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NCT01630889 · ClinicalTrials.gov registry record · Phase 2
Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease
A Phase 2 study, sponsored by Kyntra Bio.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT01630889: Completed Phase 2 study, sponsored by Kyntra Bio.
NCT01630889 is a Phase 2 study that has completed, run by Kyntra Bio. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01630889, a Phase 2 study, has completed, sponsored by Kyntra Bio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this open-label extension study is to evaluate long-term efficacy and safety of roxadustat in maintaining hemoglobin (Hb) in participants with dialysis and non-dialysis chronic kidney disease (CKD) who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study.
Primary Outcome
Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting. The specific duration over which the participants were assessed was identified as "over time" for the endpoint in the study protocol. Therefore, to be consistent with the endpoint in the study protocol, an individual timepoint was not identi
Interventions
- DRUG Roxadustat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2012-05-18 |
| Est. Completion | 2019-12-12 |
| Phase | Phase 2 |
What the finished NCT01630889 record still lists
NCT01630889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Roxadustat is the first listed.
NCT01630889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01630889 about?
NCT01630889 is a clinical study titled "Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease". The purpose of this open-label extension study is to evaluate long-term efficacy and safety of roxadustat in maintaining hemoglobin (Hb) in participants with dialysis and non-dialysis chronic kidney disease (CKD) who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study...
What is the current status of trial NCT01630889?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2012-05-18. Estimated completion is 2019-12-12.
What interventions are being tested in trial NCT01630889?
The interventions under investigation include: Roxadustat (DRUG).
Who is sponsoring clinical trial NCT01630889?
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 NCT01630889's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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