This study assesses the effects of bardoxolone methyl (RTA 402) in patients with type 2 diabetes and chronic kidney disease.
Bardoxolone methyl (RTA 402) is an Antioxidant Inflammation Modulator (AIM) that is undergoing clinical testing in chronic kidney disease (CKD) and cancer. Bardoxolone methyl and other AIMs inhibit immune-mediated inflammation by restoring redox homeostasis in inflamed tissues by inducing the cytoprotective transcription factor Nrf2. In the diabetic population, adipocytes produce cytokines and mobilize free fatty acids which induce insulin resistance. Resultant hyperglycemia and increased cytokine production induces reactive oxygen and nitrogen species which in turn induce vascular inflammation and endothelial dysfunction. This process causes further activation of NF-kB, creating a vicious cycle of inflammation, vasoconstriction, and ischemia, the end result of which is sclerosis in the kidney and coronary arteries. By inducing Nrf2 and suppressing redox-driven inflammation, we hypothesize that this cycle of inflammation and sclerosis can be abrogated. Based on Phase IIa data, we hypothesize that bardoxolone methyl will improve renal function through suppression of renal oxidative stress, inflammation and improvement of glomerular filtration. This study was previously posted by Reata Pharmaceuticals. In September 2023, sponsorship of the trial was transferred to Biogen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
227
Placebo
Oral, Once Daily
To determine the change in eGFR from baseline in patients with type 2 diabetes and CKD (baseline eGFR = 20 - 45 mL/min/1.73m2) after receiving bardoxolone methyl for 6 months (24 weeks) following randomization
Time frame: 6 months (24 weeks)
To determine the safety and tolerability of bardoxolone methyl when administered for 12 months (52 weeks)following randomization to type 2 diabetic patients with CKD (eGFR 20 - 45 mL/min/1.73m2).
Time frame: 1 year (52 weeks)
To quantify the effects of bardoxolone methyl at two different dosing levels relative to placebo on: Hemoglobin A1c, Serum Creatinine, Urine, Intact PTH albumin/creatinine ratio, Serum Phosphorus, Blood Urea Nitrogen, Uric Acid
Time frame: 6 months (24 weeks) and 1 year (52 weeks)
To determine the change in eGFR from baseline in patients with type 2 diabetes and CKD (baseline eGFR = 20 - 45 mL/min/1.73m2) after receiving bardoxolone methyl for 12 months (52 weeks) following randomization.
Time frame: 12 months (52 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Montgomery, Alabama, United States
Unnamed facility
Chula Vista, California, United States
Unnamed facility
La Mesa, California, United States
Unnamed facility
Mission Viejo, California, United States
Unnamed facility
Orange, California, United States
Unnamed facility
Riverside, California, United States
Unnamed facility
San Dimas, California, United States
Unnamed facility
Middlebury, Connecticut, United States
Unnamed facility
Washington D.C., District of Columbia, United States
...and 32 more locations