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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03036150
• Date of registration: 26/01/2017
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease Dapa-CKD
• Scientific title: A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
• Date of first enrolment: February 2, 2017
• Target sample size: 4304
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03036150
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Canada, China, Denmark, Germany, Hungary, India, Japan, Korea, Republic of, Mexico, Peru, Philippines, Poland, Russian Federation, Spain, Sweden, Ukraine, United Kingdom, United States, Vietnam

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 130 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Kidney Disease

Intervention(s)

Drug: Dapagliflozin

Drug: Placebo

Primary Outcome(s)

Time to the first occurrence of any of the components of the composite: =50% sustained decline in eGFR or reaching ESRD or CV death or renal death. [Time Frame: From randomization (Day 0) up to approximately 4 years]

Secondary Outcome(s)

Time to the first occurrence of either of the components of the composite: CV death or hospitalization for heart failure. [Time Frame: From randomization (Day 0) up to approximately 4 years]

Time to the first occurrence of any of the components of the composite: =50% sustained decline in eGFR or reaching ESRD or renal death. [Time Frame: From randomization (Day 0) up to approximately 4 years]

Time to death from any cause. [Time Frame: From randomization (Day 0) up to approximately 4 years]

Secondary ID(s)

D169AC00001

2016-003896-24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors