Trial · NCT03594110
EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
NCT03594110, Phase 3, Completed, Boehringer Ingelheim; results first posted 2023-07-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin). Trials, record NCT03594110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03594110
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
- NCT number
- NCT03594110
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 6,609 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Chronic Kidney Disease
- Interventions
- Empagliflozin, Matching placebo
- First posted
- 2018-07-20
- Last updated
- 2025-07-20
- Other registries' IDs
- eudract:2017-002971-24
- Results first posted
- 2023-07-27
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') | From the day of randomisation to the day of the final follow-up visit in the interventional part of the trial, up to 1136 days. | Time to first occurrence of kidney disease progression (KDP) or cardiovascular death is reported as incidence rate of first occurrence of KDP or adjudicated cardiovascular death. Incidence rate= (Number of patients who experienced the event of first occurrence of KDP or cardiovascular death)\*100/(patient years at risk (pt-yrs at risk). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. Kidney disease progression was defined as: * end stage kidney disease (defined as the initiation of maintenance dialysis or receipt of a kidney transplant) OR * a sustained decline in estimated glomerular filtration rate (eGFR) to \<10 mL/min/1.73m\^2 OR * renal death OR * a sustained decline of ≥40% in eGFR from randomisation. |
| Primary | Overall Study: Time to the First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') | From the day of randomization in the interventional part of the trial until the individual day of end of study in the non-interventional part of the trial. Up to 1869 days. | Time to first occurrence of kidney disease progression (KDP) or cardiovascular death is reported as incidence of progression of kidney disease or death from cardiovascular causes in the interventional part of the trial and in the post-trial follow-up (non-interventional part). Incidence rate= (Number of patients who experienced the event of first occurrence of KDP or cardiovascular death)\*100/(patient years at risk (pt-yrs at risk). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. Kidney disease progression was defined as: * a sustained decline in eGFR to less than 10 mL/min/1.73m\^2 OR * renal death OR * sustained decline of more than 40% in eGFR from randomization. |
| Secondary | Key Secondary Endpoint: Interventional Part - Time to First Hospitalization for Heart Failure ('as Adjudicated') or Cardiovascular Death ('as Adjudicated') | From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days. | Time to first hospitalization for heart failure ('as adjudicated') or cardiovascular death ('as adjudicated') is reported as incidence rate of first hospitalization for heart failure or cardiovascular death. Incidence rate= (Number of patients who experienced the event of first hospitalization for heart failure or cardiovascular death) \*100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. |
| Secondary | Key Secondary Endpoint: Interventional Part - Time to Occurrences of All-cause Hospitalizations (First and Recurrent Combined) | From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days. | Time to occurrences of all-cause hospitalizations is reported as total number of all-cause hospitalizations (first and recurrent combined). |
| Secondary | Key Secondary Endpoint: Interventional Part - Time to Death From Any Cause ('as Adjudicated') | From the day of randomisation to the day of the final follow-up visit in the interventional part of the trial, up to 1140 days. | Time to death from any cause is reported as incidence rate of death from any cause. Incidence rate of death from any cause = (Number of patients who experienced the event of death from any cause) \* 100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. |
| Secondary | Interventional Part: Time to First Occurrence of Kidney Disease Progression | From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1136 days. | Time to first occurrence of kidney disease progression (KDP) is reported as incidence rate of first occurrence of kidney disease progression. Incidence rate of first occurrence of kidney disease progression= (Number of patients who experienced the event of first occurrence of kidney disease progression) \*100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. Kidney disease progression was defined as: * end stage kidney disease (defined as the initiation of maintenance dialysis or receipt of a kidney transplant) OR * a sustained decline in estimated glomerular filtration rate (eGFR) to \<10 mL/min/1.73m\^2 OR * renal death OR * a sustained decline of ≥40% in eGFR from randomisation). |
| Secondary | Interventional Part: Time to Cardiovascular Death ('as Adjudicated') | From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days. | Time to cardiovascular death ('as adjudicated') is reported as incidence rate of cardiovascular death. Incidence rate of cardiovascular death= (Number of patients who experienced the event of cardiovascular death) \*100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. |
| Secondary | Interventional Part: Time to First Occurrence Cardiovascular Death ('as Adjudicated') or End Stage Kidney Disease (ESKD) | From the day of randomization to the day of the final follow-up visit in the interventional part of the trial, up to 1140 days. | Time to first occurrence of cardiovascular death ('as adjudicated') or end stage kidney disease is reported as incidence rate of first occurrence of cardiovascular death or end stage kidney disease (ESKD). Incidence rate of first occurrence cardiovascular death or end stage kidney disease (ESKD)= (Number of patients who experienced the event of first occurrence of cardiovascular death or end stage kidney disease (ESKD)) \*100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. ESKD was defined as the initiation of maintenance dialysis or receipt of a kidney transplant. |
| Secondary | Overall Study: Time to First Occurrence of Kidney Disease Progression | From the day of randomization in the interventional part of the trial until the individual day of end of study in the non-interventional part of the trial. Up to 1869 days. | The time to first occurrence of kidney disease progression in the interventional part of the trial and in the post-trial follow-up (non-interventional part) is reported as the incidence rate of first occurrence of kidney disease progression. Incidence rate of first occurrence of kidney disease progression= (Number of patients who experienced the event of first occurrence of kidney disease progression) \*100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. Kidney disease progression was defined as: * end stage kidney disease (defined as the initiation of maintenance dialysis or receipt of a kidney transplant) OR * a sustained decline in estimated glomerular filtration rate (eGFR) to \<10 mL/min/1.73m\^2 OR * renal death OR * a sustained decline of ≥40% in eGFR from randomisation. |
| Secondary | Overall Study: Time to First Occurrence of Death From Any Cause or ESKD | From the day of randomization in the interventional part of the trial until the individual day of end of study in the non-interventional part of the trial. Up to 1869 days. | Time to first occurrence of death from any cause or end stage kidney disease (ESKD) in the interventional part of the trial and in the post-trial follow-up (non-interventional part) is reported as incidence rate of first occurrence of death from any cause or ESKD. Incidence rate of first occurrence of death from any cause or end stage kidney disease (ESKD)= (Number of patients who experienced the event of first occurrence of death any cause or end stage kidney disease (ESKD)) \*100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. ESKD was defined as the initiation of maintenance dialysis or receipt of a kidney transplant. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') | From the day of randomisation to the day of the final follow-up visit in the interventional part of the trial, up to 1136 days. | Randomised set (RS) included all randomised participants, whether treated or not. | patients with events/100 pt-yrs at risk | NUMBER |
| SECONDARY | Key Secondary Endpoint: Interventional Part - Time to First Hospitalization for Heart Failure ('as Adjudicated') or Cardiovascular Death ('as Adjudicated') | From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days. | Randomised set (RS) included all randomised participants, whether treated or not. | patients with events/100 pt-yrs at risk | NUMBER |
| SECONDARY | Key Secondary Endpoint: Interventional Part - Time to Occurrences of All-cause Hospitalizations (First and Recurrent Combined) | From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days. | Randomised set (RS) included all randomised participants, whether treated or not. | events (first and recurrent) | NUMBER |
| SECONDARY | Key Secondary Endpoint: Interventional Part - Time to Death From Any Cause ('as Adjudicated') | From the day of randomisation to the day of the final follow-up visit in the interventional part of the trial, up to 1140 days. | Randomised set (RS) included all randomised participants, whether treated or not. | patients with events/100 pt-yrs at risk | NUMBER |
| SECONDARY | Interventional Part: Time to First Occurrence of Kidney Disease Progression | From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1136 days. | Randomised set (RS) included all randomised participants, whether treated or not. | patients with events/100 pt-yrs at risk | NUMBER |
| SECONDARY | Interventional Part: Time to Cardiovascular Death ('as Adjudicated') | From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days. | Randomised set (RS) included all randomised participants, whether treated or not. | patients with events/100 pt-yrs at risk | NUMBER |
| SECONDARY | Interventional Part: Time to First Occurrence Cardiovascular Death ('as Adjudicated') or End Stage Kidney Disease (ESKD) | From the day of randomization to the day of the final follow-up visit in the interventional part of the trial, up to 1140 days. | Randomised set (RS) included all randomised participants, whether treated or not. | patients with events/100 pt-yrs at risk | NUMBER |
| PRIMARY | Overall Study: Time to the First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') | From the day of randomization in the interventional part of the trial until the individual day of end of study in the non-interventional part of the trial. Up to 1869 days. | Randomised set (RS): included all randomised participants, whether treated or not. | patients with events/100 pt-yrs at risk | NUMBER |
| SECONDARY | Overall Study: Time to First Occurrence of Kidney Disease Progression | From the day of randomization in the interventional part of the trial until the individual day of end of study in the non-interventional part of the trial. Up to 1869 days. | Randomised set (RS) included all randomised participants, whether treated or not. | patients with events/100 pt-yrs at risk | NUMBER |
| SECONDARY | Overall Study: Time to First Occurrence of Death From Any Cause or ESKD | From the day of randomization in the interventional part of the trial until the individual day of end of study in the non-interventional part of the trial. Up to 1869 days. | Randomised set (RS) included all randomised participants, whether treated or not. | patients with events/100 pt-yrs at risk | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') | Placebo | 8.96 | 95% Confidence Interval 8.23 to 9.72 | patients with events/100 pt-yrs at risk | |
| Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') | Empagliflozin 10 mg | 6.85 | 95% Confidence Interval 6.22 to 7.51 | patients with events/100 pt-yrs at risk | |
| Key Secondary Endpoint: Interventional Part - Time to First Hospitalization for Heart Failure ('as Adjudicated') or Cardiovascular Death ('as Adjudicated') | Placebo | 2.39 | 95% Confidence Interval 2.03 to 2.78 | patients with events/100 pt-yrs at risk | |
| Key Secondary Endpoint: Interventional Part - Time to First Hospitalization for Heart Failure ('as Adjudicated') or Cardiovascular Death ('as Adjudicated') | Empagliflozin 10 mg | 2.04 | 95% Confidence Interval 1.70 to 2.40 | patients with events/100 pt-yrs at risk | |
| Key Secondary Endpoint: Interventional Part - Time to Occurrences of All-cause Hospitalizations (First and Recurrent Combined) | Placebo | 1895 | events (first and recurrent) | ||
| Key Secondary Endpoint: Interventional Part - Time to Occurrences of All-cause Hospitalizations (First and Recurrent Combined) | Empagliflozin 10 mg | 1612 | events (first and recurrent) | ||
| Key Secondary Endpoint: Interventional Part - Time to Death From Any Cause ('as Adjudicated') | Placebo | 2.59 | 95% Confidence Interval 2.21 to 3.00 | patients with events/100 pt-yrs at risk | |
| Key Secondary Endpoint: Interventional Part - Time to Death From Any Cause ('as Adjudicated') | Empagliflozin 10 mg | 2.29 | 95% Confidence Interval 1.94 to 2.68 | patients with events/100 pt-yrs at risk | |
| Interventional Part: Time to First Occurrence of Kidney Disease Progression | Placebo | 8.09 | 95% Confidence Interval 7.40 to 8.81 | patients with events/100 pt-yrs at risk | |
| Interventional Part: Time to First Occurrence of Kidney Disease Progression | Empagliflozin 10 mg | 6.09 | 95% Confidence Interval 5.50 to 6.72 | patients with events/100 pt-yrs at risk |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Interventional Part | STARTED | Placebo | 3,305 | |
| Interventional Part | STARTED | Empagliflozin 10 mg | 3,304 | |
| Interventional Part | Treated | Placebo | 3,305 | |
| Interventional Part | Treated | Empagliflozin 10 mg | 3,304 | |
| Interventional Part | Body Composition Measurement (BCM) Sub-study | Placebo | 328 | |
| Interventional Part | Body Composition Measurement (BCM) Sub-study | Empagliflozin 10 mg | 332 | |
| Interventional Part | Magnetic Resonance Imaging (MRI) Sub-study | Placebo | 79 | |
| Interventional Part | Magnetic Resonance Imaging (MRI) Sub-study | Empagliflozin 10 mg | 93 | |
| Interventional Part | COMPLETED | Placebo | 2,457 | |
| Interventional Part | COMPLETED | Empagliflozin 10 mg | 2,549 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,748
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gout | Metabolism and nutrition disorders | Placebo | 262 | 3,305 | |
| other | Gout | Metabolism and nutrition disorders | Empagliflozin 10 mg | 228 | 3,304 | |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 10 | 3,305 | |
| serious | Anaemia | Blood and lymphatic system disorders | Empagliflozin 10 mg | 2 | 3,304 | |
| serious | Anaemia of chronic disease | Blood and lymphatic system disorders | Placebo | 1 | 3,305 | |
| serious | Anaemia of chronic disease | Blood and lymphatic system disorders | Empagliflozin 10 mg | 2 | 3,304 | |
| serious | Aplasia pure red cell | Blood and lymphatic system disorders | Placebo | 1 | 3,305 | |
| serious | Aplasia pure red cell | Blood and lymphatic system disorders | Empagliflozin 10 mg | 0 | 3,304 | |
| serious | Aplastic anaemia | Blood and lymphatic system disorders | Placebo | 1 | 3,305 | |
| serious | Aplastic anaemia | Blood and lymphatic system disorders | Empagliflozin 10 mg | 0 | 3,304 |
1 to 10 of 1,748Source ClinicalTrials.gov
See all 1,748 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 353 | 3,305 |
| Total, all-cause mortality | Empagliflozin 10 mg | 314 | 3,304 |
| Total, other adverse events | Placebo | 262 | 3,305 |
| Total, other adverse events | Empagliflozin 10 mg | 228 | 3,304 |
| Total, serious adverse events | Placebo | 1,167 | 3,305 |
| Total, serious adverse events | Empagliflozin 10 mg | 1,089 | 3,304 |
Source ClinicalTrials.gov
Papers17
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Empagliflozin 10 mg vs Placebo: deaths from any cause | Trial comparisons |
| Empagliflozin 10 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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