Dapagliflozin in Patients with CKD
Research type
Research Study
Full title
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with Chronic Kidney Disease
IRAS ID
224151
Contact name
Robert Hunter
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2016-003896-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 13 days
Research summary
Chronic kidney disease (CKD) affects approximately 10% of the adult population worldwide. The most common causes of CKD are diabetes, high blood pressure and chronic glomerulonephritis, a group of diseases that injure the part of the kidney that filters blood. Dapagliflozin reduces glucose reabsorption from the kidney back into the bloodstream, resulting in less glucose circulating in the blood; which has been shown to lead to a reduction in body weight, blood pressure and albuminuria (the presence of albumin in the urine, typically as a symptom of kidney disease), all of which are known risk factors for the progression of CKD. It is thought that dapagloflozin therefore provides protection for the kidneys. Other drugs of this type are not currently being used for patients with CKD.
AstraZeneca are running this study in many countries around the world for approximately 45 months. Both type II diabetic and non-diabetic patients can participate in the study provided they have a diagnosis of both CKD and albuminuria. In looking at the effect of dapagliflozin we hope to see whether patients have a reduction in the worsening of their condition. We will also be looking at the safety and tolerability of dapagliflozin.
Patients will be automatically assigned to either the dapagliflozin tablets or placebo (sugar) tablets at the start of the study and the treatment each patient receives will not be known to AstraZeneca or their doctor. Study patients will have their medical history reviewed, have an ECG, blood tests and vital signs taken, complete quality of life questionnaires and have physical examinations performed to check on their overall health and wellbeing. Following enrollment into the study, visits will be completed at 14 days, 60 days, 120 days, 240 days, 360 days and then every 4 months thereafter until the study closes.
REC name
West of Scotland REC 1
REC reference
17/WS/0071
Date of REC Opinion
5 May 2017
REC opinion
Further Information Favourable Opinion