Phase 2b study of bardoxolone methyl for the treatment of chronic kidney disease (CKD)
Reata Pharmaceuticals and Abbott announced data from their Phase 2b study which suggests that bardoxolone methyl, an investigational treatment for chronic kidney disease (CKD), may reduce the stage of CKD and improve estimated glomerular filtration rate (eGFR) and other measures of kidney function in the majority of patients receiving the drug. This multi-center, randomized, double-blind clinical trial enrolled 227 CKD patients with type 2 diabetes who were randomized to receive once-daily doses of placebo or 25, 75 or 150mg doses of bardoxolone methyl. The primary endpoint of the study was change in estimated GFR following 24 weeks of treatment.
At week 24, patients treated with bardoxolone methyl experienced a mean increase in estimated GFR of over 10 mL/min/1.72m2, compared with no change in the placebo group. Approximately three-quarters of bardoxolone methyl-treated patients experienced an improvement in eGFR of 10% or more, including one-quarter who saw an improvement of 50% or more compared to less than 2% of patients on placebo. (p<0.001).
Bardoxolone methyl is an antioxidant inflammation modulator (AIM) that activates Nrf2, thereby inducing the transcription of genes that decrease the level of oxidative stress and suppress important inflammatory mediators.
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