Rationale and Trial Design of Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: The Occurrence of Renal Events (BEACON)

Autor: Paul Audhya, Hans-Henrick Parving, Colin J. Meyer, Janet Wittes, Christoph Wanner, Rajiv Agarwal, G. Remuzzi, Pablo E. Pergola, Tadao Akizawa, Glenn M. Chertow, Hiddo J.L. Heerspink, David G. Warnock, Nosratola D. Vaziri, Melissa Krauth, George L. Bakris, Dick de Zeeuw, Melanie P. Chin, Robert D. Toto, John J.V. McMurray
Přispěvatelé: Groningen Kidney Center (GKC), Methods in Medicines evaluation & Outcomes research (M2O)
Rok vydání: 2013
Předmět:
medicine.medical_specialty
NEPHROPATHY
Anti-Inflammatory Agents
Renal function
Type 2 diabetes
urologic and male genital diseases
bardoxolone methyl
End stage renal disease
Nephropathy
Diabetes mellitus
INFLAMMATION
Double-Blind Method
Internal medicine
CKD
medicine
Humans
COHORT
Diabetic Nephropathies
ddc:610
Bardoxolone methyl
Oleanolic Acid
Renal Insufficiency
Chronic
nrf2
Intensive care medicine
RISK
OUTCOMES
end-stage renal disease
business.industry
MORTALITY
Type 2 Diabetes Mellitus
RANDOMIZED CONTROLLED-TRIAL
medicine.disease
cardiovascular death
RAMIPRIL
Clinical trial
Treatment Outcome
Diabetes Mellitus
Type 2
Nephrology
Early Termination of Clinical Trials
trial design
Clinical Trials Data Monitoring Committees
business
INTERVENTION
chronic kidney disease
Glomerular Filtration Rate
Kidney disease
Zdroj: American Journal of Nephrology, 37(3), 212-222. KARGER
ISSN: 1421-9670
0250-8095
Popis: 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.
Databáze: OpenAIRE
Externí odkaz: