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NCT01147666 · ClinicalTrials.gov registry record · Phase 2
Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis
A Phase 2 study, sponsored by Kyntra Bio.
- Completed
- Registry status
- Phase 2
- Development phase
- 161
- Enrollment target
NCT01147666: Completed Phase 2 study, sponsored by Kyntra Bio.
NCT01147666 is a Phase 2 study that has completed, run by Kyntra Bio. The registered enrollment target is 161 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01147666, a Phase 2 study, has completed, sponsored by Kyntra Bio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 161 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy and safety of roxadustat in participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, previously treated with intravenous (IV) epoetin alfa.
Primary Outcome
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. Last observation carried forward (LOCF) method was used to impute missing values.
Interventions
- OTHER Placebo
- DRUG Epoetin Alfa
- DRUG Roxadustat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2010-05-17 |
| Est. Completion | 2012-10-15 |
| Phase | Phase 2 |
What the finished NCT01147666 record still lists
NCT01147666 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01147666 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01147666 about?
NCT01147666 is a clinical study titled "Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis". The primary objective of this study is to evaluate the efficacy and safety of roxadustat in participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, previously treated with intravenous (IV) epoetin alfa.
What is the current status of trial NCT01147666?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 161 participants. The study started on 2010-05-17. Estimated completion is 2012-10-15.
What interventions are being tested in trial NCT01147666?
The interventions under investigation include: Placebo (OTHER), Epoetin Alfa (DRUG), Roxadustat (DRUG).
Who is sponsoring clinical trial NCT01147666?
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 NCT01147666's enrollment target sits among peer trials
161 422nd of 2000 higher than 1,579 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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