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Major Finding: Bardoxolone methyl improved eGFR in diabetic CKD patients by a mean of 10.1 mL/minute per 1.73 m
Data Source: Phase IIb randomized, double-blind, placebo-controlled trial enrolling 227 patients.
Disclosures: The study was funded by the drug's sponsor, Reata Pharmaceuticals. The lead investigator said he had no conflicts of interest.
A 24-week course of bardoxolone methyl, an experimental antioxidant inflammation modulator, improved estimated glomerular filtration rates in chronic kidney disease patients with type 2 diabetes, according to a randomized phase IIb study funded by Reata Pharmaceuticals Inc.
A phase III study slated to start next year will test whether the mean eGFR improvement of 10.1 mL/minute per 1.73 m
“You want to make sure this drug will be associated with a clinical outcome,” said Dr. Pergola, the lead investigator of the phase IIb study.
Patients in the randomized, double-blind, placebo-controlled trial were assigned to 25-mg, 75-mg, or 150-mg daily doses of bardoxolone or to placebo. Each group had 57 subjects, except the 150-mg group, which had 56.
In addition to type 2 diabetes, subjects had stage 3b or 4 chronic kidney disease (CKD), with an eGFR of 20-45 mL/min per 1.73m
Their median age was 67 years, and all were on standard-of-care therapy – 98% of patients took ACE inhibitors or angiotensin-receptor blockers.
At 24 weeks, bardoxolone patients had a mean eGFR gain of 10.1 mL/minute per 1.73 m
About 73% (124) of patients in each bardoxolone group had at least a 10% eGFR increase; 25% (43) had more than a 50% increase.
Increased eGFRs also correlated with decreased blood-urea-nitrogen levels, decreased serum phosphorous and uric acid levels, and improved CKD stage.
Adverse events were more common in the bardoxolone groups; 49% reported muscle spasms, compared with 12% in the placebo group. The spasms were thought to be treatment related, as were nausea, hypomagnesemia, and diminished appetite.
Major Finding: Bardoxolone methyl improved eGFR in diabetic CKD patients by a mean of 10.1 mL/minute per 1.73 m
Data Source: Phase IIb randomized, double-blind, placebo-controlled trial enrolling 227 patients.
Disclosures: The study was funded by the drug's sponsor, Reata Pharmaceuticals. The lead investigator said he had no conflicts of interest.
A 24-week course of bardoxolone methyl, an experimental antioxidant inflammation modulator, improved estimated glomerular filtration rates in chronic kidney disease patients with type 2 diabetes, according to a randomized phase IIb study funded by Reata Pharmaceuticals Inc.
A phase III study slated to start next year will test whether the mean eGFR improvement of 10.1 mL/minute per 1.73 m
“You want to make sure this drug will be associated with a clinical outcome,” said Dr. Pergola, the lead investigator of the phase IIb study.
Patients in the randomized, double-blind, placebo-controlled trial were assigned to 25-mg, 75-mg, or 150-mg daily doses of bardoxolone or to placebo. Each group had 57 subjects, except the 150-mg group, which had 56.
In addition to type 2 diabetes, subjects had stage 3b or 4 chronic kidney disease (CKD), with an eGFR of 20-45 mL/min per 1.73m
Their median age was 67 years, and all were on standard-of-care therapy – 98% of patients took ACE inhibitors or angiotensin-receptor blockers.
At 24 weeks, bardoxolone patients had a mean eGFR gain of 10.1 mL/minute per 1.73 m
About 73% (124) of patients in each bardoxolone group had at least a 10% eGFR increase; 25% (43) had more than a 50% increase.
Increased eGFRs also correlated with decreased blood-urea-nitrogen levels, decreased serum phosphorous and uric acid levels, and improved CKD stage.
Adverse events were more common in the bardoxolone groups; 49% reported muscle spasms, compared with 12% in the placebo group. The spasms were thought to be treatment related, as were nausea, hypomagnesemia, and diminished appetite.
Major Finding: Bardoxolone methyl improved eGFR in diabetic CKD patients by a mean of 10.1 mL/minute per 1.73 m
Data Source: Phase IIb randomized, double-blind, placebo-controlled trial enrolling 227 patients.
Disclosures: The study was funded by the drug's sponsor, Reata Pharmaceuticals. The lead investigator said he had no conflicts of interest.
A 24-week course of bardoxolone methyl, an experimental antioxidant inflammation modulator, improved estimated glomerular filtration rates in chronic kidney disease patients with type 2 diabetes, according to a randomized phase IIb study funded by Reata Pharmaceuticals Inc.
A phase III study slated to start next year will test whether the mean eGFR improvement of 10.1 mL/minute per 1.73 m
“You want to make sure this drug will be associated with a clinical outcome,” said Dr. Pergola, the lead investigator of the phase IIb study.
Patients in the randomized, double-blind, placebo-controlled trial were assigned to 25-mg, 75-mg, or 150-mg daily doses of bardoxolone or to placebo. Each group had 57 subjects, except the 150-mg group, which had 56.
In addition to type 2 diabetes, subjects had stage 3b or 4 chronic kidney disease (CKD), with an eGFR of 20-45 mL/min per 1.73m
Their median age was 67 years, and all were on standard-of-care therapy – 98% of patients took ACE inhibitors or angiotensin-receptor blockers.
At 24 weeks, bardoxolone patients had a mean eGFR gain of 10.1 mL/minute per 1.73 m
About 73% (124) of patients in each bardoxolone group had at least a 10% eGFR increase; 25% (43) had more than a 50% increase.
Increased eGFRs also correlated with decreased blood-urea-nitrogen levels, decreased serum phosphorous and uric acid levels, and improved CKD stage.
Adverse events were more common in the bardoxolone groups; 49% reported muscle spasms, compared with 12% in the placebo group. The spasms were thought to be treatment related, as were nausea, hypomagnesemia, and diminished appetite.
From the Annual Meeting of the American Society of Nephrology