TY  - JOUR
A1  - de Zeeuw, Dick
A1  - Akizawa, Tadao
A1  - Agarwal, Rajiv
A1  - Audhya, Paul
A1  - Bakris, George L.
A1  - Chin, Melanie
A1  - Krauth, Melissa
A1  - Lambers Heerspink, Hiddo J.
A1  - Meyer, Colin J.
A1  - McMurray, John J.
A1  - Parving, Hans-Henrik
A1  - Pergola, Pablo E.
A1  - Remuzzi, Giuseppe
A1  - Toto, Robert D.
A1  - Vaziri, Nosratola D.
A1  - Wanner, Christoph
A1  - Warnock, David G.
A1  - Wittes, Janet
A1  - Chertow, Glenn M.
T1  - Rationale and Trial Design of Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: The Occurrence of Renal Events (BEACON)
JF  - American Journal of Nephrology
N2  - 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.
KW  - clinical trial
KW  - diabetes mellitus
KW  - glomerular filtration rate
KW  - trial design
KW  - bardoxolone methyl
KW  - Nrf2
KW  - end-stage renal disease
KW  - cardiovascular death
KW  - chronic kidney disease
Y1  - 2013
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-196832
SN  - 0250-8095
SN  - 1421-9670
N1  - This publication is with permission of the rights owner freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively.
VL  - 37
IS  - 3
ER  - 
TY  - JOUR
A1  - Perkovic, Vlado
A1  - Agarwal, Rajiv
A1  - Fioretto, Paola
A1  - Hemmelgarn, Brenda R.
A1  - Levin, Adeera
A1  - Thomas, Merlin C.
A1  - Wanner, Christoph
A1  - Kasiske, Bertram L.
A1  - Wheeler, David C.
A1  - Groop, Per-Henrik
T1  - Management of patients with diabetes and CKD: conclusions from a "Kidney Disease: Improving Global Outcomes" (KDIGO) controversies conference
JF  - Kidney International
N2  - The prevalence of diabetes around the world has reached epidemic proportions and is projected to increase to 642 million people by 2040. Diabetes is already the leading cause of end-stage kidney disease (ESKD) in most developed countries, and the growth in the number of people with ESKD around the world parallels the increase in diabetes. The presence of kidney disease is associated with a markedly elevated risk of cardiovascular disease and death in people with diabetes. Several new therapies and novel investigational agents targeting chronic kidney disease patients with diabetes are now under development. This conference was convened to assess our current state of knowledge regarding optimal glycemic control, current antidiabetic agents and their safety, and new therapies being developed to improve kidney function and cardiovascular outcomes for this vulnerable population.
KW  - stage renal-disease
KW  - converting enzyme-inhibition
KW  - dietary sodium restriction
KW  - intensive glucose control
KW  - albumin excretion rate
KW  - blood pressure
KW  - cardiovascular outcomes
KW  - randomized trial
KW  - glycemic control
KW  - receptor
KW  - antidiabetic agents
KW  - cardiovascular disease
KW  - chronic kidney disease
KW  - diabetes
KW  - renoprotection
KW  - antagonist
Y1  - 2016
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-186599
VL  - 90
IS  - 6
ER  -