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NCT03019185 · ClinicalTrials.gov registry record · Phase 2
A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 187
- Enrollment target
NCT03019185: Completed Phase 2 study, sponsored by Biogen.
NCT03019185 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 187 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03019185, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 187 participants
- Enrollment target
Study Summary
This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.
Primary Outcome
To assess the change in eGFR from baseline to week 12 (Phase 2). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Interventions
- DRUG Placebo Oral Capsule
- DRUG Bardoxolone Methyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2017-03-02 |
| Est. Completion | 2020-10-30 |
| Phase | Phase 2 |
What the finished NCT03019185 record still lists
NCT03019185 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Capsule is the first listed.
NCT03019185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03019185 about?
NCT03019185 is a clinical study titled "A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL". This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blin...
What is the current status of trial NCT03019185?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2017-03-02. Estimated completion is 2020-10-30.
What interventions are being tested in trial NCT03019185?
The interventions under investigation include: Placebo Oral Capsule (DRUG), Bardoxolone Methyl (DRUG).
Who is sponsoring clinical trial NCT03019185?
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 NCT03019185's enrollment target sits among peer trials
187 357th of 2000 higher than 1,644 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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