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

• Status: Completed
• Trial end date: 2020-06-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Dapagliflozin

Criteria

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