CARDINAL is an international, Phase 2/3 trial examining the safety, tolerability, and efficacy of bardoxolone methyl in patients with Alport syndrome.
Due to the rarity of the disease, each nephrologist may only see a limited number of patients with Alport syndrome. Your referral is crucial to the success of CARDINAL. Every patient counts. Your referral can make a difference. The study team’s involvement with your patients would be exclusively study-speciﬁc. If genetic testing is needed to conﬁrm Alport syndrome, the cost will be covered by Reata. Eligible participants may receive compensation and/or reimbursement for study-related time and travel, including ﬂight or lodging costs.
Bardoxolone methyl is an experimental, oral, once-daily antioxidant inflammation modulator that activates molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. Bardoxolone methyl activates Nrf2, a transcription factor that promotes normal mitochondrial function, increases production of antioxidant and detoxification enzymes, reduces oxidative stress, and reduces pro-inflammatory signaling.
Bardoxolone methyl has been studied in multiple clinical trials, including seven CKD studies enrolling approximately 2,600 patients with type 2 diabetes. Improvements in renal function, including inulin clearance, creatinine clearance, and eGFR, have been observed in clinical studies with bardoxolone methyl treatment in diabetic CKD patients, but it has not been studied previously in patients with Alport syndrome.
Bardoxolone methyl has generally been well-tolerated in most patient populations studied to date. In one previous study, a small subset of Stage 4 CKD patients with type 2 diabetes demonstrated a risk for developing fluid overload adverse events. These patients were subsequently determined to have defined risk factors, including a medical history of heart failure and an elevated BNP level, indicating the presence of fluid retention prior to the study. The increased risk of fluid overload has not been observed in subsequent studies in patients with diabetic CKD or pulmonary hypertension that excluded at-risk patients and carefully monitored their fluid status.
Bardoxolone methyl’s mechanism of action targets inflammatory mechanisms that promote loss of kidney function in Alport syndrome patients, which ultimately leads to the need for dialysis or kidney transplant. Data from studies in CKD patients suggest that bardoxolone methyl could produce a durable increase in kidney function. If a similar effect is observed in Alport patients, this could ultimately prevent or delay end-stage renal disease.
CARDINAL Study Design
Please consider referring your patients with Alport syndrome to a CARDINAL research center by sharing this site (CARDINALclinicaltrial.com) or by submitting an Inquiry Form. A member of the CARDINAL study team will contact you within 48 hours.