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Rationale and Trial Design of Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: The Occurrence of Renal Events (BEACON)de Zeeuw D.a · Akizawa T.b · Agarwal R.c · Audhya P.d · Bakris G.L.e · Chin M.d · Krauth M.d · Lambers Heerspink H.J.a · Meyer C.J.d · McMurray J.J.f · Parving H.-H.g · Pergola P.E.h · Remuzzi G.i · Toto R.D.j · Vaziri N.D.k · Wanner C.l · Warnock D.G.m · Wittes J.n · Chertow G.M.o
aDepartment of Clinical Pharmacology, University of Groningen, University Medical Center, Groningen, The Netherlands; bDivision of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan; cDepartment of Medicine, Indiana University School of Medicine and Richard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Ind., dREATA Pharmaceuticals, Irving, Tex., and eDepartment of Medicine, AHS Comprehensive Hypertension Center, The University of Chicago Medicine, Chicago, Ill., USA; fBHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK; gDepartment of Medical Endocrinology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; hRenal Associates, PA, San Antonio, Tex., USA; iUnit of Nephrology, Azienda Ospedaliera Ospedali Riuniti di Bergamo and Mario Negri Institute for Pharmacological Research, Bergamo, Italy; jDepartment of Medicine, University of Texas Southwestern Medical Center, Dallas, Tex., and kDivision of Nephrology and Hypertension, Department of Medicine, University of California, Irvine, Calif., USA; lDivision of Nephrology, Department of Medicine, University of Würzburg, Würzburg, Germany; mDepartment of Medicine, University of Alabama at Birmingham, Birmingham, Ala., nStatistics Collaborative, Inc., Washington, D.C., and oDepartment of Medicine, Stanford University School of Medicine, Palo Alto, Calif., USA
Background: Chronic kidney disease (CKD) associated with type 2 diabetes mellitus constitutes a global epidemic complicated by considerable renal and cardiovascular morbidity and mortality, despite the provision of inhibitors of the renin-angiotensin-aldosterone system (RAAS). Bardoxolone methyl, a synthetic triterpenoid that reduces oxidative stress and inflammation through Nrf2 activation and inhibition of NF-κB was previously shown to increase estimated glomerular filtration rate (eGFR) in patients with CKD associated with type 2 diabetes mellitus. To date, no antioxidant or anti-inflammatory therapy has proved successful at slowing the progression of CKD. Methods: Herein, we describe the design of Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: the Occurrence of Renal Events (BEACON) trial, a multinational, multicenter, double-blind, randomized, placebo-controlled Phase 3 trial designed to determine whether long-term administration of bardoxolone methyl (on a background of standard therapy, including RAAS inhibitors) safely reduces renal and cardiac morbidity and mortality. Results: The primary composite endpoint is time-to-first occurrence of either end-stage renal disease or cardiovascular death. Secondary endpoints include the change in eGFR and time to occurrence of cardiovascular events. Conclusion: BEACON will be the first event-driven trial to evaluate the effect of an oral antioxidant and anti-inflammatory drug in advanced CKD.
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