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

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ClinicalTrials.gov Identifier: NCT03594110
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 10, 2019
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 : 5000 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 : June 2, 2022
Estimated Study Completion Date : June 30, 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. Occurrences of all-cause hospitalization (first and recurrent) [ 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

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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
  • Neither requires an 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 disease with an eGFR >60 mL/min/1.73m² ;
  • Receiving dual RAS inhibition (two of ACEi, ARB, DRI);
  • Any immunosuppression therapy in last 3 months (except prednisolone ≤10 mg or equivalent); or anyone currently on >10 mg prednisolone (or equivalent)
  • 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 <90 or >180 mmHg;
  • ALT or AST >3x ULN;
  • Hypersensitivity to empagliflozin or other SGLT-2 inhibitor;
  • Known to be poorly compliant with clinic visits or prescribed medication

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

  Show 62 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Medical Research Council Population Health Research Unit, CTSU, University of Oxford (academic lead)
Eli Lilly and Company

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03594110     History of Changes
Other Study ID Numbers: 1245-0137
2017-002971-24 ( EudraCT Number )
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
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