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EMPA-KIDNEY: A large trial designed to reflect the broad range of adults with CKD1-3

Patients with varying comorbidities, eGFR and uACR levels, and treatment history were enrolled based on the eligibility criteria (N=6609 adults; mean age 63 years)

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  • *
    History of diabetes was defined as a patient-reported history of diabetes of any type, use of glucose-lowering medication, or a glycated haemoglobin level of ≥48 mmol per mole (6.5%) at the Randomisation visit. More than 96% of patients with diabetes had type 2.
  • †
    Values represent the measurement recorded at the randomization visit or the most recent local laboratory result recorded before randomization. For the uACR, albumin was measured in milligrams and creatinine was measured in grams.
  • ‡
    History of CVD was defined as a patient-reported history of myocardial infarction, heart failure, stroke, transient ischaemic attack, or peripheral arterial disease.

Key exclusion criteria:

  • T2D and prior ASCVD with eGFR >60 mL/min/1.73 m2
  • T1D
  • Maintenance dialysis, functioning kidney transplant, or scheduled transplant
  • Polycystic kidney disease or requiring/recent history of IV immunosuppressive therapy or >45 mg of prednisone or equivalent

EMPA-KIDNEY trial design:

A randomized, parallel-group, double-blind, placebo-controlled study of 6609 adult patients with CKD, evaluating the efficacy and safety of JARDIANCE 10 mg (n=3304) vs placebo (n=3305) as an adjunct to standard of care therapy. The primary endpoint was a composite of: sustained decrease in eGFR of ≥40% from baseline, sustained decrease in eGFR to <10 mL/min/1.73 m2, ESKD (the initiation of maintenance dialysis or receipt of a kidney transplant), or CV or renal death.

The trial was stopped early because prespecified conditions for efficacy were
met at the formal interim analysis1

IN ADULTS WITH CKD WITH OR WITHOUT  T2D

JARDIANCE helps reduce the risk of kidney disease progression and CV death1

ico_Placehoder (1)
ico_Placehoder (1)

The primary composite endpoint in EMPA-KIDNEY was kidney disease progression‡ or CV death.

  • *
    Actual event rates for kidney disease progression or CV death: 16.9% (n=558/3305) for placebo vs 13.1% (n=432/3304) for JARDIANCE.
  • †
    Standard of care: All patients received a RAASi unless an investigator judged that a RAASi was not indicated or tolerated.1
  • ‡
    Progression is defined as sustained decrease in eGFR of ≥40% from baseline, sustained decrease in eGFR to <10 mL/min/ 1.73 m2, ESKD (the initiation of maintenance dialysis or receipt of a kidney transplant), or renal death.

Risk reduction was generally consistent across prespecified subgroups:

  • With and without T2D
  • eGFR categories
  • Underlying cause of CKD
  • With and without background use of RAASi

EMPA-KIDNEY trial design:

A randomized, parallel-group, double-blind, placebo-controlled study of 6609 adult patients with CKD, evaluating the efficacy and safety of JARDIANCE 10 mg (n=3304) vs placebo (n=3305) as an adjunct to standard of care therapy. The primary endpoint was a composite of: sustained decrease in eGFR of ≥40% from baseline, sustained decrease in eGFR to <10 mL/min/1.73 m2, ESKD (the initiation of maintenance dialysis or receipt of a kidney transplant), or CV or renal death.

IN ADULTS WITH CKD WITH OR WITHOUT  T2D

JARDIANCE helps keep patients out of the hospital by reducing the risk of first and recurrent hospitalization1*

ckd-efficacy-14_0
ckd-efficacy-14_0
  • *
    Hospitalization for any cause was a key secondary outcome of the EMPA-KIDNEY trial. The analysis of hospitalizations for any cause included the first and all subsequent events.
  • †
    Standard of care: All patients received a RAASi unless an investigator judged that a RAASi was not indicated or tolerated.

Fewer hospitalizations with JARDIANCE:

  • In the JARDIANCE group, 1611 hospitalizations occurred in 960 patients (24.8 events/100 patient-years)
  • In the placebo group, 1895 hospitalizations occurred in 1035 patients (29.2 events/100 patient-years)

EMPA-KIDNEY trial design:

A randomized, parallel-group, double-blind, placebo-controlled study of 6609 adult patients with CKD, evaluating the efficacy and safety of JARDIANCE 10 mg (n=3304) vs placebo (n=3305) as an adjunct to standard of care therapy. The primary endpoint was a composite of: sustained decrease in eGFR of ≥40% from baseline, sustained decrease in eGFR to <10 mL/min/1.73 m2, ESKD (the initiation of maintenance dialysis or receipt of a kidney transplant), or CV or renal death.

ARR=absolute risk reduction; ASCVD=atherosclerotic cardiovascular disease; CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration; ESKD=end-stage kidney disease; HR=hazard ratio; IV=intravenous; NNT=number needed to treat; RAASi=renin-angiotensin-aldosterone system inhibitor; RRR=relative risk reduction; SGLT2i=sodium glucose cotransporter 2 inhibitor; T1D=type 1 diabetes; T2D=type 2 diabetes; uACR=urinary albumin-to-creatinine ratio.

References

  1. Herrington WG, Staplin N, Wanner C, et al; EMPA-KIDNEY Collaborative Group. Empagliflozin in patients with chronic kidney disease. N Engl J Med. 2023;388:117-127.

  2. EMPA-KIDNEY Collaborative Group. Design, recruitment and baseline characteristics of the EMPA-KIDNEY trial. Nephrol Dial Transplant. 2022;37:1317-1329. (EMPA-KIDNEY trial design and the publication's Supplementary Appendix).

  3. Eli Lilly and Co. Landmark EMPA-KIDNEY trial showed a significant benefit of Jardiance* in reducing kidney disease progression or cardiovascular death by 28% vs placebo in people with chronic kidney disease [News release]. November 4, 2022. Accessed December 12, 2022. https://investor.lilly.com/node/47876.pdf.