Trial Search Results

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 accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Stanford Investigator(s):

Intervention(s):

  • Drug: Dapagliflozin
  • Drug: Placebo

Phase:

Phase 3

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

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting