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NCT02052310 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants
A Phase 3 study, sponsored by Kyntra Bio.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,043
- Enrollment target
NCT02052310: Completed Phase 3 study, sponsored by Kyntra Bio.
NCT02052310 is a Phase 3 study that has completed, run by Kyntra Bio. The registered enrollment target is 1,043 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02052310, a Phase 3 study, has completed, sponsored by Kyntra Bio.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,043 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD.
Primary Outcome
Hb values under the influence of rescue therapy were not censored for the primary analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (erythropoiesis-stimulating agent \[ESA\]) or red blood cell (RBC) transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missi
Interventions
- DRUG Epoetin Alfa
- DRUG Roxadustat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,043 participants |
| Start Date | 2014-02-11 |
| Est. Completion | 2018-09-21 |
| Phase | Phase 3 |
What the finished NCT02052310 record still lists
NCT02052310 is an interventional study that assigns participants to a tested intervention. Its 1,043 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 2 interventions - of which Epoetin Alfa is the first listed.
NCT02052310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02052310 about?
NCT02052310 is a clinical study titled "Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants". The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD.
What is the current status of trial NCT02052310?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,043 participants. The study started on 2014-02-11. Estimated completion is 2018-09-21.
What interventions are being tested in trial NCT02052310?
The interventions under investigation include: Epoetin Alfa (DRUG), Roxadustat (DRUG).
Who is sponsoring clinical trial NCT02052310?
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 NCT02052310's enrollment target sits among peer trials
1,043 284th of 2000 higher than 1,717 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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