A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
Trial ID or NCT#
NCT03036150
Status
NOT RECRUITING
Purpose
The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.
Official Title
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
Eligibility Criteria
Ages Eligible for Study: 18 Years to 130 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
View on ClinicalTrials.gov
