A Phase 3 Study of Bardoxolone Methyl in Patients With Diabetic Kidney Disease; AYAME Study
Status:
Active, not recruiting
Trial end date:
2024-05-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to demonstrate the efficacy of multiple oral doses of RTA 402
(5, 10, or 15 mg) administered once daily in patients with diabetic kidney disease (DKD)
using the time to onset of a ≥ 30% decrease in estimated glomerular filtration rate
calculated from serum creatinine (eGFR) from baseline or end-stage renal disease (ESRD) as an
indicator in a randomized, double-blind, placebo-controlled study; the safety of RTA 402 will
also be evaluated.