Publication: TSUBAKI, a Study of Bardoxolone Methyl in Patients with Diabetic CKD

The Phase 2 study of bardoxolone methyl in Patients with Chronic Kidney Disease and Type 2 Diabetes (TSUBAKI) met its primary efficacy endpoint and, using the inulin clearance method, demonstrated that bardoxolone methyl treatment significantly increased measured GFR.

  • Bardoxolone methyl treatment was associated with an increase in measured GFR, as determined by inulin clearance.
  • Treatment with bardoxolone methyl was associated with improvements in eGFR and creatinine clearance.
  • There was no change in 24-hour excretion of creatinine suggesting that bardoxolone methyl does not affect muscle metabolism of creatinine.
  • Data confirm that serum creatinine based eGFR is an appropriate measure to assess kidney function in response to bardoxolone methyl treatment.