Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Multi-Center, Open-Label, Randomized, Parallel Group, Dose-Ranging, Pharmacodynamic Phase II Trial to Determine the Effects of Bardoxolone Methyl (RTA 402, Amorphous Dispersion) on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease (eGFR 15-45 mL/Min/1.73m2)
This study assesses the effects of a new formulation of bardoxolone methyl on eGFR in Patients with Chronic Kidney Disease and Type 2 Diabetes.
Bardoxolone methyl (RTA 402) is an Antioxidant Inflammation Modulator (AIM) that is undergoing clinical testing in chronic kidney disease (CKD). Bardoxolone methyl and other AIMs inhibit immune-mediated inflammation by restoring redox homeostasis in inflamed tissues through the induction of 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. These stimuli cause further activation of NF-kB, promoting inflammation, mesangial cell contraction, mesangial expansion and endothelial dysfunction, the end result of which is decreased renal function. By inducing Nrf2 and suppressing redox-driven inflammation, we hypothesize that inflammation and resultant adverse renal functional changes in patients with chronic kidney disease resulting from diabetes can be suppressed. In a Phase IIa open label study of patients with CKD and type 2 diabetes, treatment with bardoxolone methyl for 28 days resulted in significant improvements in renal function, including increases in eGFR, and decreases in serum creatinine, cystatin C, BUN, phosphorus, uric acid, creatinine clearance, and angiotensin II; improvements in glycemic control as assessed by hemoglobin A1c; and improvements in markers of endothelial dysfunction and systemic inflammation, such as circulating endothelial cells and adiponectin. These data are consistent with the hypothesis that bardoxolone methyl improves renal function through suppression of renovascular oxidative stress and inflammation. A new formulation of bardoxolone methyl has been developed, which is the same chemical entity but manufactured to contain an amorphous dispersion rather than a crystalline solid state. The new amorphous dispersion formulation of bardoxolone methyl has been shown to be more orally bioavailable in non-human primates. The purpose of this study is to determine the appropriate dose of the new bardoxolone methyl formulation to use in future clinical studies by determining the dose response relationship on eGFR. Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen. ;
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