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NCT03749447 · ClinicalTrials.gov registry record · Phase 3
An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 270
- Enrollment target
NCT03749447: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT03749447 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 270 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03749447, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 270 participants
- Enrollment target
Study Summary
This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the study until bardoxolone methyl is available through commercial channels or until patient withdrawal, whichever is sooner.
Primary Outcome
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medicall
Interventions
- DRUG Bardoxolone methyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2019-03-08 |
| Est. Completion | 2023-08-23 |
| Phase | Phase 3 |
Why NCT03749447 stopped before completion
NCT03749447 is an interventional study that assigns participants to a tested intervention. The registered 270 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 (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Bardoxolone methyl is the first listed.
NCT03749447 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03749447 about?
NCT03749447 is a clinical study titled "An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)". This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the study until bardoxolon...
What is the current status of trial NCT03749447?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2019-03-08. Estimated completion is 2023-08-23.
What interventions are being tested in trial NCT03749447?
The interventions under investigation include: Bardoxolone methyl (DRUG).
Who is sponsoring clinical trial NCT03749447?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03749447's enrollment target sits among peer trials
270 1217th of 2000 higher than 781 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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