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Forxiga


Title A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with Chronic Kidney Disease (Forxiga)
Therapeutic Area Chronic Kidney Disease, Diabetes Type 2
Principal Investigator Daniel Weiner MD, MS
Min Age 18 Years
Gender All
Contact Jasmine Rollins
617-636-9423
More Information https://clinicaltrials.gov/ct2/show/NCT03036150

Overview

Dapagliflozin (ForxigaTM/FarxigaTM) is currently used for treating type 2 diabetic patients worldwide and is approved by the U.S. Food and Drug Administration (FDA) for type 2 diabetes. Because it is being evaluated in subjects with chronic kidney disease, with or without type 2 diabetes, its use in this study is considered investigational. Previous data from dapagliflozin and similar type of medications indicate that they might have beneficial effects on chronic kidney disease. Dapagliflozin decreases blood sugar in diabetic patients but should not influence blood sugar if you do not have diabetes. This research study is carried out to see if dapagliflozin is effective in chronic kidney disease by preventing the gradual loss of kidney function and in the long run to improve the survival for patients with chronic kidney disease.

Study Details

Inclusion Criteria

  • eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula)
  • 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

  • History of organ transplantation
  • Type 1 diabetes mellitus
  • New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment

Study Requirements

Your participation in this study involves about 9-17 visits over approximately 1.5-4 years depending on when you enter the study. At these visits you will for example be asked to provide blood and urine samples, undergo physical examinations and complete health questionnaires. Each visit should take less than 2 hours to complete.