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Rationale, design, demographics, and baseline characteristics of the randomised, controlled, phase 2b SAPPHIRE study of verinurad plus allopurinol in patients with chronic kidney disease and hyperuricaemia

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Published:11th Aug 2021

Author: Heerspink HJL, Stack AG, Terkeltaub R, Greene TA, Inker LA, Bjursell M et al.

Source: Nephrology Dialysis Transplantation

Availability: Free full text

Ref.:Nephrol Dial Transplant. 2021 Aug 12:gfab237.

DOI:10.1093/ndt/gfab237

Rationale, design, demographics, and baseline characteristics of the randomised, controlled, phase 2b SAPPHIRE study of verinurad plus allopurinol in patients with chronic kidney disease and hyperuricaemia

Background: Verinurad is a human uric acid transporter (URAT1) inhibitor known to decrease serum uric acid (sUA) levels and may reduce albuminuria. In a Phase 2a study (NCT03118739), treatment with verinurad + febuxostat lowered urine albumin-to-creatinine ratio (UACR) at 12 weeks by 39% (90% confidence interval: 4%, 62%) among patients with type 2 diabetes mellitus, hyperuricaemia and albuminuria. The Phase 2 b, randomised, placebo-controlled Study of verinurAd and alloPurinol in Patients with cHronic kIdney disease and hyperuRicaEmia (SAPPHIRE; NCT03990363) will examine the effect of verinurad + allopurinol on albuminuria and estimated glomerular filtration rate (eGFR) slope among patients with chronic kidney disease (CKD) and hyperuricaemia.

Methods: Adults (≥18 years of age) with CKD, eGFR ≥25 mL/min/1.73 m2, UACR 30-5000 mg/g and sUA ≥6.0 mg/dL will be enrolled. Approximately 725 patients will be randomised 1:1:1:1:1 to 12, 7.5 or 3 mg verinurad + allopurinol, allopurinol or placebo. An 8-week dose-titration period will precede a 12-month treatment period; verinurad dose will be increased to 24 mg at month 9 in a subset of patients in the 3 mg verinurad + allopurinol arm. The primary efficacy endpoint is change from baseline in UACR at 6 months. Secondary efficacy endpoints include changes in UACR, eGFR and sUA from baseline at 6 and 12 months.

Conclusions: This study will assess the combined clinical effect of verinurad + allopurinol on kidney function in patients with CKD, hyperuricaemia and albuminuria, and whether this combination confers renoprotection beyond standard-of-care.

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Chronic Kidney Disease (CKD) is a disease that can often lead to a need for haemodialysis and kidney transplantation. New CKD treatments are emerging which focus on delaying CKD disease progression and the need for transplantation.

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