A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease

This is an international, multicentre, event-driven, randomized, double-blind, parallel
group, placebo-controlled study, evaluating the effect of dapagliflozin versus placebo, given
once daily in addition to standard of care, to prevent the progression of chronic kidney
disease (CKD) or cardiovascular (CV)/renal death.

Inclusion Criteria:

- Provision of signed informed consent prior to any study specific procedures

- Female or male aged ≥18 years at the time of consent

- eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1

- Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and
≤5000 mg/g at visit 1

- Stable, and for the patient maximum tolerated labelled daily dose, treatment with
ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated,

Exclusion Criteria:

- Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis
or ANCA-associated vasculitis

- Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for
primary or secondary renal disease within 6 months prior to enrolment

- History of organ transplantation

- Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or
previous intolerance of an SGLT2 inhibitor

- Type 1 diabetes mellitus

- New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of
enrolment

- MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to
enrolment