow-up at 52 weeks
Change in hb, s-ferritin, TSAT, s-iron and TIBC from baseline to weeks 26 and 52
Time frame: From enrollment to weeks 26 and 52
Type and incidence of SAEs
Time frame: From enrollment to the end of follow-up at 52 weeks
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Dec 2027, 31 months after the start.
Of 16 phase 3 interventional studies under Iron Deficiencies, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 60. This study's planned 31 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Iron isomaltoside 1000