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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Kidney Disease

In brief

The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.

Key facts

Study ID

NCT03036150

Run by

AstraZeneca

People needed

4304

Starts

2017-02-02

Expected to finish

2020-06-12

Last updated by the study team

2021-07-07

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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,

You may not qualify if…

• 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

Where it is running

• Research Site — Hawaiian Gardens, California, United States
• Research Site — Lomita, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Palo Alto, California, United States
• Research Site — San Dimas, California, United States
• Research Site — San Ramon, California, United States
• Research Site — Vista, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — Boynton Beach, Florida, United States
• Research Site — Boynton Beach, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami Lakes, Florida, United States
• Research Site — Naples, Florida, United States
• Research Site — New Port Richey, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Iowa City, Iowa, United States
• Research Site — Topeka, Kansas, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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