NCT03918447

A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON

A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 667 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Patients will be randomized 1:1 to either bardoxolone methyl or placebo. Patients receiving bardoxolone methyl will start with once-daily dosing at 5 mg and will dose-escalate to 10 mg at Week 2, to 20 mg at Week 4, and then to 30 mg at Week 6 (only if baseline ACR \>300 mg/g) unless contraindicated clinically and approved by the medical monitor. Dose de-escalation is permitted during the study if indicated clinically, and subsequent dose re-escalation is also permitted to meet the dosing objective of the highest tolerated dose. All patients in the study will follow the same visit and assessment schedule. Patients will continue to receive study drug or placebo through Week 100 and will not receive study drug or placebo during a 12-week off-treatment period between Weeks 100 and 112.

Conditions

• Autosomal Dominant Polycystic Kidney
• ADPKD

Interventions

Type	Name	Description
DRUG	Bardoxolone methyl oral capsule	Bardoxolone methyl capsules dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status.
DRUG	Placebo oral capsule	Capsule containing an inert placebo

Timeline

• Start date: 2019-05-29
• Primary completion: 2023-08-08
• Completion: 2023-08-08
• First posted: 2019-04-17
• Last updated: 2025-06-03
• Results posted: 2024-06-11

Locations

137 sites across 10 countries: United States, Australia, Belgium, Czechia, France, Germany, Italy, Japan, Spain, United Kingdom

Regulatory

• FDA-regulated drug study