Phase 3
Completed N=6,609
EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
Source: ClinicalTrials.gov NCT03594110 ↗Enrolled (actual)
6,609
Serious AEs
34.1%
Results posted
Jul 2023
Primary outcomePrimary: Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') — 8.96; 6.85 patients with events/100 pt-yrs at risk — p=<0.0001
◆ Published Evidence
Established
25citations · ~13 / year
Frailty, Multimorbidity, and Polypharmacy: Exploratory Analyses of the Effects of Empagliflozin from the EMPA-KIDNEY Trial.
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).
Linked Publications (5)
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Frailty, Multimorbidity, and Polypharmacy: Exploratory Analyses of the Effects of Empagliflozin from the EMPA-KIDNEY Trial.
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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.
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Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial.
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Empagliflozin Reduces Risk of Hospitalization in Patients With Chronic Kidney Disease in the EMPA-KIDNEY Trial.
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Sodium-Glucose Cotransporter 2 Inhibition and Hospitalizations in Patients with CKD: A Meta-Analysis of Kidney Outcome Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') |
8.96; 6.85 | <0.0001 sig |
| PRIMARY Overall Study: Time to the First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') |
9.99; 8.36 | — |
| SECONDARY Key Secondary Endpoint: Interventional Part - Time to First Hospitalization for Heart Failure ('as Adjudicated') or Cardiovascular Death ('as Adjudicated') |
2.39; 2.04 | 0.1363 |
| SECONDARY Key Secondary Endpoint: Interventional Part - Time to Occurrences of All-cause Hospitalizations (First and Recurrent Combined) |
1895; 1612 | 0.0022 sig |
| SECONDARY Key Secondary Endpoint: Interventional Part - Time to Death From Any Cause ('as Adjudicated') |
2.59; 2.29 | 0.2122 |
| SECONDARY Interventional Part: Time to First Occurrence of Kidney Disease Progression |
8.09; 6.09 | <0.0001 sig |
| SECONDARY Interventional Part: Time to Cardiovascular Death ('as Adjudicated') |
1.08; 0.91 | 0.2932 |
| SECONDARY Interventional Part: Time to First Occurrence Cardiovascular Death ('as Adjudicated') or End Stage Kidney Disease (ESKD) |
3.45; 2.55 | 0.0017 sig |
| SECONDARY Overall Study: Time to First Occurrence of Kidney Disease Progression |
8.95; 7.52 | — |
| SECONDARY Overall Study: Time to First Occurrence of Death From Any Cause or ESKD |
6.08; 5.13 | — |
| SECONDARY Overall Study: Time to First Occurrence of ESKD |
3.49; 2.72 | — |
| SECONDARY Body Composition Measurement Sub-study: Mean Absolute Fluid Overload, Averaged Over Time |
0.34; 0.10 | < 0.001 sig |
| SECONDARY Magnetic Resonance Imaging Sub-study: Kidney Cortical T1 Mapping as Measured by Modified Look-Locker Inversion Recovery (MOLLI) at 18 Months |
1634; 1622 | 0.41 |
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years or at "full age" as required by local regulation
- Evidence of chronic kidney disease at risk of kidney disease progression defined by at least 3 months before and at the time of Screening Visit
- CKD-EPI eGFR ≥20 to 60 mL/min/1.73m2 at Screening
- Receiving combined ACEi and ARB treatment
- Maintenance dialysis, functioning kidney transplant, or scheduled living donor transplant
- Polycystic kidney disease
- Previous or scheduled bariatric surgery
- Ketoacidosis in the past 5 years
- Symptomatic hypotension, or systolic blood pressure 180 mmHg at Screening
- ALT or AST >3x ULN at Screening
- Hypersensitivity to empagliflozin or other SGLT-2 inhibitor
- Any intravenous immunosuppression therapy in last 3 months; or anyone currently on >45 mg prednisolone (or equivalent)
- Use of an investigational medicinal product in the 30 days prior to Screening visit
- Known to be poorly compliant with clinic visits or prescribed medication
- Medical history that might limit the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease; history of cancer or evidence of spread within last 4 years, other than non-melanoma skin cancer; or recent history of alcohol or substance misuse)
- Current pregnancy, lactation or women of childbearing potential (WOCBP), unless using highly-effective contraception
- Type 1 diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT03594110) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.