New results from the Phase 2/3 CARDINAL trial continue to support the benefits of bardoxolone methyl in improving kidney function in people with chronic kidney disease (CKD) due to Alport syndrome.
Data from a new analysis of the trial’s Phase 2 part show that significant improvements to the kidneys — previously seen in an interim analysis after 12 weeks of treatment — are maintained through week 36 (8.2 months).
Researchers measured the estimated glomerular filtration rate (eGFR) to assess patients’ kidney function.
Phase 2 of CARDINAL (NCT03019185) is a dose-escalating study in 30 people with confirmed Alport syndrome and symptoms of kidney disease.
Improvement in eGFR measured at week 36 was statistically significant when compared to levels at the study’s start (baseline), registering a mean of 11.3 mL/min/1.73 m2. Most importantly, the improvement showed no statistical significant differences from that of week 12.
“Bardoxolone continues to be well-tolerated in Alport syndrome patients as evidenced by the encouraging safety profile and high patient retention rate in the Phase 2 cohort of CARDINAL,” Colin Meyer, chief medical officer of Reata, said in a press release.
“These data demonstrate that the clinically meaningful increases in kidney function we observed in Alport syndrome patients after 12 weeks of treatment are durable for at least 36 weeks and consistent with our observations from prior trials of bardoxolone in other forms of CKD,” he added.
Bardoxolone methyl is an investigative therapy being developed by Reata Pharmaceuticals to treat chronic kidney disease (CKD) caused by Alport syndrome, and other kidney illnesses.
The investigative therapy works by reducing inflammation and restoring mitochondrial activity, leading to improvements in renal function.
The CARDINAL trial — which in total will recruit more than 200 patients, ages 12 to 60, at sites in the U.S., Canada, Europe, Australia and Japan — will continue to assess eGFR values at week 48, 52, 64, 76, 88, 100, and 104. Patients will undergo a four-week withdrawal period (no therapy administered) between weeks 48 and 52. Treatment will re-start at week 52, with patients getting the same dose they received previously through week 100. Enrollment information is available here or by clicking on the trial’s identification number.
At week 104, four weeks after the end of treatment participants will undergo a final evaluation.
Side effects reported at week 36 were generally mild to moderate, with no serious therapy-related adverse events.
“We appreciate the interest and commitment of the Alport syndrome patient community and CARDINAL investigators to advance our understanding of bardoxolone in these patients with unmet need,” Meyer said.