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Bardoxolone methyl improved kidney function in patients with type 2 diabetes
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ASN Renal Week 2010
An investigational treatment for chronic kidney disease appears to reduce the stage of disease and improve estimated glomerular filtration rate and other measures of kidney function in patients with diabetes, according to phase 2b study results.
“These encouraging results suggest that bardoxolone methyl has the potential to change the treatment landscape of CKD and offer new hope for these patients and their families,” Pablo Pergola, MD, PhD, clinical associate professor of medicine at the University of Texas Health Science Center at San Antonio and research director for Renal Associates PA, said in a press release.
Approximately 60% of the patients who were assigned to bardoxolone methyl experienced a reduction in the classification of the severity of their disease after 24 weeks of treatment; only 17% of patients in the placebo group experienced such a reduction. In addition, 13% of patients in the placebo group experienced a worsening of CKD stage vs. 4% in the bardoxolone methyl group.
The multicenter, double blind clinical trial included 227 patients with CKD and type 2 diabetes who were randomly assigned to once-daily placebo or bardoxolone methyl in doses of 25 mg, 75 mg or 150 mg.
At 24 weeks, patients assigned to bardoxolone methyl experienced a mean increase in estimated glomerular filtration rate (GFR) — the primary endpoint — of 10 mL/min/1.72m2 vs. no change in the placebo group. Approximately three-quarters of bardoxolone methyl-treated patients experienced an improvement in estimated GFR of 10% or more, including one-quarter who improved by 50% or more, compared with less than 2% of placebo-treated patients (P<.001).
Significant reductions were also observed in other markers of kidney function, including uric acid, serum phosphorus and blood urea nitrogen.
Safety data revealed a higher frequency of mild to moderate adverse events in the bardoxolone methyl group, with muscle spasm the most frequently reported.
Bardoxolone methyl is an antioxidant inflammation modulator that activates Nrf2, thereby inducing the transcription of genes that decrease the level of oxidative stress and suppress important inflammatory mediators, according to the press release.
Reata Pharmaceuticals and Abbott anticipate initiation of a phase 3 study in the first half of 2011.
For more information:
- Pergola PE. LB-FC2. Presented at: Renal Week 2010; Nov. 16-21, 2010; Denver.
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