Trials / Terminated
TerminatedNCT03749447
An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 270 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bardoxolone methyl | Bardoxolone methyl capsules |
Timeline
- Start date
- 2019-03-08
- Primary completion
- 2023-08-23
- Completion
- 2023-08-23
- First posted
- 2018-11-21
- Last updated
- 2025-06-03
- Results posted
- 2024-03-19
Locations
87 sites across 6 countries: United States, Australia, France, Japan, Puerto Rico, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03749447. Inclusion in this directory is not an endorsement.