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Iron Supplement

Iron isomaltoside/ferric derisomaltose for Iron-Deficiency Anemia

Phase 3
Waitlist Available
Research Sponsored by Pharmacosmos A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®) compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.

Eligible Conditions
  • Iron-Deficiency Anemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Hemoglobin (Hb) From Baseline to Week 8
Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
Secondary study objectives
Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8
Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8
Change in Hb Concentration From Baseline to Week 1, 2, and 4
+15 more

Side effects data

From 2018 Phase 3 trial • 122 Patients • NCT03237065
25%
Hypophosphatemia
14%
Blood phosphorus decreased
11%
Nausea
9%
Blood parathyroid hormone increased
7%
Headache
5%
Vomiting
5%
Serum ferritin increased
2%
Vitamin D deficiency
2%
Dehydration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ferric Carboxymaltose
Iron Isomaltoside/Ferric Derisomaltose

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Iron isomaltoside/ferric derisomaltoseExperimental Treatment1 Intervention
Administered IV
Group II: Iron sucroseActive Control1 Intervention
Administered IV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferrous cation
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Pharmacosmos A/SLead Sponsor
44 Previous Clinical Trials
8,190 Total Patients Enrolled
Pharmacosmos A/S Clinical and Non-clinical ResearchStudy DirectorPharmacosmos A/S
5 Previous Clinical Trials
2,087 Total Patients Enrolled
~168 spots leftby Dec 2025
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