Phase 3
Completed N=1,512
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)
Iron Deficiency Anaemia · Iron Deficiency Anemia
Source: ClinicalTrials.gov NCT02940886 ↗
Enrolled (actual)
1,512
Serious AEs
2.3%
Results posted
Mar 2020
Primary outcomePrimary: Change in Hemoglobin (Hb) From Baseline to Week 8 — 2.49; 2.49 g/dL
◆ Published Evidence
Highly cited
104citations · ~15 / year
A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial.
Summary
Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®) compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.
Linked Publications
-
A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin (Hb) From Baseline to Week 8 |
2.49; 2.49 | — |
| PRIMARY Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions |
3; 2 | — |
| SECONDARY Composite Cardiovascular Adverse Events (AEs) |
8; 6 | 0.5695 |
| SECONDARY Time to First Composite Cardiovascular Safety AE |
NA; NA | 0.3913 |
| SECONDARY S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8 |
38; 11 | — |
| SECONDARY Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8 |
51; 12; 297; 94; 514; 250 | 0.0077 sig |
| SECONDARY Time to Change in Hb Concentration ≥2 g/dL |
28; 28 | 0.0880 |
| SECONDARY Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8 |
484; 225 | 0.2420 |
| SECONDARY Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8 |
687; 340 | 0.8746 |
| SECONDARY S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8 |
680; 164 | <0.0001 sig |
| SECONDARY Change in Hb Concentration From Baseline to Week 1, 2, and 4 |
0.70; 0.47; 1.49; 1.25; 2.15; 2.13 | <0.0001 sig |
| SECONDARY Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8 |
373.5; 105.7; 211.8; 169.9; 98.0; 109.2 | <0.0001 sig |
| SECONDARY Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8 |
16.68; 5.84; 12.33; 10.58; 11.63; 11.08 | <0.0001 sig |
| SECONDARY Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8 |
63.2; 22.4; 38.8; 37.0; 31.2; 35.1 | <0.0001 sig |
| SECONDARY Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8 |
7.98; 7.38; 10.74; 11.89; 14.08; 15.36 | 0.0422 sig |
| SECONDARY Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking |
5.0; 5.0; 0.0; 0.0 | — |
| SECONDARY Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car |
15.0; 15.0 | — |
| SECONDARY Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit |
2.0; 2.0; 2.0; 2.0 | — |
| SECONDARY Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits |
529; 258; 233; 113; 211; 111 | — |
| SECONDARY Health Care Resource Use Questionnaire |
1.08; 1.00; 3.38; 3.00 | — |
Eligibility Criteria
Inclusion criteria includes:
- Men or women ≥ 18 years
- Subjects having IDA caused by different etiologies
- Subjects with intolerance to oral iron therapy or a need for rapid repletion of iron stores:
- Haemoglobin (Hb) ≤ 11 g/dL
- Transferrin Saturation (TSAT) 3 times upper limit of normal
- Required dialysis for treatment of chronic kidney disease (CKD)
- Alcohol or drug abuse within the past 6 months
- Pregnant or nursing women
Data sourced from ClinicalTrials.gov (NCT02940886) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.