Rationale and Trial Design of Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: The Occurrence of Renal Events (BEACON)
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- 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.…
Autor(en): | 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 |
Dokumentart: | Artikel / Aufsatz in einer Zeitschrift |
Institute der Universität: | Medizinische Fakultät / Medizinische Klinik und Poliklinik I |
Sprache der Veröffentlichung: | Englisch |
Titel des übergeordneten Werkes / der Zeitschrift (Englisch): | American Journal of Nephrology |
ISSN: | 0250-8095 |
ISSN: | 1421-9670 |
Erscheinungsjahr: | 2013 |
Band / Jahrgang: | 37 |
Heft / Ausgabe: | 3 |
Seitenangabe: | 212-222 |
Originalveröffentlichung / Quelle: | 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 |
Allgemeine fachliche Zuordnung (DDC-Klassifikation): | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
Freie Schlagwort(e): | Nrf2; bardoxolone methyl; cardiovascular death; chronic kidney disease; clinical trial; diabetes mellitus; end-stage renal disease; glomerular filtration rate; trial design |
Datum der Freischaltung: | 17.08.2021 |
Datum der Erstveröffentlichung: | 28.02.2013 |
Anmerkungen: | 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. |
Lizenz (Deutsch): | Deutsches Urheberrecht |