Education and Training
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Placebo
- drug: Dapagliflozin
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
Ages Eligible for Study
18 Years - 130 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting