Bardoxolone methyl increases eGFR rates compared with placebo
Click Here to Manage Email Alerts
The investigational drug, bardoxolone methyl preserved kidney function in patients and provided eGFR benefits for those with chronic kidney disease, according to an oral abstract presentation given as part of ASN Kidney Week.
Study author Laura H. Mariani, MD, a nephrologist and clinical researcher in the division of nephrology at the University of Michigan, presented data from the placebo-controlled set of 2,462 patients. Of these patients, 1,232 received placebo and 1,230 received bardoxolone methyl for between approximately 6 months and 2 years. Data were pooled from the CARDINAL phase 3 trial, TSUBAKI trial and BEACON trial.
"The integrated analysis of all of these trials shows that GFR is increased on treatment. Some of these trials have had patient exposures as long as 2 years and cover a diverse set of causes of CKD including not only diabetes, but also Alport's, diabetic kidney disease, focal segmental glomerulosclerosis, and immunoglobulin A nephropathy," Mariani said.
From between 16 and 100 weeks, the group that received bardoxolone methyl showed statistically significantly increased eGFR rates compared with the placebo group.
"After 4 weeks after drug withdrawal, that difference between the two groups was still statistically significant," Mariani said.
A similar pattern was seen in the overall integrated analysis set, she noted.
Importantly, she said, there is now a database of more than 3,000 patients who have participated in bardoxolone methyl trials.
The study authors noted that common adverse events in both integrated sets included muscle spasms, decreased appetite, hypomagnesaemia and decreased weight.
"Bardoxolone has an acceptable safety profile, and importantly, since the risk mitigation strategy was implemented, there have been no serious cardiac failure events reported with bardoxolone-treated patients who have CKD," Mariani said.
Collapse
Mariani LH, et al. Abstract FR-OR54. Presented at: ASN Kidney Week; Nov. 2-7, 2021 (virtual meeting).
Read more about
Click Here to Manage Email Alerts