Type 2 Diabetes Clinical Trial
Official title:
A 52-Week, Multi-center, Double-blind, Randomized, Placebo-controlled Phase IIb Trial to Determine the Effects of Bardoxolone Methyl (RTA 402) on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease With an eGFR of 20 - 45 mL/Min/1.73m2
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 Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen. ;
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