Adults 18 to 70, any sex, with Chronic Kidney Diseases. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12Primary· Baseline through 12 weeks after participant receives the first dose
To assess the change in eGFR from baseline to week 12. eGFR is a measure of kidney function assessed through blood/serum. Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function.
Group
Value
95% CI
Bardoxolone Methyl
6.79
± 0.925
Placebo
-0.92
± 0.868
Adverse events — posted to ClinicalTrials.gov
Time frame: 17 weeks.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Bardoxolone Methyl
Serious: 3/39 (8%)
Deaths: 0/39
Placebo
Serious: 1/42 (2%)
Deaths: 0/42
Serious adverse events (4 terms)
Reaction
System
Bardoxolone Methyl
Placebo
Gastrooesophageal reflux disease
Gastrointestinal disorders
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
Biliary dyskinesia
Hepatobiliary disorders
—
—
Acute kidney injury
Renal and urinary disorders
—
—
Other adverse events (119 terms — click to expand)
This multi-center, randomized, double-blind, placebo-controlled, Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with CKD due to multiple etiologies at risk of rapid disease progression. Approximately 70 patients will be enrolled and randomized 1:1 to either bardoxolone methyl or placebo. Patients with CKD secondary to varying etiologies will be enrolled from age 18-70 years with eGFR ≥ 20 to \< 60 mL/min/1.73 m2, and other risk factors for rapid progression of kidney disease.
The maximum target dose will be determined by baseline proteinuria status. Patients with baseline urine albumin to creatinine ratio (UACR) ≤ 300 mg/g will be titrated to a maximum dose of 20 mg, and patients with baseline UACR \> 300 mg/g will be titrated to a maximum dose of 30 mg. Qualified patients will be randomized 1:1 to receive either bardoxolone methyl or placebo once daily (preferably in the morning) throughout a 12-week dosing period.
Patients in the study will follow the same visit and assessment schedule. Patients will be assessed during treatment at Day 1, Weeks 1, 2, 4, 6, 8, and 12 and by telephone contact on Days 3, 10, 21, 31, 35, and 45. Date of last dose and the end-of-treatment assessments mark the end of the treatment period. Patients will not receive study drug during a 5-week off-treatment period between Weeks 12 and 17. The off-treatment (OT) period includes 5 visits requiring various assessments to characterize eGFR from the time of study drug discontinuation through Day 35 off-treatment.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03918447 — A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
· Phase 3
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biogen
Last refreshed: 3 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04702997.