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

AstraZeneca KK0 sites240 target enrollmentMay 16, 2018

Overview

No summary available.

Registry

who.int

Start Date

May 16, 2018

End Date

June 12, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•Provision of signed informed consent prior to any study specific procedures
•\- Female or male aged 18 years or more at the time of consent
•\- eGFR 25 or more and 75 mL/min/1\.73 m2 (CKD\-EPI Formula) or less at visit 1
•\- Evidence of increased albuminuria 3 months or more before visit 1 and UACR 200 or more and 5000 mg/g or less 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

•\- 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