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EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03594110
Recruitment Status : Active, not recruiting
First Posted : July 20, 2018
Results First Posted : July 27, 2023
Last Update Posted : March 7, 2024
Sponsor:
Collaborators:
Medical Research Council Population Health Research Unit, CTSU, University of Oxford (academic lead)
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Empagliflozin Drug: Matching placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6609 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre International Randomized Parallel Group Double-blind Placebo-controlled Clinical Trial of EMPAgliflozin Once Daily to Assess Cardio-renal Outcomes in Patients With Chronic KIDNEY Disease
Actual Study Start Date : January 31, 2019
Actual Primary Completion Date : July 5, 2022
Estimated Study Completion Date : July 5, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Empagliflozin 10 mg
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
 Drug: Empagliflozin
Taken daily with or without food
Placebo Comparator: Placebo
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
 Drug: Matching placebo
Taken daily with or without food


Outcome Measures
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Primary Outcome Measures :
  1. Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') [ Time Frame: Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1136 days. ]

    Incidence rate of first occurrence of kidney disease progression (KDP) or adjudicated cardiovascular death is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) was not estimable due to insufficient events being experienced.

    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.


Secondary Outcome Measures :
  1. Key Secondary Endpoint: Interventional Part - Time to First Hospitalization for Heart Failure ('as Adjudicated') or Cardiovascular Death ('as Adjudicated') [ Time Frame: Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days. ]

    Incidence rate of first hospitalization for heart failure or cardiovascular death is reported in the Outcome Measure Data Table because metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.

    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.


  2. Key Secondary Endpoint: Interventional Part - Time to Occurrences of All-cause Hospitalizations (First and Recurrent Combined) [ Time Frame: Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days. ]
    Total number of all-cause hospitalizations (first and recurrent combined) is reported in the Outcome Measure Data Table. Conventional time-to-event (TTE) metrics such as the median not calculable for a recurrent TTE analysis.

  3. Key Secondary Endpoint: Interventional Part - Time to Death From Any Cause ('as Adjudicated') [ Time Frame: Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days. ]

    Incidence rate of death from any cause is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.

    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.


  4. Interventional Part: Time to First Occurrence of Kidney Disease Progression [ Time Frame: Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1136 days. ]

    Incidence rate of first occurrence of kidney disease progression is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.

    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).

  5. Interventional Part: Time to Cardiovascular Death ('as Adjudicated') [ Time Frame: Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days. ]

    Incidence rate of first occurrence of kidney disease progression is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.

    Incidence rate of cardiovascular death is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to too few events being experienced.

    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.


  6. Interventional Part: Time to First Occurrence Cardiovascular Death ('as Adjudicated') or End Stage Kidney Disease (ESKD) [ Time Frame: Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days. ]

    Incidence rate of first occurrence of cardiovascular death or end stage kidney disease (ESKD) is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.

    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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <45 mL/min/1.73m² or
    • CKD-EPI eGFR ≥45 to <90 mL/min/1.73m² with urinary albumin:creatinine ratio ≥200 mg/g (or protein:creatinine ratio ≥300 mg/g);
  • Clinically appropriate doses of single agent RAS-inhibition with either ACEi or ARB unless such treatment is either not tolerated or not indicated
  • A local Investigator judges that the participant neither requires empagliflozin (or any other SGLT-2 or SGLT-1/2 inhibitor), nor that such treatment is inappropriate;

Key Exclusion Criteria:

  • Currently receiving SGLT-2 or SGLT-1/2 inhibitor
  • Diabetes mellitus type 2 and prior atherosclerotic cardiovascular diseasee with an eGFR >60 mL/min/1.73m2 at Screening
  • Receiving combined ACEi and ARBf 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 hypotensiond, or systolic blood pressure <90 or >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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594110


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Medical Research Council Population Health Research Unit, CTSU, University of Oxford (academic lead)
Eli Lilly and Company
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] January 13, 2020
Statistical Analysis Plan  [PDF] July 15, 2022

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03594110    
Other Study ID Numbers: 1245-0137
2017-002971-24 ( EudraCT Number )
First Posted: July 20, 2018    Key Record Dates
Results First Posted: July 27, 2023
Last Update Posted: March 7, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
URL: https://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency
 Chronic Disease
Disease Attributes
Pathologic Processes
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs