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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease

Treatments: Drug: Dapagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03036150

D169AC00001

2016-003896-24 (EudraCT Number)

Details and patient eligibility

About

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

Full description

This is an international, multicentre, event-driven, randomized, double-blind, parallel group, placebo-controlled study, evaluating the effect of dapagliflozin versus placebo, given once daily in addition to standard of care, to prevent the progression of chronic kidney disease (CKD) or cardiovascular (CV)/renal death.

Enrollment: 4,304 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,304 participants in 2 patient groups, including a placebo group

Dapagliflozin

Experimental group

Description:

Patients will be randomized 1:1 to either dapagliflozin or placebo.

Treatment:

Drug: Dapagliflozin

Placebo

Placebo Comparator group

Description:

Placebo matching dapagliflozin.

Treatment:

Drug: Placebo