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Abstract: TH-PO1039

Primary Efficacy Analyses from a Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients with IgA Nephropathy

Session Information

Category: Glomerular Diseases

  • 1203 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Block, Geoffrey A., Colorado Kidney Care, Denver, Colorado, United States
  • Appel, Gerald B., Columbia University College of Physicians and Surgeons, Scarsdale, New York, United States
  • Awad, Ahmed M., Clinical Research Consultants, LLC, Kansas City, Missouri, United States
  • Betts, Judith A., Austin Kidney Associates, Austin, Texas, United States
  • Chin, Melanie, Reata Pharmaceuticals, Irving, Texas, United States
  • Meyer, Colin John, Reata Pharmaceuticals, Irving, Texas, United States
  • Pergola, Pablo E., Renal Associates, PA, San Antonio, Texas, United States
  • Rastogi, Anjay, University of California at Los Angeles Medical Center, Los Angeles, California, United States
  • Rizk, Dana, University of Alabama, Birmingham, Alabama, United States
  • Schroeder, Kevin, Ohio Kidney Consultants, Columbus, Ohio, United States
  • Silva, Arnold L., Boise Kidney & Hypertension Institute, Meridian, Idaho, United States
Background

Bardoxolone methyl (BARD) has been shown to significantly increase eGFR in patients with CKD and type 2 diabetes and 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 IgA nephropathy (IgAN) as well as other forms of CKD.

Methods

The Phase 2 open-label, multicenter study enrolled a cohort of 26 patients with biopsy-confirmed IgAN. 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 IgAN are described herein.

Results

At data cutoff on May 15th, 2018, 5/26 (19%) of the enrolled patients with IgAN had completed the study. From a mean (± SE) baseline eGFR of 46.2 ± 2.5 mL/min/1.73 m2, BARD treatment resulted in a significant increase from baseline in eGFR of 7.8 ± 1.8 mL/min/1.73 m2 (p<0.0001) at Week 12. The improvements were consistent, and 4 of the 5 (80%) patients had increases from baseline in eGFR > 5 mL/min/1.73 m2 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.

Conclusion

BARD was generally well tolerated and significantly increased eGFR in patients with IgAN. 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 IgAN.

Funding

  • Commercial Support