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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 : October 16, 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

Tracking Information
First Submitted Date  ICMJE July 10, 2018
First Posted Date  ICMJE July 20, 2018
Last Update Posted Date October 16, 2019
Actual Study Start Date  ICMJE January 31, 2019
Estimated Primary Completion Date June 2, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03594110 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • Time to first hospitalization for heart failure or cardiovascular death [ Time Frame: Median follow-up approx. 3.1 years ]
  • Occurrences of all-cause hospitalization (first and recurrent) [ Time Frame: Median follow-up approx. 3.1 years ]
  • Time to death from any cause [ Time Frame: Median follow-up approx. 3.1 years ]
  • Time to first occurrence of kidney disease progression [ Time Frame: Median follow-up approx. 3.1 years ]
  • Time to cardiovascular death [ Time Frame: Median follow-up approx. 3.1 years ]
  • Time to cardiovascular death or ESKD [ Time Frame: Median follow-up approx. 3.1 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE
  • Drug: Empagliflozin
    Taken daily with or without food
  • Drug: Matching placebo
    Taken daily with or without food
Study Arms  ICMJE
  • Experimental: Empagliflozin
    Intervention: Drug: Empagliflozin
  • Placebo Comparator: Placebo
    Intervention: Drug: Matching placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2018)
5000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 2, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Canada,   Germany,   Japan,   Malaysia,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03594110
Other Study ID Numbers  ICMJE 1245-0137
2017-002971-24 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE
  • Medical Research Council Population Health Research Unit, CTSU, University of Oxford (academic lead)
  • Eli Lilly and Company
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP