A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes andCardiovascular Mortality in Patients with Chronic Kidney Disease - DAPA CKD

AstraZeneca AB0 sites4,000 target enrollmentDecember 19, 2016

Overview

No summary available.

Registry

who.int

Start Date

December 19, 2016

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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)
•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 2000
•F.1\.3 Elderly (\>\=65 years) yes

•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