A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON

Phase 3 Terminated 667 enrolled Biogen

RandomizedSequentialTriple-blindTreatment

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.

Timeline

Start: 2019-05-29
Primary completion: 2023-08-08
Completion: 2023-08-08

Outcome

Missed primary endpoint

Stopped: “Discontinuation of all bardoxolone chronic kidney disease programs”

registry analysis (superiority test); Bardoxolone Methyl vs Placebo; p =0.3886; Least Square Means Difference 0.97 (95% CI -1.25 to 3.19); ANCOVA NCT03918447 ↗

Publications

St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bardoxolone methyl	Small molecule	20 mg	Oral
Subject	Bardoxolone methyl	Small molecule	30 mg	Oral