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NCT03918447 · ClinicalTrials.gov registry record · Phase 3
A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 667
- Enrollment target
NCT03918447: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT03918447 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 667 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03918447, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 667 participants
- Enrollment target
Study Summary
This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 850 patients will be enrolled.
Primary Outcome
Estimated Glomerular filtration rate (eGFR) is a measure of kidney function assessed through blood/serum. eGFR was measured in milliliters per minute per 1.73 meters square (mL/min/1.73 m\^2). Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function. Negative change from baseline in eGFR indicates worsened kidney function.
Interventions
- DRUG Placebo oral capsule
- DRUG Bardoxolone methyl oral capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 667 participants |
| Start Date | 2019-05-29 |
| Est. Completion | 2023-08-08 |
| Phase | Phase 3 |
Why NCT03918447 stopped before completion
NCT03918447 is an interventional study that assigns participants to a tested intervention. The registered 667 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 (14% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03918447 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03918447 about?
NCT03918447 is a clinical study titled "A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON". This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 850 patients will be enrolled.
What is the current status of trial NCT03918447?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 667 participants. The study started on 2019-05-29. Estimated completion is 2023-08-08.
What interventions are being tested in trial NCT03918447?
The interventions under investigation include: Placebo oral capsule (DRUG), Bardoxolone methyl oral capsule (DRUG).
Who is sponsoring clinical trial NCT03918447?
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 NCT03918447's enrollment target sits among peer trials
667 551st of 2000 higher than 1,450 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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