What is the clinical evidence from this study?

Study design: RCT. Population: chronic kidney disease (n=4304). Intervention: dapagliflozin vs. matching placebo. Primary outcome: composite of sustained decline in eGFR of at least 50%, end-stage kidney disease, or kidney-related or cardiovascular death.

What question did this study set out to answer?

To determine the effects of dapagliflozin on kidney, cardiovascular, and mortality outcomes in chronic kidney disease patients categorized by type 2 diabetes status and underlying kidney disease etiology.

August 11, 2026The Lancet Diabetes & EndocrinologyOpen Access

Effects of dapagliflozin on major adverse kidney and cardiovascular events in patients with diabetic and non-diabetic chronic kidney disease: a prespecified analysis from the DAPA-CKD trial

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Key result

Dapagliflozin reduces major cardiorenal events ~36% to ~50% in CKD with or without diabetes.

n=4,304

Why the study?

Dapagliflozin reduces risk of kidney failure and heart failure in chronic kidney disease, but effects by diabetes status and CKD cause were unclear.

Does dapagliflozin reduce major adverse kidney and cardiovascular events in patients with chronic kidney disease, regardless of the presence of type 2 diabetes or underlying etiology?

Population

4304 patients with chronic kidney disease, 68% with type 2 diabetes, at 386 sites in 21 countries

Comparison

Dapagliflozin 10 mg once daily vs matching placebo, both as adjunct to standard care

Design

Multicentre, double-blind, placebo-controlled, randomized trial

Follow-up

Median 2.4 years (IQR 2.0-2.7)

Authors

DWDavid C. WheelerBoston University BSBergur V. StefánssonGentofte Hospital NJNiels JongsGeneral / Preventive / Lipids

Discussion

Member takes

Implication

Dapagliflozin significantly reduces the risk of major adverse kidney and cardiovascular events in patients with chronic kidney disease, with consistent benefits regardless of the presence of type 2 diabetes or the underlying cause of kidney disease.

Key Points

To determine the effects of dapagliflozin on kidney, cardiovascular, and mortality outcomes in chronic kidney disease patients categorized by type 2 diabetes status and underlying kidney disease etiology.
Multicenter, double-blind, placebo-controlled, randomized trial (NCT03036150) conducted across 386 sites in 21 countries involving 4,304 participants with chronic kidney disease (eGFR 25-75 mL/min per 1.73 m² and urinary albumin-to-creatinine ratio 200-5,000 mg/g).
Participants were randomly assigned (1:1) to receive dapagliflozin 10 mg once daily (n=2,152) or matching placebo (n=2,152) alongside standard care and followed for a median of 2.4 years.
Prespecified subgroup analyses assessed primary and secondary composite outcomes stratified by the presence of type 2 diabetes (n=2,906) or absence of diabetes (n=1,398), as well as chronic kidney disease etiology.
Dapagliflozin significantly lowered the primary composite outcome (sustained ≥50% eGFR decline, end-stage kidney disease, or renal/cardiovascular death) with consistent relative risk reductions in participants with type 2 diabetes (HR 0.64, 95% CI 0.52-0.79) and those without diabetes (HR 0.50, 95% CI 0.35-0.72; p-interaction=0.24).
Efficacy for the primary endpoint was consistent across underlying etiologies (p-interaction=0.53), including diabetic nephropathy (HR 0.63, 95% CI 0.51-0.78), glomerulonephritides (HR 0.43, 95% CI 0.26-0.71), and ischemic or hypertensive nephropathy (HR 0.75, 95% CI 0.44-1.26).
Secondary outcomes showed concordant reductions in patients with versus without diabetes for kidney-specific events (HR 0.57 vs 0.51; p-interaction=0.57), cardiovascular death or heart failure hospitalization (HR 0.70 vs 0.79; p-interaction=0.78), and all-cause mortality (HR 0.74 vs 0.52; p-interaction=0.25).

Study Design

Type

RCT (n=4,304)

Blinding

Double-blind

Randomization

1:1

Multicenter

Yes

Structured PICO

Does dapagliflozin reduce major adverse kidney and cardiovascular events in patients with chronic kidney disease, regardless of the presence of type 2 diabetes or underlying etiology?

Population

4,304 participants with chronic kidney disease (eGFR 25-75 mL/min/1.73m2 and UACR 200-5000 mg/g), with or without type 2 diabetes, followed for a median of 2.4 years.

Intervention

Dapagliflozin 10 mg once daily as an adjunct to standard care

Comparator

Matching placebo as an adjunct to standard care

Outcome

Composite of sustained decline in eGFR of at least 50%, end-stage kidney disease, or kidney-related or cardiovascular deathcomposite

Cite This Study

Wheeler et al. (2020) conducted an RCT in chronic kidney disease (n=4,304). dapagliflozin vs. matching placebo was evaluated on composite of sustained decline in eGFR of at least 50%, end-stage kidney disease, or kidney-related or cardiovascular death. Dapagliflozin reduced major adverse kidney and cardiovascular events in CKD patients with type 2 diabetes (HR 0.64; 95% CI 0.52-0.79) and without diabetes (HR 0.50; 95% CI 0.35-0.72).

synapsesocial.com/papers/6a7b70ae4aa654994ddc2d6c https://doi.org/10.1016/s2213-8587(20)30369-7

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Effects of dapagliflozin on major adverse kidney and cardiovascular events in patients with diabetic and non-diabetic chronic kidney disease: a prespecified analysis from the DAPA-CKD trial

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Cite This Study

Effects of dapagliflozin on major adverse kidney and cardiovascular events in patients with diabetic and non-diabetic chronic kidney disease: a prespecified analysis from the DAPA-CKD trial

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Cite This Study

Also Consider

Also Consider