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The DOI matches its Crossref record; 10 of the 10 references it cites were found in a registry or an index.

Bardoxolone Methyl in Type 2 Diabetes and Stage 4 Chronic Kidney Disease

Open access
de Zeeuw, Dick, Akizawa, Tadao, Audhya, Paul, Bakris, George L., Chin, Melanie, Christ-Schmidt, Heidi, Goldsberry, Angie, Houser, Mark, Krauth, Melissa, Lambers Heerspink, Hiddo J., McMurray, John J., Meyer, Colin J., Parving, Hans-Henrik, Remuzzi, Giuseppe, Toto, Robert D., Vaziri, Nosratola D., Wanner, Christoph, Wittes, Janet, Wrolstad, Danielle, Chertow, Glenn M.·2013·New England Journal of Medicine
DOI 10.1056/nejmoa1306033
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Abstract

BACKGROUND: Although inhibitors of the renin-angiotensin-aldosterone system can slow the progression of diabetic kidney disease, the residual risk is high. Whether nuclear 1 factor (erythroid-derived 2)-related factor 2 activators further reduce this risk is unknown. METHODS: We randomly assigned 2185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease (estimated glomerular filtration rate [GFR], 15 to <30 ml per minute per 1.73 m(2) of body-surface area) to bardoxolone methyl, at a daily dose of 20 mg, or placebo. The primary composite outcome was end-stage renal disease (ESRD) or death from cardiovascular causes. RESULTS: The sponsor and the steering committee terminated the trial on the recommendation of the independent data and safety monitoring committee; the median follow-up was 9 months. A total of 69 of 1088 patients (6%) randomly assigned to bardoxolone methyl and 69 of 1097 (6%) randomly assigned to placebo had a primary composite outcome (hazard ratio in the bardoxolone methyl group vs. the placebo group, 0.98; 95% confidence interval [CI], 0.70 to 1.37; P=0.92). In the bardoxolone methyl group, ESRD developed in 43 patients, and 27 patients died from cardiovascular causes; in the placebo group, ESRD developed in 51 patients, and 19 patients died from cardiovascular causes. A total of 96 patients in the bardoxolone methyl group were hospitalized for heart failure or died from heart failure, as compared with 55 in the placebo group (hazard ratio, 1.83; 95% CI, 1.32 to 2.55; P<0.001). Estimated GFR, blood pressure, and the urinary albumin-to-creatinine ratio increased significantly and body weight decreased significantly in the bardoxolone methyl group, as compared with the placebo group. CONCLUSIONS: Among patients with type 2 diabetes mellitus and stage 4 chronic kidney disease, bardoxolone methyl did not reduce the risk of ESRD or death from cardiovascular causes. A higher rate of cardiovascular events with bardoxolone methyl than with placebo prompted termination of the trial. (Funded by Reata Pharmaceuticals; BEACON ClinicalTrials.gov number, NCT01351675.).

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Metadata

Authors
de Zeeuw, D., Akizawa, T., Audhya, P., Bakris, G. L., Chin, M., Christ-Schmidt, H., Goldsberry, A., Houser, M., Krauth, M., Lambers Heerspink, H. J., McMurray, J. J., Meyer, C. J., Parving, H.-H., Remuzzi, G., Toto, R. D., Vaziri, N. D., Wanner, C., Wittes, J., Wrolstad, D., & Chertow, G. M.
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2013-12-26
Volume
369
Issue
26
Pages
2492-2503
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa1306033
OpenAlex
W2112948259
Cited by
1,030
References
10
FWCI
55.91
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Bardoxolone Methyl in Type 2 Diabetes and Stage 4 Chronic Kidney Disease. https://app.cochat.ai/papers/10.1056/nejmoa1306033
The paper
de Zeeuw, D., Akizawa, T., Audhya, P., Bakris, G. L., Chin, M., Christ-Schmidt, H., Goldsberry, A., Houser, M., Krauth, M., Lambers Heerspink, H. J., McMurray, J. J., Meyer, C. J., Parving, H.-H., Remuzzi, G., Toto, R. D., Vaziri, N. D., Wanner, C., Wittes, J., Wrolstad, D., & Chertow, G. M. (2013). Bardoxolone Methyl in Type 2 Diabetes and Stage 4 Chronic Kidney Disease. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1306033

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.