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 |
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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 |
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