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Kidney Week

Abstract: FR-OR68

Empagliflozin in Patients With CKD

Session Information

  • High-Impact Clinical Trials
    November 04, 2022 | Location: W415 Valencia, Orange County Convention Center‚ West Building
    Abstract Time: 12:15 PM - 12:30 PM

Category: CKD (Non-Dialysis)

  • 2202 CKD (Non-Dialysis): Clinical‚ Outcomes‚ and Trials

Authors

  • Herrington, William G., Medical Research Council Population Health Research Unit at the University of Oxford, Oxford, United Kingdom
  • Haynes, Richard, Medical Research Council Population Health Research Unit at the University of Oxford, Oxford, United Kingdom

Group or Team Name

  • On behalf of the EMPA-KIDNEY Collaborative Group
Background

More evidence is needed on the effects of sodium-glucose co-transporter-2 inhibition on renal and cardiovascular (CV) disease in patients with chronic kidney disease (CKD), in particular those without diabetes (DM), low estimated glomerular filtration rate (eGFR) or low albuminuria.

Methods

Between May 2019 and Apr 2021, 6609 participants were randomly allocated empagliflozin 10mg once daily or matching placebo. Eligible patients had an eGFR of 20 to <45 ml/min/1.73m2; or an eGFR of 45 to <90 ml/min/1.73m2 with a urinary albumin-to-creatinine ratio (uACR) of ≥200 mg/g and were receiving standard of care (including a renin angiotensin system inhibitor, where indicated and tolerated). The primary outcome is a composite of end-stage kidney disease (ESKD), a sustained eGFR <10 ml/min/1.73m2, a sustained decline in eGFR of ≥40%, or death from renal or CV causes. The main pre-specified subgroups are by DM status, eGFR and uACR. Key secondary outcomes are hospitalization for heart failure (HHF) or CV death; all-cause hospitalizations; and all-cause death.

Results

Mean eGFR was 37.5 mL/min/1.73m2 (SD 14.8), including 78% with an eGFR <45 mL/min/1.73m2. 48% had a uACR <300 mg/g and 54% had no history of DM. Final follow-up visits are complete and data are under analysis, but the Steering Committee remain blind to results. About 900 participants have had a primary outcome, including ~250 developing ESKD (with similar numbers of primary outcomes among patients with and without DM respectively). About 280 participants have experienced HHF or CV death, and ~310 have died.

Conclusion

EMPA-KIDNEY is the largest kidney disease progression trial to assess SGLT-2 inhibition in CKD. The trial was stopped early for benefit on the recommendation of the independent data monitoring committee and the unblinded results will be presented for the first time at ASN Kidney Week 2022.

Funding

  • Commercial Support