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Rationale and Trial Design of Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: The Occurrence of Renal Events (BEACON)
Please always quote using this URN: urn:nbn:de:bvb:20-opus-196832
- 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 diabetesBackground: 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.…
Author: | Dick de Zeeuw, Tadao Akizawa, Rajiv Agarwal, Paul Audhya, George L. Bakris, Melanie Chin, Melissa Krauth, Hiddo J. Lambers Heerspink, Colin J. Meyer, John J. McMurray, Hans-Henrik Parving, Pablo E. Pergola, Giuseppe Remuzzi, Robert D. Toto, Nosratola D. Vaziri, Christoph Wanner, David G. Warnock, Janet Wittes, Glenn M. Chertow |
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URN: | urn:nbn:de:bvb:20-opus-196832 |
Document Type: | Journal article |
Faculties: | Medizinische Fakultät / Medizinische Klinik und Poliklinik I |
Language: | English |
Parent Title (English): | American Journal of Nephrology |
ISSN: | 0250-8095 |
ISSN: | 1421-9670 |
Year of Completion: | 2013 |
Volume: | 37 |
Issue: | 3 |
Pagenumber: | 212-222 |
Source: | American Journal of Nephrology 2013; 37(3):212–222. DOI: 10.1159/000346948 |
DOI: | https://doi.org/10.1159/000346948 |
Pubmed Id: | https://pubmed.ncbi.nlm.nih.gov/23467003 |
Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
Tag: | Nrf2; bardoxolone methyl; cardiovascular death; chronic kidney disease; clinical trial; diabetes mellitus; end-stage renal disease; glomerular filtration rate; trial design |
Release Date: | 2021/08/17 |
Date of first Publication: | 2013/02/28 |
Note: | 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. |
Licence (German): | Deutsches Urheberrecht |