Before participating in CATALYST, patients must complete the screening process at one of the study centers. Eligible patients will receive either BARD capsules or placebo capsules and will be instructed to take the capsules once daily for 24 weeks. The study team will follow patients closely and will conduct visits through the duration of participation. The investigational drug, study-related procedures, and doctor visits will be provided at no cost to you. You may receive compensation for your time and travel.

The chart below shows the different stages of study participation.

CATALYST

Phases of Participation

SCREENING
Up to 90 days prior to randomization
  • Meet the study team
  • Review detailed information about the study with your doctor
  • Review medical history
  • Physical Exam
  • Electrocardiogram
  • Blood draws
  • 6 Minute Walk Test
  • Pulmonary Function Tests (PFTs)
  • Other assessments
RANDOMIZATION
Day 1
  • Begin daily dosing of bardoxolone methyl or placebo
  • Receive study materials
  • Physical Exam
  • Blood draws
  • 6 Minutes Walk Test
  • Other assessments
TREATMENT
Day 1 through Week 24
  • Daily dosing of bardoxolone methyl or Placebo
  • Record diary information daily
  • Use activity monitor
  • Visits to doctor's office
  • Telephone calls
  • Physical Exam
  • Electrocardiogram
  • Blood draws
  • 6 Minute Walk Test
  • PFTs
  • Other assessments
COMPLETION
Week 28
  • Final study visit
  • Physical Exam
  • Electrocardiogram
  • Blood draws
  • 6 Minutes Walk Test
  • PFTs
  • Other assessments

Study Participation is complete at approximately week 28.

Reata plans to provide bardoxolone methyl (active drug), through an extension study or program, to all patients who complete CATALYST. At the discretion of your doctor, you may participate in the extension study or program, until the drug is commercially available or the study/program is stopped.