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Kidney Week

Abstract: SA-PO146

Primary Efficacy Analyses from a Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients with Type 1 Diabetes

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical


  • Silva, Arnold L., Boise Kidney & Hypertension Institute, Meridian, Idaho, United States
  • Awad, Ahmed M., Clinical Research Consultants, LLC, Kansas City, Missouri, United States
  • Block, Geoffrey A., Colorado Kidney Care, Denver, Colorado, United States
  • Chin, Melanie, Reata Pharmaceuticals, Irving, Texas, United States
  • Meyer, Colin John, Reata Pharmaceuticals, Irving, Texas, United States
  • Schroeder, Kevin, Ohio Kidney Consultants, Columbus, Ohio, United States
  • Pergola, Pablo E., Renal Associates, PA, San Antonio, Texas, United States

Bardoxolone methyl (BARD) has been shown to significantly increase eGFR in patients with CKD and type 2 diabetes or Alport syndrome suggesting that the anti-inflammatory and anti-fibrotic effects of BARD may target the common pathways contributing to GFR loss in multiple forms of CKD. As a result, a Phase 2 trial (PHOENIX, NCT03366337) was initiated to test the hypothesis that BARD will improve kidney function in patients with CKD due to type 1 diabetes mellitus (T1DM) as well as other forms of CKD.


The Phase 2 open-label, multicenter study enrolled a cohort of patients T1DM confirmed by fasting C-peptide levels. Eligible patients were 18 to 65 years of age with eGFR values between 30 to 90 mL/min/1.73 m2 and urine albumin to creatinine ratio (UACR) ≤ 2500 mg/g. Patients received BARD at an initial dose of 5 mg, dose-escalated to 20 mg (for patients with baseline UACR ≤ 300 mg/g) or to 30 mg (for patients with baseline UACR > 300 mg/g) and were treated for 12 weeks. The primary efficacy endpoint was the change from baseline eGFR after 12 weeks of treatment. Interim results for the cohort enrolling patients with T1DM are described herein.


At data cutoff on May 15th, 2018, 3/19 (16%) of the enrolled patients with T1DM had completed the study. From a mean (± SE) baseline eGFR of 68.2 ± 3.8 mL/min/1.73 m2, BARD treatment resulted in a significant increase from baseline in eGFR of 7.9 ± 2.9 mL/min/1.73 m2 (p=0.008) at Week 12. No patients have discontinued from the study and no serious AEs considered related to BARD have been reported in this ongoing trial.


BARD was generally well tolerated and significantly increased eGFR in patients with T1DM. In patients with other forms of CKD, short term eGFR increases with BARD are predictive of durable eGFR improvements and additional studies are needed to study the longer-term effects of BARD on eGFR in T1DM.

Mean Change from Baseline in eGFR (mL/min/1.73 m2)
 Week 1Week 4Week 8Week 12
Mean ± SE1.4 ± 1.36.2 ± 1.56.6 ± 1.97.5 ± 2.7


  • Commercial Support – Reata Pharmaceuticals