Phase 3
N=511
IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose
Iron Deficiency Anaemia
Bottom Line
View on ClinicalTrials.gov: NCT02130063 ↗Enrolled (actual)
511
Serious AEs
3.4%
Results posted
May 2018
Primary outcome: Primary: Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5 — 226; 83 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- iron isomaltoside 1000 (Monofer®) (Drug); iron sucrose (Venofer®) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pharmacosmos A/S
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5 |
226; 83 | — |
| SECONDARY Change in Hb Concentration |
1.56; 0.87; 2.35; 1.74; 2.52; 2.05 | — |
| SECONDARY Change in Serum (s)-Ferritin Concentration |
431.2; 86.9; 516.6; 126.2; 285.3; 195.0 | — |
| SECONDARY Change in Transferrin Saturation (TSAT) |
15.7; 3.3; 17.9; 5.7; 16.3; 11.5 | — |
Summary
The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.
Eligibility Criteria
Inclusion Criteria
- Men or women > 18 years having IDA caused by different aetiologies such as abnormal uterine bleeding, gastrointestinal diseases, cancer, bariatric procedures (gastric bypass operations), and other conditions leading to significant blood loss and with a documented history of intolerance or unresponsiveness to oral iron therapy for at least one month prior to study enrollment or where there at investigators judgment is a clinical need to deliver iron rapidly
- Hb 3 times upper limit of normal)
- Active acute or chronic infections (assessed by clinical judgement supplied with white blood cells (WBC) and C-reactive protein (CRP))
- Body weight < 50 kg
- Rheumatoid arthritis with symptoms or signs of active inflammation
- Pregnant or nursing women. In order to avoid pregnancy, women have to be surgically sterile or use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product
- History of multiple allergies
- Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
- Erythropoietin treatment within 8 weeks prior to the screening visit
- Other iron treatment or blood transfusion within 4 weeks prior to the screening visit
- Planned elective surgery during the study
- Participation in any other clinical study within 3 months prior to the screening
- Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischaemic heart disease, or uncontrolled diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT02130063). 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.