Last updated on May 2020

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: chronic renal insufficiency | Chronic renal failure
  • Age: Between 18 - 130 Years
  • Gender: Male or Female

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

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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