Table 5.

Novelty of the SAPPHIRE study design

(i) Treatment extended beyond 6 months to collect longer-term safety and eGFR data compared with traditional Phase 2 studies focused on UACR in CKD

(ii) In the SAPPHIRE study, both UACR and eGFR are endpoints; having results from both in the same study will improve the planning and design of a subsequent renal outcomes study

(iii) The adaption of SAPPHIRE to include a 24 mg verinurad treatment period from Month 9 in a subset of patients following an interim analysis represents a step-wise approach to collect safety and efficacy data for the full dose range of verinurad in response to emerging PK, PD and safety results from SAPPHIRE and other trials, without affecting the scientific integrity of SAPPHIRE