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NCT01414075 · ClinicalTrials.gov registry record · Phase 2
Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment
A Phase 2 study, sponsored by Kyntra Bio.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT01414075: Completed Phase 2 study, sponsored by Kyntra Bio.
NCT01414075 is a Phase 2 study that has completed, run by Kyntra Bio. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01414075, a Phase 2 study, has completed, sponsored by Kyntra Bio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.
Primary Outcome
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation.
Interventions
- DRUG Roxadustat
- DRUG Oral Iron
- DRUG IV Iron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-07-21 |
| Est. Completion | 2013-01-10 |
| Phase | Phase 2 |
What the finished NCT01414075 record still lists
NCT01414075 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which Roxadustat is the first listed.
NCT01414075 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01414075 about?
NCT01414075 is a clinical study titled "Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment". The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.
What is the current status of trial NCT01414075?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2011-07-21. Estimated completion is 2013-01-10.
What interventions are being tested in trial NCT01414075?
The interventions under investigation include: Roxadustat (DRUG), Oral Iron (DRUG), IV Iron (DRUG).
Who is sponsoring clinical trial NCT01414075?
This trial is sponsored by Kyntra Bio, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01414075's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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