Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes

Summary

This study assesses the efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease (ESRD) and cardiovascular deaths in patients with Stage 4 Chronic Kidney Disease (CKD) and type 2 diabetes receiving standard of care.

Timeline

Start

2011-06-30

Primary completion

2012-10-31

Completion

2012-12-31

Outcome

Missed primary endpoint

Stopped: “IDMC recommendation for safety concerns”

paper 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 PMID 24206459 ↗

paper bardoxolone methyl did not reduce the risk of ESRD or death from cardiovascular causes. PMID 24206459 ↗

Publications

• Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
• Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.
• de Zeeuw D, Akizawa T, Audhya P, Bakris GL, Chin M, Christ-Schmidt H, Goldsberry A, Houser M, Krauth M, Lambers Heerspink HJ, McMurray JJ, Meyer CJ, Parving HH, Remuzzi G, Toto RD, Vaziri ND, Wanner C, Wittes J, Wrolstad D, Chertow GM; BEACON Trial Investigators. Bardoxolone methyl in type 2 diabetes and stage 4 chronic kidney disease. N Engl J Med. 2013 Dec 26;369(26):2492-503. doi: 10.1056/NEJMoa1306033. Epub 2013 Nov 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bardoxolone methyl	Small molecule	20 mg	Oral

Indications