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NCT04484857 · ClinicalTrials.gov registry record · Phase 3
Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
A Phase 3 study, sponsored by Kyntra Bio.
- Completed
- Registry status
- Phase 3
- Development phase
- 283
- Enrollment target
NCT04484857: Completed Phase 3 study, sponsored by Kyntra Bio.
NCT04484857 is a Phase 3 study that has completed, run by Kyntra Bio. The registered enrollment target is 283 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04484857, a Phase 3 study, has completed, sponsored by Kyntra Bio.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 283 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and effectiveness of roxadustat dosing regimens among hemodialysis participants converted from erythropoiesis stimulating agent (ESA) therapy or who are ESA-naïve.
Primary Outcome
Percentage of participants with mean Hb value ≥10 g/dL, averaged from Week 16 through Week 24 has been reported. Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. 95% confidence interval (CI) was calculated based on the normal approximation to the binomial distribution.
Interventions
- DRUG Roxadustat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2020-07-22 |
| Est. Completion | 2021-09-17 |
| Phase | Phase 3 |
What the finished NCT04484857 record still lists
NCT04484857 is an interventional study that assigns participants to a tested intervention. The registered 283 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 (63% lower).
The record links to 0 conditions, and to 1 intervention - of which Roxadustat is the first listed.
NCT04484857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04484857 about?
NCT04484857 is a clinical study titled "Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants". The purpose of this study is to assess the safety and effectiveness of roxadustat dosing regimens among hemodialysis participants converted from erythropoiesis stimulating agent (ESA) therapy or who are ESA-naïve.
What is the current status of trial NCT04484857?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 283 participants. The study started on 2020-07-22. Estimated completion is 2021-09-17.
What interventions are being tested in trial NCT04484857?
The interventions under investigation include: Roxadustat (DRUG).
Who is sponsoring clinical trial NCT04484857?
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 NCT04484857's enrollment target sits among peer trials
283 1194th of 2000 higher than 807 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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