BACKGROUND:Type 2 diabetes mellitus (T2DM) is the most important contributing cause of end-stage renal disease (ESRD) worldwide. Bardoxolone methyl, a nuclear factor-erythroid-2-related factor 2 activator, augments estimated glomerular filtration. The Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial was designed to establish whether bardoxolone methyl slows or prevents progression to ESRD. Herein, we describe baseline characteristics of the BEACON population. METHODS: BEACON is a randomized double-blind placebo-controlled clinical trial in 2185 patients with T2DM and chronic kidney disease stage 4 (eGFR between 15 and 30 mL/min/1.73 m(2)) designed to test the hypothesis that bardoxolone methyl added to guideline-recommended treatment including inhibitors of the renin-angiotensin-aldosterone system slows or prevents progression to ESRD or cardiovascular death compared with placebo. RESULTS: Baseline characteristics (mean or percentage) of the population include age 68.5 years, female 43%, Caucasian 78%, eGFR 22.5 mL/min/1.73 m(2) and systolic/diastolic blood pressure 140/70 mmHg. The median urinary albumin:creatinine ratio was 320 mg/g and the frequency of micro- and macroalbuminuria was 30 and 51%, respectively. Anemia, abnormalities in markers of bone metabolism and elevations in cardiovascular biomarkers were frequently observed. A history of cardiovascular disease was present in 56%, neuropathy in 47% and retinopathy in 41% of patients. CONCLUSIONS: The BEACON trial enrolled a population heretofore unstudied in an international randomized controlled trial. Enrolled patients suffered with numerous co-morbid conditions and exhibited multiple laboratory abnormalities, highlighting the critical need for new therapies to optimize management of these conditions.
RCT Entities:
BACKGROUND:Type 2 diabetes mellitus (T2DM) is the most important contributing cause of end-stage renal disease (ESRD) worldwide. Bardoxolone methyl, a nuclear factor-erythroid-2-related factor 2 activator, augments estimated glomerular filtration. The Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial was designed to establish whether bardoxolone methyl slows or prevents progression to ESRD. Herein, we describe baseline characteristics of the BEACON population. METHODS:BEACON is a randomized double-blind placebo-controlled clinical trial in 2185 patients with T2DM and chronic kidney disease stage 4 (eGFR between 15 and 30 mL/min/1.73 m(2)) designed to test the hypothesis that bardoxolone methyl added to guideline-recommended treatment including inhibitors of the renin-angiotensin-aldosterone system slows or prevents progression to ESRD or cardiovascular death compared with placebo. RESULTS: Baseline characteristics (mean or percentage) of the population include age 68.5 years, female 43%, Caucasian 78%, eGFR 22.5 mL/min/1.73 m(2) and systolic/diastolic blood pressure 140/70 mmHg. The median urinary albumin:creatinine ratio was 320 mg/g and the frequency of micro- and macroalbuminuria was 30 and 51%, respectively. Anemia, abnormalities in markers of bone metabolism and elevations in cardiovascular biomarkers were frequently observed. A history of cardiovascular disease was present in 56%, neuropathy in 47% and retinopathy in 41% of patients. CONCLUSIONS: The BEACON trial enrolled a population heretofore unstudied in an international randomized controlled trial. Enrolled patients suffered with numerous co-morbid conditions and exhibited multiple laboratory abnormalities, highlighting the critical need for new therapies to optimize management of these conditions.
Authors: Dick de Zeeuw; Tadao Akizawa; Paul Audhya; George L Bakris; Melanie Chin; Heidi Christ-Schmidt; Angie Goldsberry; Mark Houser; Melissa Krauth; Hiddo J Lambers Heerspink; John J McMurray; Colin J Meyer; Hans-Henrik Parving; Giuseppe Remuzzi; Robert D Toto; Nosratola D Vaziri; Christoph Wanner; Janet Wittes; Danielle Wrolstad; Glenn M Chertow Journal: N Engl J Med Date: 2013-11-09 Impact factor: 91.245
Authors: Melanie P Chin; George L Bakris; Geoffrey A Block; Glenn M Chertow; Angie Goldsberry; Lesley A Inker; Hiddo J L Heerspink; Megan O'Grady; Pablo E Pergola; Christoph Wanner; David G Warnock; Colin J Meyer Journal: Am J Nephrol Date: 2018-01-18 Impact factor: 3.754
Authors: Marguerite M Conley; Catherine M McFarlane; David W Johnson; Jaimon T Kelly; Katrina L Campbell; Helen L MacLaughlin Journal: Cochrane Database Syst Rev Date: 2021-03-30
Authors: Nienke M A Idzerda; Bergur V Stefansson; Michelle J Pena; David C Sjostrom; David C Wheeler; Hiddo J L Heerspink Journal: Nephrol Dial Transplant Date: 2020-09-01 Impact factor: 5.992