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ASN leads the fight to prevent, treat, and cure kidney diseases throughout the world by educating health professionals and scientists, advancing research and innovation, communicating new knowledge, and advocating for the highest quality care for patients.

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Kidney Week

Abstract: INFO12-SA

Rationale and Design of a Phase 2b Study of Verinurad Plus Allopurinol in Patients with CKD and Hyperuricemia

Session Information

  • Informational Posters - III
    November 09, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)


  • L Heerspink, Hiddo Jan, University Medical Center Groningen, Groningen, Netherlands
  • Greene, Tom, University of Utah School of Medicine, Salt Lake City, Utah, United States
  • Inker, Lesley, Tufts Medical Center, Boston, Massachusetts, United States
  • Stack, Austin G., University of Limerick, Limerick, Ireland
  • Terkeltaub, Robert, University of California San Diego, La Jolla, California, United States
  • Perl, Shira, AstraZeneca R&D, Gaithersburg, Maryland, United States
  • Dronamraju, Nalina, AstraZeneca R&D, Gaithersburg, Maryland, United States
  • Erlandsson, Fredrik, AstraZeneca R&D, Mölndal, Sweden
  • Perkovic, Vlado, The George Institute Australia, Newtown, New South Wales, Australia

Elevated serum uric acid (sUA) predicts CKD progression, but a relationship between sUA and kidney outcomes is not proven. In a phase 2a study (NCT03118739), verinurad+febuxostat lowered sUA by 60% and albuminuria by 39% at Wk 12 in patients (pts) with T2DM and hyperuricemia. This phase 2b randomized, placebo-controlled study will examine the effect of intensive urate lowering on kidney function (estimated glomerular filtration rate [eGFR]) and albumin/creatinine ratio (ACR) in pts with CKD (±T2DM) and hyperuricemia and provide insight into potential treatment benefit.
Pts will be ≥18 y with CKD, with eGFR ≥25 mL/min/1.73 m2, ACR 30–5000 mg/g and sUA ≥6.0 mg/dL. 725 pts will be randomized equally to high, intermediate or low dose verinurad+allopurinol, allopurinol or placebo (Figure). An 8-wk dose-titration period will precede a ≥52-wk treatment stage; all pts will receive treatment until the last randomized pt has been treated for 60 wks. Primary endpoint is change from baseline (BL) in ACR at 6 months. Secondary endpoints include changes in ACR and sUA from BL at 6 and 12 months. A Bayesian analysis will quantify the joint implications of estimated treatment effects on ACR and eGFR slope for clinical benefit. The effects of verinurad+allopurinol combination on measurable structural and functional kidney changes will be assessed using MRI and various cardio-renal biomarkers.
This study will assess the clinical effect of verinurad+allopurinol on kidney function in CKD pts with hyperuricemia, and if intensive urate lowering confers renoprotection beyond SoC. Results are expected by 2022.


  • AstraZeneca