FALCON Study: Bardoxolone Methyl in Patients with ADPKD

At the NKF virtual 2021 Spring Clinical Meetings, Arlene Chapman, MD, and colleagues described the trial design for FALCON, a phase 3 study to examine the safety, tolerability, and efficacy of bardoxolone methyl (Bard) on the rate of decline in estimated glomerular filtration rate (eGFR) in patients with autosomal dominant polycystic kidney disease (ADPKD). The study design was presented during a virtual poster session in a poster titled Trial Design for Phase 3 FALCON: Evaluation of the Safety, Tolerability, and Efficacy of Bardoxolone Methyl in Patients with Autosome Dominant Polycystic Kidney Disease (ADPKD).

Bard is an Nrf2 activator. In previous trials among more than 3000 patients with various forms of kidney disease, Bard improved measured GFR and eGFR. Results of a phase 2 study demonstrated that Bard increased mean eGFR by 9.3 mL/min/1.73 m² in patients with ADPKD after 12 weeks of treatment.

FALCON (NCT03918447) is a phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled trial that will enroll 300 participants with ADPKD. Eligible participants will be 18 to 70 years of age, eGFR ≥30 to ≤90 mL/min/1.73 m², and urine albumin-to-creatinine ratio ≤2500 mg/g. Exclusion criteria include concomitant use of tolvaptan and elevated brain natriuretic peptide (BNP) or clinically significant cardiac disease.

The primary efficacy end point of interest will be change in eGFR from baseline in participants treated with Bard relative to placebo at week 52 following a 4-week drug withdrawal period. Safety monitoring will include daily weight, and frequent assessments of BNP and kidney pain. Participants will continue treatment until week 1 and will be followed for an additional 4 weeks off the study drug

In summary, the researchers said, “FALCON is a phase 3 randomized, placebo-controlled study that will assess the safety, tolerability, and efficacy of Bard on change in kidney function (eGFR) in subjects with ADPKD.”

Source: Chapman A, Appel G B, Block G A, et al. Trial design for phase FALCON: Evaluation of the safety, tolerability, and efficacy of bardoxolone methyl in patients with autosomal dominant polycystic kidney disease (ADPKD). Abstract of a poster presented at the National Kidney Foundation virtual 2021 Spring Clinical Meetings (Abstract #304), April 9, 2021.