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Bardoxolone methyl and kidney function in CKD with type 2 diabetes
Pablo E Pergola1, Philip Raskin, Robert D Toto
1Renal Associates, San Antonio, TX 78215, USA. ppergola@raparesearch.com
The New England Journal of Medicine
|June 25, 2011
Summary
Bardoxolone methyl improved estimated glomerular filtration rate (GFR) in patients with advanced chronic kidney disease (CKD) and type 2 diabetes. These GFR improvements were sustained for 52 weeks, indicating potential therapeutic benefits for CKD.
Area of Science:
- Nephrology
- Pharmacology
- Clinical Trials
Background:
- Type 2 diabetes-associated chronic kidney disease (CKD) is a leading cause of kidney failure.
- Inflammation and oxidative stress are key drivers of CKD progression.
- Bardoxolone methyl, an oral antioxidant inflammation modulator, shows promise for CKD treatment.
Purpose of the Study:
- To evaluate the long-term efficacy and dose-response of bardoxolone methyl in patients with CKD and type 2 diabetes.
- To determine the effect of bardoxolone methyl on estimated glomerular filtration rate (GFR) over 52 weeks.
Main Methods:
- Phase 2, double-blind, randomized, placebo-controlled trial involving 227 adults with CKD (eGFR 20-45 mL/min/1.73 m²).
- Participants received placebo or bardoxolone methyl (25, 75, or 150 mg once daily).
- Primary outcome: change in eGFR at 24 weeks; secondary outcome: change at 52 weeks.
Main Results:
- Bardoxolone methyl significantly increased mean eGFR at 24 weeks compared to placebo (8.2-11.4 mL/min/1.73 m² increase).
- eGFR improvements were maintained at 52 weeks (5.8-10.5 mL/min/1.73 m² increase).
- Most frequent adverse event: dose-related muscle spasms; other events included hypomagnesemia and gastrointestinal effects.
Conclusions:
- Bardoxolone methyl demonstrated significant improvement in eGFR for patients with advanced CKD and type 2 diabetes.
- The observed eGFR benefits persisted through 52 weeks.
- Bardoxolone methyl shows potential as a therapeutic agent for managing chronic kidney disease.
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