PMID- 24169612
OWN - NLM
STAT- MEDLINE
DCOM- 20141028
LR  - 20210716
IS  - 1460-2385 (Electronic)
IS  - 0931-0509 (Linking)
VI  - 28
IP  - 11
DP  - 2013 Nov
TI  - 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.
PG  - 2841-50
LID - 10.1093/ndt/gft445 [doi]
AB  - 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.
FAU - Lambers Heerspink, Hiddo J
AU  - Lambers Heerspink HJ
AD  - Department of Clinical Pharmacology, University of Groningen, University Medical 
      Center Groningen, Groningen, The Netherlands.
FAU - Chertow, Glenn M
AU  - Chertow GM
FAU - Akizawa, Tadao
AU  - Akizawa T
FAU - Audhya, Paul
AU  - Audhya P
FAU - Bakris, George L
AU  - Bakris GL
FAU - Goldsberry, Angie
AU  - Goldsberry A
FAU - Krauth, Melissa
AU  - Krauth M
FAU - Linde, Peter
AU  - Linde P
FAU - McMurray, John J
AU  - McMurray JJ
FAU - Meyer, Colin J
AU  - Meyer CJ
FAU - Parving, Hans-Henrik
AU  - Parving HH
FAU - Remuzzi, Giuseppe
AU  - Remuzzi G
FAU - Christ-Schmidt, Heidi
AU  - Christ-Schmidt H
FAU - Toto, Robert D
AU  - Toto RD
FAU - Vaziri, Nosratola D
AU  - Vaziri ND
FAU - Wanner, Christoph
AU  - Wanner C
FAU - Wittes, Janet
AU  - Wittes J
FAU - Wrolstad, Danielle
AU  - Wrolstad D
FAU - de Zeeuw, Dick
AU  - de Zeeuw D
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - England
TA  - Nephrol Dial Transplant
JT  - Nephrology, dialysis, transplantation : official publication of the European 
      Dialysis and Transplant Association - European Renal Association
JID - 8706402
RN  - 0 (Biomarkers)
RN  - 6SMK8R7TGJ (Oleanolic Acid)
RN  - CEG1Q6OGU1 (bardoxolone methyl)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Biomarkers/analysis
MH  - Cardiovascular Diseases/*drug therapy/etiology
MH  - Diabetes Mellitus, Type 2/*complications
MH  - Diabetic Nephropathies/*drug therapy/etiology
MH  - Double-Blind Method
MH  - Female
MH  - Glomerular Filtration Rate
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Oleanolic Acid/*analogs & derivatives/therapeutic use
MH  - Prognosis
MH  - Renal Insufficiency, Chronic/*drug therapy/etiology
MH  - Young Adult
OTO - NOTNLM
OT  - BEACON
OT  - Bardoxolone
OT  - RCT
OT  - diabetic nephropathy
EDAT- 2013/10/31 06:00
MHDA- 2014/10/29 06:00
CRDT- 2013/10/31 06:00
PHST- 2013/10/31 06:00 [entrez]
PHST- 2013/10/31 06:00 [pubmed]
PHST- 2014/10/29 06:00 [medline]
AID - gft445 [pii]
AID - 10.1093/ndt/gft445 [doi]
PST - ppublish
SO  - Nephrol Dial Transplant. 2013 Nov;28(11):2841-50. doi: 10.1093/ndt/gft445.