drugset / Trial / NCT03594110
EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
Phase 3
Completed
6609 enrolled
Boehringer Ingelheim
Eli Lilly and Company · collabUniversity of Oxford · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease. After completion of the interventional part of the study (primary study completion) a subset of participants will be followed up in a post-trial observational (non-interventional) manner for cardio-renal outcomes (estimated study completion date).
Timeline
- Start
- 2019-01-31
- Primary completion
- 2022-07-05
- Completion
- 2024-07-02
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Empagliflozin 10 mg; p <0.0001; Hazard Ratio (HR) 0.72 (99.83% CI 0.59 to 0.89); Regression, Cox NCT03594110 ↗
paper During the combined active- and post-trial periods, a primary-outcome event occurred in 865 of 3304 patients (26.2%) in the empagliflozin group and in 1001 of 3305 patients (30.3%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.72 to 0.87). PMID 39453837 ↗
release “EMPA-KIDNEY phase III clinical trial met its primary endpoint by demonstrating a significant kidney and cardiovascular benefit for adults living with chronic kidney disease (CKD).” lilly.com ↗
release “In EMPA-KIDNEY, Jardiance demonstrated a 28% relative risk reduction (absolute risk reduction 3.6% per patient-year at risk, HR=0.72; 95% CI 0.64 to 0.82; P<0.0001)” lilly.com ↗
Publications
- Mottl A, Scott C, Green JB, Heerspink HJL, Mann JFE, McGill JB, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Vaduganathan M, Agarwal R; CONFIDENCE Trial Investigators. Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial. J Am Soc Nephrol. 2026 Apr 1;37(4):764-776. doi: 10.1681/ASN.0000000928. Epub 2025 Nov 6.
- Uster A, Desai N, Navaneethan SD, Pfarr E, Mazo AR. Empagliflozin Reduces Risk of Hospitalization in Patients With Chronic Kidney Disease in the EMPA-KIDNEY Trial. Clin Ther. 2025 Dec;47(12):1091-1096. doi: 10.1016/j.clinthera.2025.09.005. Epub 2025 Oct 4.
- Zhou J, Williams C, Staplin N, Judge PK, Mayne KJ, Agrawal N, Arimoto R, Green JB, Cherney DZI, Tuttle KR, Leal J, Clarke P, Emberson JR, Preiss D, Wanner C, Landray MJ, Baigent C, Haynes R, Herrington WG, Mihaylova B; EMPA-KIDNEY Collaborative Group. Effects of empagliflozin on quality of life and healthcare use and costs in chronic kidney disease: a health economic analysis of the EMPA-KIDNEY trial. EClinicalMedicine. 2025 Jul 8;85:103338. doi: 10.1016/j.eclinm.2025.103338. eCollection 2025 Jul.
- Oshima M, Buizen L, Jongs N, Levin A, Chertow GM, Wheeler DC, Heerspink HJL, Arnott C, Jardine MJ, Mahaffey KW, Pollock C, Herrington WG, Perkovic V, Neuen BL. Sodium-Glucose Cotransporter 2 Inhibition and Hospitalizations in Patients with CKD: A Meta-Analysis of Kidney Outcome Trials. Clin J Am Soc Nephrol. 2025 Jul 14;20(9):1206-1214. doi: 10.2215/CJN.0000000771.
- Mayne KJ, Sardell RJ, Staplin N, Judge PK, Zhu D, Sammons E, Cherney DZI, Cheung AK, Maggioni AP, Nangaku M, Rossello X, Tuttle KR, Ihara K, Iwata T, Wanner C, Emberson J, Preiss D, Landray MJ, Baigent C, Haynes R, Herrington WG; EMPA-KIDNEY Collaborative Group. Frailty, Multimorbidity, and Polypharmacy: Exploratory Analyses of the Effects of Empagliflozin from the EMPA-KIDNEY Trial. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1119-1129. doi: 10.2215/CJN.0000000000000498. Epub 2024 Jun 27.
- EMPA-KIDNEY Collaborative Group; Herrington WG, Staplin N, Agrawal N, Wanner C, Green JB, Hauske SJ, Emberson JR, Preiss D, Judge P, Zhu D, Dayanandan R, Arimoto R, Mayne KJ, Ng SYA, Sammons E, Hill M, Stevens W, Wallendszus K, Brenner S, Cheung AK, Liu ZH, Li J, Hooi LS, Liu W, Kadowaki T, Nangaku M, Levin A, Cherney DZI, Maggioni AP, Pontremoli R, Deo R, Goto S, Rossello X, Tuttle KR, Steubl D, Massey D, Brueckmann M, Landray MJ, Baigent C, Haynes R; EMPA-KIDNEY Collaborative Group. Long-Term Effects of Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2025 Feb 20;392(8):777-787. doi: 10.1056/NEJMoa2409183. Epub 2024 Oct 25.
- Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
- Fletcher RA, Herrington WG, Agarwal R, Mayne KJ, Arnott C, Jardine MJ, Mahaffey KW, Perkovic V, Staplin N, Wheeler DC, Chertow GM, Heerspink HJL, Neuen BL. Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Cause-Specific Cardiovascular Death in Patients with CKD: A Meta-Analysis of CKD Progression Trials. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1180-1182. doi: 10.2215/CJN.0000000000000470. Epub 2024 Apr 16.
- Mayne KJ, Staplin N, Keane DF, Wanner C, Brenner S, Cejka V, Stegbauer J, Judge PK, Preiss D, Emberson J, Trinca D, Dayanandan R, Lee R, Nolan J, Omata A, Green JB, Cherney DZI, Hooi LS, Pontremoli R, Tuttle KR, Lees JS, Mark PB, Davies SJ, Hauske SJ, Steubl D, Bruckmann M, Landray MJ, Baigent C, Haynes R, Herrington WG; EMPA-KIDNEY Collaborative Group. Effects of Empagliflozin on Fluid Overload, Weight, and Blood Pressure in CKD. J Am Soc Nephrol. 2024 Feb 1;35(2):202-215. doi: 10.1681/ASN.0000000000000271. Epub 2023 Dec 12.
- EMPA-KIDNEY Collaborative Group. Impact of primary kidney disease on the effects of empagliflozin in patients with chronic kidney disease: secondary analyses of the EMPA-KIDNEY trial. Lancet Diabetes Endocrinol. 2024 Jan;12(1):51-60. doi: 10.1016/S2213-8587(23)00322-4. Epub 2023 Dec 4.
- EMPA-KIDNEY Collaborative Group. Effects of empagliflozin on progression of chronic kidney disease: a prespecified secondary analysis from the empa-kidney trial. Lancet Diabetes Endocrinol. 2024 Jan;12(1):39-50. doi: 10.1016/S2213-8587(23)00321-2. Epub 2023 Dec 4.
- The EMPA-KIDNEY Collaborative Group; Herrington WG, Staplin N, Wanner C, Green JB, Hauske SJ, Emberson JR, Preiss D, Judge P, Mayne KJ, Ng SYA, Sammons E, Zhu D, Hill M, Stevens W, Wallendszus K, Brenner S, Cheung AK, Liu ZH, Li J, Hooi LS, Liu W, Kadowaki T, Nangaku M, Levin A, Cherney D, Maggioni AP, Pontremoli R, Deo R, Goto S, Rossello X, Tuttle KR, Steubl D, Petrini M, Massey D, Eilbracht J, Brueckmann M, Landray MJ, Baigent C, Haynes R. Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2023 Jan 12;388(2):117-127. doi: 10.1056/NEJMoa2204233. Epub 2022 Nov 4.
- Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
- Almaimani M, Sridhar VS, Cherney DZI. Sodium-glucose cotransporter 2 inhibition in non-diabetic kidney disease. Curr Opin Nephrol Hypertens. 2021 Sep 1;30(5):474-481. doi: 10.1097/MNH.0000000000000724.
- Piperidou A, Loutradis C, Sarafidis P. SGLT-2 inhibitors and nephroprotection: current evidence and future perspectives. J Hum Hypertens. 2021 Jan;35(1):12-25. doi: 10.1038/s41371-020-00393-4. Epub 2020 Aug 10.
- Gonzalez DE, Foresto RD, Ribeiro AB. SGLT-2 inhibitors in diabetes: a focus on renoprotection. Rev Assoc Med Bras (1992). 2020 Jan 13;66Suppl 1(Suppl 1):s17-s24. doi: 10.1590/1806-9282.66.S1.17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 10 mg | Oral |