Bardoxolone, an investigational drug, significantly improved kidney function in patients with autosomal dominant polycystic kidney disease (ADPKD) or IgA nephropathy during a phase 2 trial, investigators reported at the European Renal Association-European Dialysis and Transplant Association 55th congress in Copenhagen, Denmark.
The ADPKD cohort of the open-label PHOENIX trial, which enrolled 31 patients, found that bardoxolone-treated patients demonstrated a significant mean improvement in estimated glomerular filtration rate (eGFR) of 6.6 mL/min/1.73 m2 at week 4, increasing to 12 mL/min/1.73 m2 at week 12. Patients had a mean eGFR at baseline of 47.7 mL/min/1.73 m2. according to a press release issued by Reata Pharmaceuticals, which is developing the drug.
In the IgA nephropathy cohort, which included 26 patients with a mean eGFR at baseline of 46.2 mL/min/1.73 m2, bardoxolone recipients had a mean improvement in eGFR of 8.4 mL/min/1.73 m2 at week 8.
No drug-related serious adverse events have been reported, and adverse events that have been reported generally have been mild to moderate.
PHOENIX investigator Pablo E. Pergola, MD, PhD, Research Director at Renal Associates, PA, in San Antonio, stated in the press release that the medication has resulted in large improvements in kidney function in 5 different forms of chronic kidney disease and a high percentage of patients from 11 trials. “These observations suggest that bardoxolone is addressing pathogenic pathways of inflammation and fibrosis that contribute to the loss of kidney function in patients with chronic kidney disease,” Dr Pergola said.
Presentation of the new findings follows the recent FDA approval of tolvaptan for use in adult patients with ADPKD.