A research team from Showa University in Tokyo presented results of a phase 3 clinical trial of a drug containing methyl bardoxolone at ASN Kidney Week 2023, which has been shown to be effective in slowing the progression of chronic kidney disease in patients with diabetes.
The AYAME study included more than a thousand patients with diabetic nephropathy who did not have risk factors for heart failure. Over more than three years of monitoring, methyl bardoxolone has been shown to effectively inhibit the deterioration of renal function and delay the onset of chronic renal failure, as confirmed by measurements of glomerular filtration rate.
This drug works through activation of the Keap1-Nrf2 signaling pathway, which plays a protective role in kidney cells, protecting them from oxidative stress caused by reactive oxygen species. This is significant since oxidative stress is one of the key factors in the development and progression of kidney damage in diabetes.
Importantly, there was no increase in cardiovascular events such as heart attacks, strokes or heart failure during the trial, demonstrating the cardiac safety of the drug. This differs from the results of a previous study, which observed an increase in the incidence of heart failure among patients receiving treatment.
These findings open up new prospects for the treatment of chronic renal failure, which is a serious complication of diabetes mellitus and requires complex treatment and maintenance regimen, including diet and drug therapy.