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NCT03263091 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden
A Phase 3 study, sponsored by Kyntra Bio.
- Terminated
- Registry status
- Phase 3
- Development phase
- 184
- Enrollment target
NCT03263091: Clinical Trial Phase 3 study, sponsored by Kyntra Bio.
NCT03263091 is a Phase 3 study that was terminated before completion, run by Kyntra Bio. The registered enrollment target is 184 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03263091, a Phase 3 study, was terminated before completion, sponsored by Kyntra Bio.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 184 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in participants with lower risk MDS and low red blood cell transfusion burden.
Primary Outcome
The RBC TI was defined as the absence of any intravenous (IV) RBC transfusion (packed cell or whole blood) during any consecutive 56 days during the treatment period. Data presented is for number of participants with RBC TI ≥8 weeks (≥56 consecutive days) since first dose in the first 28 weeks of treatment.
Interventions
- DRUG Placebo
- DRUG Roxadustat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2018-01-29 |
| Est. Completion | 2023-06-20 |
| Phase | Phase 3 |
Why NCT03263091 stopped before completion
NCT03263091 is an interventional study that assigns participants to a tested intervention. The registered 184 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 (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03263091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03263091 about?
NCT03263091 is a clinical study titled "Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden". The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in participants with lower risk MDS and low red blood cell transfusion burden.
What is the current status of trial NCT03263091?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 184 participants. The study started on 2018-01-29. Estimated completion is 2023-06-20.
What interventions are being tested in trial NCT03263091?
The interventions under investigation include: Placebo (DRUG), Roxadustat (DRUG).
Who is sponsoring clinical trial NCT03263091?
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 NCT03263091's enrollment target sits among peer trials
184 1418th of 2000 higher than 581 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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