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Clinical Trial Details

Trial ID: L0643
Source ID: NCT03078101
Associated Drug: Empagliflozin 10 Mg [Jardiance]
Title: EMPRA (EMPagliflozin and RAs in Kidney Disease)
Acronym: EMPRA
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetic Kidney Disease|Diabetes Mellitus, Type 2|Chronic Kidney Disease stage3|Chronic Kidney Disease stage4
Interventions: DRUG: Empagliflozin 10 MG [Jardiance]|DRUG: Placebo Oral Tablet
Outcome Measures: Primary: The difference of Ang 1-7 increase from baseline between a 3-month treatment with empagliflozin on top of ACEi treatment compared to ACEi treatment alone, The difference of Ang 1-7 increase from baseline between a 3-month treatment with empagliflozin on top of ACEi treatment compared to ACEi treatment alone, Visit 2 and Visit 8; 3 months | Secondary: Mean quantitative changes of baseline multiple RAS effector angiotensin levels after 3 months of empagaliflozin treatment, Mean quantitative changes of baseline multiple RAS effector angiotensin levels after 3 months of empagaliflozin treatment, Visit 2 and Visit 8; 3 months|Mean changes of baseline Ang II levels after 3 months of empagaliflozin treatment, Mean changes of baseline Ang II levels after 3 months of empagaliflozin treatment, Visit 2 and Visit 8; : 3 months|Mean changes of baseline specific protein amount on HDL after 3 months of empagaliflozin treatment, Mean changes of baseline specific protein amount on HDL after 3 months of empagaliflozin treatment, Visit 2 and Visit 8; 3 months|Mean changes in specific renal parameters from baseline in 3 months of empagaliflozin treatment (albuminuria reduction, renal function), Mean changes in specific renal parameters from baseline in 3 months of empagaliflozin treatment (albuminuria reduction, renal function), Visit 2 ,3,4,5,6,7,8; 3 months|Mean changes from baseline relevant blood parameters (HbA1c, β-hydroxybutyrat, elektrolytes, lipids, etc.) after 3 months of empagaliflozin treatment, Mean changes from baseline relevant blood parameters (HbA1c, β-hydroxybutyrat, elektrolytes, lipids, etc.) after 3 months of empagaliflozin treatment, Visit 2 ,3,4,5,6,7,8; 3 months|Mean changes from baseline urinary RAS metabolites (angiotensinogen, ACE and ACE2 levels, ACE2 activity) after 3 months of empagaliflozin treatment, Mean changes from baseline urinary RAS metabolites (angiotensinogen, ACE and ACE2 levels, ACE2 activity) after 3 months of empagaliflozin treatment, Visit 2 and Visit 8; 3 months|Mean changes in baseline blood pressure after 3 months of empagaliflozin treatment, Mean changes in baseline blood pressure after 3 months of empagaliflozin treatment, Visit 2 ,3,4,5,6,7,8; 3 months|Mean changes in body fluid status after 3 months of empagaliflozin treatment, Mean changes in body fluid status after 3 months of empagaliflozin treatment, Visit 2 and Visit 8; 3 months|Mean changes in baseline oxygen consumption rate (OCR) and the extracellular acidification rate (ECAR) in peripheral peripheral blood mononuclear cells (PBMCs) after 3 months of empagliflozin treatment, Mean changes in baseline oxygen consumption rate (OCR) and the extracellular acidification rate (ECAR) in peripheral peripheral blood mononuclear cells (PBMCs) after 3 months of empagliflozin treatment, Visit 2 and Visit 8; 3 months|Mean changes in salt sensitivity after 3 months of empagliflozin treatment, Mean changes in salt sensitivity after 3 months of empagliflozin treatment, Visit 2 and Visit 8; 3 months | Other: Number of symptomatic hypoglycemia and confirmed hypoglycemic events (plasma glucose level ≤70 mg/dl or an event requiring assistance), Number of symptomatic hypoglycemia and confirmed hypoglycemic events (plasma glucose level ≤70 mg/dl or an event requiring assistance), Visit 2 ,3,4,5,6,7,8; timeframe: 3 months|Number of adverse events reflecting urinary tract infections, genital infections, volume depletion, acute renal failure, bone fractures, diabetic ketoacidosis and thromboembolic events., Number of adverse events reflecting urinary tract infections, genital infections, volume depletion, acute renal failure, bone fractures, diabetic ketoacidosis and thromboembolic events., Visit 2 ,3,4,5,6,7,8; 3 months|Number of cardiovascular events (i.e. stroke, myocardial infarction, heart failure) during the study., Number of cardiovascular events (i.e. stroke, myocardial infarction, heart failure) during the study., Visit 2 ,3,4,5,6,7,8; 3 months|Number of hospitalizations during the study., Number of hospitalizations during the study., Visit 2 ,3,4,5,6,7,8; 3 months
Sponsor/Collaborators: Sponsor: Medical University of Vienna | Collaborators: Attoquant Diagnostics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 51
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-04-15
Completion Date: 2019-08-07
Results First Posted:
Last Update Posted: 2019-08-08
Locations: Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria, Vienna, 1090, Austria
URL: https://clinicaltrials.gov/show/NCT03078101