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NCT00761657 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis
A Phase 2 study, sponsored by Kyntra Bio.
- Completed
- Registry status
- Phase 2
- Development phase
- 117
- Enrollment target
NCT00761657: Completed Phase 2 study, sponsored by Kyntra Bio.
NCT00761657 is a Phase 2 study that has completed, run by Kyntra Bio. The registered enrollment target is 117 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00761657, a Phase 2 study, has completed, sponsored by Kyntra Bio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 117 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the safety, tolerability, and pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week (BIW) or 3 times a week (TIW) for up to 4 weeks to participants with chronic kidney disease (CKD) not requiring dialysis.
Primary Outcome
An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs defined as an AE beginning after first dose of study drug until 28 days after last dose of study drug or existing AEs that worsened after first dose of study drug until the participant's last study visit. Severe AEs defined as incapacitating, inability to perform usual activities. Drug-related TEAEs defined as TEAEs with possible, probable, or d
Interventions
- DRUG Placebo
- DRUG Roxadustat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2006-11-01 |
| Est. Completion | 2010-06-21 |
| Phase | Phase 2 |
What the finished NCT00761657 record still lists
NCT00761657 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00761657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00761657 about?
NCT00761657 is a clinical study titled "Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis". The primary objective of the study is to evaluate the safety, tolerability, and pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week (BIW) or 3 times a week (TIW) for up to 4 weeks to participants with chronic kidney disease (CKD) not requiring dialysis.
What is the current status of trial NCT00761657?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 117 participants. The study started on 2006-11-01. Estimated completion is 2010-06-21.
What interventions are being tested in trial NCT00761657?
The interventions under investigation include: Placebo (DRUG), Roxadustat (DRUG).
Who is sponsoring clinical trial NCT00761657?
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 NCT00761657's enrollment target sits among peer trials
117 623rd of 2000 higher than 1,378 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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