A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes

Brief Description Of Study

This is a randomised, double-blind, parallel-group study. 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. Dapagliflozin will be compared with placebo (inactive medication), in addition to your current chronic kidney disease medication. The placebo tablet will look identical with the dapagliflozin tablet. A positive effect of dapagliflozin is expected, but cannot be guaranteed.

Clinical Study Identifier: 03036150

Detailed Study Description

You will receive either placebo (inactive medication) or identical looking dapagliflozin 10 mg (active medication). In some circumstances, your study doctor may lower your dose to 5 mg dapagliflozin/placebo, either temporarily or for the remainder of the study. You have an equal chance of receiving placebo or dapagliflozin. Which treatment you receive is decided at random by a computer (purely by chance, like the tossing of a coin). Neither you nor the study doctor will know which treatment you have received. The study medications should be taken once a day, at approximately the same time every day, and be swallowed whole. Your participation in this study involves about 9-17 visits over approximately 1.5-4 years depending on when you enter the study. This may be shortened or extended (and visit added or removed) as the study will be closed when enough data has been collected to evaluate the results. At these visits you will for example be asked to provide blood and urine samples, undergo physical examinations and complete health questionnaires.

Additional Information About The Study

Chronic kidney disease (CKD) affects approximately 10% of the adult population worldwide. The most common causes of CKD are diabetes, hypertension and chronic glomerulonephritis. Treatment for CKD encompasses angiotensin converting enzyme inhibitor (ACE-I) and angiotensin II receptor blockers (ARBs), lipid and blood pressure (BP) control as well as a tight glucose control in diabetic patients.



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To: Research Study Investigator
Subject: I am interested in participating in your Research Study
Dear Investigator,
I'm interested in learning more about and participating in your research study named: A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes
I am hoping to hear back from you and discuss details of the study

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