FALCON Clinical Study
FALCON is a Phase 3 clinical study evaluating the effectiveness and safety of bardoxolone methyl (an oral investigational drug) in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Approximately 300 patients, at 75 study centers, will be enrolled in FALCON around the world.
Before participating in FALCON, patients must complete two screening visits at one of the study centers. Eligible patients will receive either bardoxolone methyl or placebo (an inactive capsule). Patients will be randomly assigned (like by the flip of a coin) to either bardoxolone methyl or placebo. The group of patients assigned to bardoxolone methyl will be compared to the group of patients assigned to placebo in order to help researchers better understand the effects of bardoxolone methyl. The study team will follow all patients closely throughout study participation.
All participants will follow the same visit schedule and will be asked to complete the same study procedures. Participation in FALCON is planned to last up to 2 years and will include about 20 study visits and 6 scheduled phone calls.
FALCON Study Duration
|SCREENING||TREATMENT||WITHDRAWAL||TREATMENT||END OF STUDY|
|< 6 Months||< Week 1 - Week 4 >||Week 48 - Week 52
Off Study Treatment
|< Week 52 - Week 100 >||Week 104|
The investigational drug, study-related procedures, and doctor visits will be provided at no cost. If you travel to the site for your study visits, travel expenses will be reimbursed, and compensation for study-related time may be provided.
The design of this study is intended to provide the shortest path possible to generating data that will answer the important questions researchers are asking. The data can then expedite Reata’s ability to seek input from the FDA regarding the use of bardoxolone methyl in ADPKD.
FALCON at a Glance
Extended Access Program – Patients who complete FALCON may be eligible to receive the investigational drug, bardoxolone methyl, until such time as it can be made commercially available or the study is stopped.