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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03594110
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : October 8, 2020
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

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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 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
Estimated Primary Completion Date : October 3, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Empagliflozin Drug: Empagliflozin
Taken daily with or without food

Placebo Comparator: Placebo Drug: Matching placebo
Taken daily with or without food




Primary Outcome Measures :
  1. Composite primary outcome:Time to first occurrence of (i) kidney disease progression (defined as ESKD, a sustained decline in eGFR to <10 mL/min/1.73m², renal death, or a sustained decline of ≥40% in eGFR from randomization) or (ii) Cardiovascular death [ Time Frame: Median follow-up approx. 3.1 years ]
    End Stage Kidney Disease (ESKD) is defined as the initiation of maintenance dialysis or receipt of a kidney transplant


Secondary Outcome Measures :
  1. Time to first hospitalization for heart failure or cardiovascular death [ Time Frame: Median follow-up approx. 3.1 years ]
  2. Time to occurrences of all-cause hospitalizations (first and recurrent combined) [ Time Frame: Median follow-up approx. 3.1 years ]
  3. Time to death from any cause [ Time Frame: Median follow-up approx. 3.1 years ]
  4. Time to first occurrence of kidney disease progression [ Time Frame: Median follow-up approx. 3.1 years ]
  5. Time to cardiovascular death [ Time Frame: Median follow-up approx. 3.1 years ]
  6. Time to cardiovascular death or ESKD [ Time Frame: Median follow-up approx. 3.1 years ]


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

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


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Contact: CTSU University of Oxford +44(0)1865743868 cco.empakidney@ndph.ox.ac.uk

Locations
Show Show 228 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Medical Research Council Population Health Research Unit, CTSU, University of Oxford (academic lead)
Eli Lilly and Company
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
Last Update Posted: October 8, 2020
Last Verified: October 2020
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:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html 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 http://trials.boehringeringelheim. com/ 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://trials.boehringer-ingelheim.com

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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
Renal Insufficiency
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs