Table 1.
Study objectives
Objective | Assessment |
---|---|
Primary | Dose–response effect of AZD5718 on urinary albumin-to-creatinine ratio from baseline to 20 weeks (on treatment with dapagliflozin as future standard of care) |
Secondary | Dose–response effect of AZD5718 on urinary albumin-to-creatinine ratio at 12 weeks (on current standard of care) Safety and tolerability of AZD5718 Effect of AZD5718 on ambulatory blood pressure Pharmacokinetics of AZD5718 Effect of AZD5718 on kidney function with and without dapagliflozin |
Exploratory | Dose–response effect of AZD5718 on urinary and plasma leukotriene E4 levels Sample collection for investigation of biomarkers that respond to treatment with AZD5718 Sample collection at baseline for investigation of biomarkers that may predict response to treatment with AZD5718 Effect of AZD5718 on diabetic retinopathy in patients with diabetic kidney disease Pharmacokinetics of dapagliflozin after 8 weeks |