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
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