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.
The primary objectives of this study is assess the off-treatment change from baseline in estimated glomerular filtration rate (eGFR) at Week 52 or following a 4-week drug treatment withdrawal period in the first year of treatment and to assess safety and tolerability.
- Diagnoses of ADPKD by cyst count,
- Estimated glomerular filtration rate between 30 to 90 mL/min/1.73 m2 (18-55 years old) and 30-44 mL/min/1.73 m2 (56-70 years old),
- Systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at Screen A visit (patients on a blood pressure stabilizing medication must be on a stable dose for at least 6 weeks prior to Screen A)
- Uncontrolled hypertension
- Currently taking Tolvaptan
- Patient is immunocompromised
Length of participation is 104 weeks. There is a 4-week period off of study drug between Week 48 and Week 52. There is a blood draw and urine sample done at every study visit. Patients record their weight every day with a scale provided by the study sponsor. There is an echocardiogram at the Screen A visit.