A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with Chronic Kidney Disease - Dapa-CKD
Study identifier:D169AC00001
ClinicalTrials.gov identifier:NCT03036150
EudraCT identifier:2016-003896-24
CTIS identifier:N/A
Study Complete
Official Title
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with Chronic Kidney Disease
Medical condition
Chronic Kidney Disease
Phase
Phase 3
Healthy volunteers
No
Study drug
Dapagliflozin, Placebo
Sex
All
Actual Enrollment
4304
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 02 Feb 2017
Primary Completion Date: 12 Jun 2020
Study Completion Date: 12 Jun 2020
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2021 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dapagliflozin Patients will be randomized 1:1 to either dapagliflozin or placebo. | Drug: Dapagliflozin 10 mg or 5 mg tablets given once daily, per oral use. Other Name: Forxiga TM Other Name: Farxiga TM |
| Placebo Comparator: Placebo Placebo matching dapagliflozin. | Drug: Placebo Placebo matching dapagliflozin 10 mg or 5 mg |
