title: Baseline characteristics in the Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial.
abstract: 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.affiliation: Department of Clinical Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Hiddo J
authors.initials: HJ
authors.lastname: Lambers Heerspink
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Chertow
authors.forename: Tadao
authors.initials: T
authors.lastname: Akizawa
authors.forename: Paul
authors.initials: P
authors.lastname: Audhya
authors.forename: George L
authors.initials: GL
authors.lastname: Bakris
authors.forename: Angie
authors.initials: A
authors.lastname: Goldsberry
authors.forename: Melissa
authors.initials: M
authors.lastname: Krauth
authors.forename: Peter
authors.initials: P
authors.lastname: Linde
authors.forename: John J
authors.initials: JJ
authors.lastname: McMurray
authors.forename: Colin J
authors.initials: CJ
authors.lastname: Meyer
authors.forename: Hans-Henrik
authors.initials: HH
authors.lastname: Parving
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Remuzzi
authors.forename: Heidi
authors.initials: H
authors.lastname: Christ-Schmidt
authors.forename: Robert D
authors.initials: RD
authors.lastname: Toto
authors.forename: Nosratola D
authors.initials: ND
authors.lastname: Vaziri
authors.forename: Christoph
authors.initials: C
authors.lastname: Wanner
authors.forename: Janet
authors.initials: J
authors.lastname: Wittes
authors.forename: Danielle
authors.initials: D
authors.lastname: Wrolstad
authors.forename: Dick
authors.initials: D
authors.lastname: de Zeeuw
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000032:analysis; D002318:Cardiovascular Diseases / Q000188:drug therapy* / Q000209:etiology; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D003928:Diabetic Nephropathies / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D008297:Male; D008875:Middle Aged; D009828:Oleanolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011379:Prognosis; D051436:Renal Insufficiency, Chronic / Q000188:drug therapy* / Q000209:etiology; D055815:Young Adult
chemical_list: D015415:Biomarkers; D009828:Oleanolic Acid; C445068:bardoxolone methyl
keywords: BEACON; Bardoxolone; RCT; diabetic nephropathy