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NCT02130063 · ClinicalTrials.gov registry record · Phase 3
IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose
A Phase 3 study, sponsored by Pharmacosmos A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 511
- Enrollment target
NCT02130063: Completed Phase 3 study, sponsored by Pharmacosmos A/S.
NCT02130063 is a Phase 3 study that has completed, run by Pharmacosmos A/S. The registered enrollment target is 511 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02130063, a Phase 3 study, has completed, sponsored by Pharmacosmos A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 511 participants
- Enrollment target
Study 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.
Primary Outcome
The primary efficacy endpoint of the trial was the count of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5. 'Any time' implied that if the endpoint was met at a time-point prior to or at week 5, the effect (increase of ≥ 2 g/dL) did not have to be maintained throughout the trial in order for a subject to be a responder. Number of responders (i.e. a subject with increase in Hb ≥ 2 g/dL from baseline at any time from week 1 to week 5) and percentages acco
Interventions
- DRUG iron isomaltoside 1000 (Monofer®)
- DRUG iron sucrose (Venofer®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
What the finished NCT02130063 record still lists
NCT02130063 is an interventional study that assigns participants to a tested intervention. The registered 511 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 2 interventions - of which iron isomaltoside 1000 (Monofer®) is the first listed.
NCT02130063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02130063 about?
NCT02130063 is a clinical study titled "IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose". 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.
What is the current status of trial NCT02130063?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2014-05. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02130063?
The interventions under investigation include: iron isomaltoside 1000 (Monofer®) (DRUG), iron sucrose (Venofer®) (DRUG).
Who is sponsoring clinical trial NCT02130063?
This trial is sponsored by Pharmacosmos A/S, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02130063's enrollment target sits among peer trials
511 728th of 2000 higher than 1,272 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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