Effects of Bardoxolone Methyl in Alport Syndrome.

ABSTRACT:

Background and objectives

Alport syndrome is an inherited disease characterized by progressive loss of kidney function. We aimed to evaluate the safety and efficacy of bardoxolone methyl in patients with Alport syndrome.

Design, setting, participants, & measurements

We randomly assigned patients with Alport syndrome, ages 12-70 years and eGFR 30-90 ml/min per 1.73 m², to bardoxolone methyl (n=77) or placebo (n=80). Primary efficacy end points were change from baseline in eGFR at weeks 48 and 100. Key secondary efficacy end points were change from baseline in eGFR at weeks 52 and 104, after an intended 4 weeks off treatment. Safety was assessed by monitoring for adverse events and change from baseline in vital signs, 12-lead electrocardiograms, labora

SUBMITTER: Warady BA 

PROVIDER: S-EPMC9718021 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature