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A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
Not Recruiting
Trial ID: NCT03036150
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
Stanford Investigator(s)
Margaret Yu
Clinical Associate Professor, Medicine - Nephrology
Eligibility
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
Intervention(s):
drug: Placebo
drug: Dapagliflozin
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305