Table 3.

Key study endpoints in SAPPHIRE

	Endpoint
Primary endpoint	Change from baseline in UACR at 6 months
Secondary endpoints	Change from baseline in UACR at 12 months
	Change from baseline in UACR sUA at 6 and 12 months
	Change from baseline in UACR and sUA at 6 months for dose–response assessment up to 12 mg verinurad dose
	Change from baseline in eGFR at 6 and 12 months
	Change from baseline in creatinine at 6 and 12 months
	Change from baseline in cystatin-C at 6 and 12 months
Exploratory endpoints	Plasma exposure of verinurad, allopurinol and oxypurinol (active metabolite of allopurinol)
	Change from baseline at 6 months in kidney oxygenation, blood flow parameters, cortical and kidney volume measurements, MRI relaxation and diffusion measurements, pulse wave velocity
	Change from baseline at 6 and 12 months and EOT in blood pressure, NT-proBNP, high sensitivity CRP, high sensitivity troponin 1, flow-mediated dilation, emerging urine and serum biomarkers, AST, ALT
	Change from baseline at 6 and 12 months in UACR in pre-specified subsets of patients
	Change in renal function assessments at 6 and 12 months, and EOT
	Plasma concentrations of verinurad, allopurinol and oxypurinol, sUA, UACR and other PD variables
	Change in tophi from baseline at 6 months and at EOT
	Incidence of gout flare during the first titration period, the overall titration period and the whole study
Safety endpoints	Rates of AEs and SAEs, including cardiovascular events
	Change in vital signs, electrocardiograms and clinical laboratory parameters

ALT, alanine aminotransferase; AST, aspartate transaminase; CRP, C-reactive protein; EOS, end-of-study; EOT, end-of-treatment; SAE, serious AE.