CARDINAL Clinical Trial
CARDINAL is a Phase 2/3 clinical trial evaluating the safety and effectiveness of bardoxolone methyl (an oral
investigational drug) for the treatment of Alport syndrome.
There are two cohorts within CARDINAL. In the phase 2 cohort, approximately 30 patients will be enrolled and
will receive bardoxolone methyl. In the phase 3 cohort, up to 180 patients will be enrolled, and these patients
will be randomly assigned (like by the flip of a coin) to either bardoxolone methyl or placebo (an inactive capsule).
The group of patients assigned to bardoxolone will be compared to the patients assigned to placebo, in
order to help researchers better understand how patients are responding to the study drug.
All participants will follow the same visit schedule and will be asked to complete the same study procedures.
Participation in CARDINAL may last up to 2 years, and will include 16 study visits and 6 scheduled phone calls.
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 Alport syndrome.