18 and older, any sex, with Iron Deficiency Anaemia or Iron Deficiency Anemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Hemoglobin (Hb) From Baseline to Week 8Primary· Baseline to week 8
Efficacy
Evaluate the effect on the hemoglobin (Hb) level following treatment with iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with iron deficiency anaemia (IDA) .
Response was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with IDA, when oral iron preparations were ineffective or could not be used or in whom the screening Hb measurement in Investigators' opinion were sufficiently low to require rapid repletion of iron stores.
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
2.49
2.41 – 2.56
Iron Sucrose
2.49
2.38 – 2.59
Incidence of Protocol-defined Serious or Severe Hypersensitivity ReactionsPrimary· Baseline to week 8
Safety
For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness.
The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinica
Safety
Results show the composite cardiovascular adverse events (AEs), that started on or after the first dose of randomised treatment (i.e. treatment emergent) up to week 8.
The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).
The potential cardiovascular AEs included the following:
* Death due to any cause
* Non-fatal myocardial infarction
* Non-fatal stroke
* Unstable angina requiring hospitalisation
* Congestive heart failure requiring hospitalisation or medical intervention
* Arrhythmias
* Hy
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
8
Iron Sucrose
6
Time to First Composite Cardiovascular Safety AESecondary· Baseline, week 1, 2, 4, and 8
Safety
Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the CEAC, were considered for this endpoint.
Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not re
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
NA
NA – NA
Iron Sucrose
NA
NA – NA
S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8Secondary· Baseline, week 1, 2, 4, and 8
Safety
Results show the number of subjects who had s-phosphate \<2 mg/dL at any time from baseline to week 1, 2, 4, or 8.
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
38
Iron Sucrose
11
Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8Secondary· Baseline, week 1, 2, 4, and 8
Efficacy
Results show responders to the treatment. A subject was considered a Hb responder to a certain week if an increase in Hb of at least 2 g/dL from baseline to the week in question was observed (week 1, 2, 4, and 8).
Responder YES week 1
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
51
Iron Sucrose
12
Responder YES week 2
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
297
Iron Sucrose
94
Responder YES week 4
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
514
Iron Sucrose
250
Responder YES week 8
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
606
Iron Sucrose
309
Time to Change in Hb Concentration ≥2 g/dLSecondary· Baseline, week 1, 2, 4, and 8
Efficacy
Time to change in Hb concentration ≥2 g/dL. Subjects who achieved Hb concentration increase of ≥2 g/dL (from baseline to week 1, 2, 4, or 8).
For responders, time to Hb response was defined as the scheduled time from baseline until the visit where the first Hb response was measured.
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
28
NA – NA
Iron Sucrose
28
28 – 56
Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8Secondary· Week 1 to week 8
Efficacy
Hb concentration of \>12 g/dL at any time from week 1 to week 8.
Results show the number of participants who achieved Hb concentration of \>12 g/dL at any time from week 1 to week 8.
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
484
Iron Sucrose
225
Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8Secondary· Week 1 to week 8
Efficacy
Results show the number of participants who achieved Hb concentration increase of ≥2 g/dL at any time from week 1 to week 8.
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
687
Iron Sucrose
340
S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8Secondary· Week 1 to week 8
Efficacy
Proportion of subjects reaching the composite endpoint of s-ferritin concentration ≥100 ng/mL and TSAT of 20-50% at any time from week 1 to 8.
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
680
Iron Sucrose
164
Change in Hb Concentration From Baseline to Week 1, 2, and 4Secondary· Baseline, week 1, 2, and 4
Efficacy
Change in Hb concentration from baseline to week 1, 2, and 4.
Week 1
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
0.70
± 0.85
Iron Sucrose
0.47
± 0.69
Week 2
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
1.49
± 1.13
Iron Sucrose
1.25
± 0.93
Week 4
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
2.15
± 1.27
Iron Sucrose
2.13
± 1.10
Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8Secondary· Baseline, week 1, 2, 4, and 8
Efficacy
Change in s-ferritin concentration from baseline to weeks 1, 2, 4, and 8.
Week 1
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
373.5
± 228.9
Iron Sucrose
105.7
± 79.1
Week 2
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
211.8
± 152.4
Iron Sucrose
169.9
± 129.8
Week 4
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
98.0
± 103.9
Iron Sucrose
109.2
± 108.7
Week 8
Group
Value
95% CI
Iron Isomaltoside/Ferric Derisomaltose
49.0
± 79.7
Iron Sucrose
58.7
± 104.8
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time a subjects had signed the informed consent form (CRF) and until they had completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 8 weeks (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 10-15 weeks (including a 14-day screening period and if necessary a run-in period)..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®) compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of Iron isomaltoside/ferric derisomaltose
Trials testing the same drug.
NCT03237065 — Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Su
· Phase 3
· completed
NCT03238911 — Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Su
· Phase 3
· completed
NCT02962648 — An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
· Phase 3
· completed
NCT02940860 — Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent
· Phase 3
· completed
Other recruiting trials for Iron Deficiency Anaemia
Currently open trials in the same condition.
NCT05990166 — Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
· Phase 2
· active not recruiting
Other Pharmacosmos A/S trials
Trials by the same sponsor.
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· Phase 3
· recruiting
NCT05545202 — A Randomized, Comparative, Double-blind Trial of Pentaisomaltose and Dimethyl Sulphoxide for Cryoprotection of Hematopoi
· Phase 4
· not yet recruiting
NCT05874401 — Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
· Phase 4
· recruiting
NCT05179226 — Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia
· Phase 3
· recruiting
NCT03466983 — A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxyma
· Phase 4
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pharmacosmos A/S
Last refreshed: 6 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02940886.