Bardoxolone methyl in type 2 diabetes and stage 4 chronic kidney disease.

ABSTRACT:

Background

Although inhibitors of the renin-angiotensin-aldosterone system can slow the progression of diabetic kidney disease, the residual risk is high. Whether nuclear 1 factor (erythroid-derived 2)-related factor 2 activators further reduce this risk is unknown.

Methods

We randomly assigned 2185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease (estimated glomerular filtration rate [GFR], 15 to <30 ml per minute per 1.73 m(2) of body-surface area) to bardoxolone methyl, at a daily dose of 20 mg, or placebo. The primary composite outcome was end-stage renal disease (ESRD) or death from cardiovascular causes.

Results

The sponsor and the steering committee terminated the trial on the recommendation of the independent data and safety monitoring

SUBMITTER: de Zeeuw D 

PROVIDER: S-EPMC4496027 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature