Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria

• Status: Completed
• Trial end date: 2018-08-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical research study is to evaluate signals of potential clinical benefit of the combination of Verinurad and Febuxostat in lowering concentrations of circulating uric acid and thus improving kidney or cardiovascular status of patients with hyperuricemia, albuminuria, and Type 2 diabetes (T2DM).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Febuxostat; Uric Acid; Verinurad

Criteria

Inclusion Criteria:

• Serum Uric Acid ≥6.0 mg/dL

• eGFR ≥30 mL/min/1.73 m2

• UACR between 30 mg/g and 3500 mg/g inclusive

• Diagnosed with T2DM

Exclusion Criteria:

• Treated with any drug for hyperuricemia in the 6 months preceding randomization.Drugs for hyperuricemia include all XO inhibitors (allopurinol, febuxostat and topiroxostat) and URAT1 inhibitors (lesinurad, verinurad, probenecid, and benzbromarone)

• Prior history of gout, unless prophylaxis therapy isn't required

• Patients who are pregnant, lactating, or planning to become pregnant

• Patients unsuitable or unable to undergo MRI assessment