Results from two studies looking at the effects of an experimental drug (bardoxolone) on kidney function in patients with chronic kidney disease (CKD) have been released. One of the studies involved patients with Alport syndrome, and the second was with patients with autosomal dominant polycystic kidney disease (ADPKD). The original article can be found here, at Globe Newswire.
About the Drug Being Tested
Both studies evaluated the effects of bardoxolone (bardoxolone methyl). Bardoxolone is an oral drug that is thought to work by activating Nrf2, which is involved in processes that reduce inflammation through affecting mitochondrial function, decreasing oxidative stress, and inhibiting (reducing) pro-inflammatory signalling.
So far, bardoxolone has been granted Orphan status for the treatment of Alport syndrome by both the US FDA and European Commission. The FDA has also awarded the drug this status for the treatment of pulmonary arterial hypertension.
The ‘Cardinal’ Study
The Cardinal Phase 2/3 study evaluated the effects of bardoxolone as a treatment for patients with CKD linked to Alport syndrome.
Patients taking part in the Phase 2 part of the study who were treated with bardoxolone showed an increased estimated glomerular filtration rate (eGFR) after 48 weeks, compared to the baseline measurement. eGFR is used to measure kidney function, and a higher score indicates better kidney function. According to the researchers, patients’ kidney function had been decreasing each year before taking part in the study, and the improvement seen after one year of being treated with bardoxolone appeared to recover about two years of kidney function decline (as measured by eGFR). The improvement was also found to be maintained when the drug was withdrawn for four weeks after 48 weeks of treatment.
The ‘Phoenix’ Study
In the Phoenix Phase 2 study of patients with ADPKD, patients treated with bardoxolone showed a significant increase in eGFR after twelve weeks. Previously, historical data from 29 out of the 31 participants showed that their kidney function, as measured by eGFR, had previously been declining. No serious adverse events thought to be linked to the treatment occurred, although one patient discontinued the study after treatment-related fatigue.