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Abstract: SA-OR086

Verinurad Plus Febuxostat Rapidly Reduces Albuminuria in Type 2 Diabetes Independent of Preexisting Kidney Disease

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Stack, Austin G., University Hospital Limerick, Limerick, Ireland
  • Dronamraju, Nalina, AstraZeneca R&D, Gaithersburg, Maryland, United States
  • Parkinson, Joanna, AstraZeneca R&D, Gothenburg, Sweden
  • Johansson, Susanne, AstraZeneca R&D, Gothenburg, Sweden
  • Johnsson, Eva K.A., AstraZeneca R&D, Gothenburg, Sweden
  • Erlandsson, Fredrik, AstraZeneca R&D, Gothenburg, Sweden
  • Terkeltaub, Robert, University of California, San Diego, California, United States
Background

Elevated serum uric acid predicts new-onset albuminuria, the earliest clinical indicator of kidney disease. We evaluated the effects of intensive uric acid lowering on albuminuria by combining verinurad with febuxostat in patients with type 2 diabetes mellitus (T2DM) and albuminuria.

Methods

In a phase 2, parallel group, multicenter, randomized, double-blind, placebo-controlled trial (NCT03118739), adults with T2DM, albuminuria, and hyperuricemia were randomized to verinurad 9 mg plus febuxostat 80 mg once daily, or placebo, and followed for 24 wks. The primary outcome was reduction in urinary albumin to creatinine ratio (UACR) at 12 wks compared with baseline. Changes in UACR were evaluated according to baseline characteristics including UACR and estimated glomerular filtration rate (eGFR).

Results

Baseline UACR was 459 (±825) mg/g in the verinurad plus febuxostat group (n=32) and 412 (±548) mg/g in the placebo group (n=28). Improvement in UACR with verinurad plus febuxostat was rapid, sustained over time, and met prespecified criteria for significance, with 39%, 39%, and 49% reductions vs placebo at wks 1, 12, and 24, respectively (wk 12 90% CI –62%, –4%; P=0.0747). Reduction was consistent across subgroups including those based on UACR and eGFR (Figure). Verinurad plus febuxostat was well tolerated.

Conclusion

Intensive urate lowering with verinurad plus febuxostat significantly reduced UACR in patients with T2DM, albuminuria, and hyperuricemia. Reduction was rapid, sustained, and similar regardless of baseline eGFR and degree of albuminuria. A larger study is underway to determine which patient groups might benefit most from verinurad combination therapy.

Funding

  • Commercial Support