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Clinical Trial Details

Trial ID: L1075
Source ID: NCT04143581
Associated Drug: Empagliflozin 10 Mg
Title: SGLT2 Inhibitors in Glomerular Hyperfiltration
Acronym: EMPATHY
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Obesity|Non-diabetic Chronic Kidney Disease
Interventions: DRUG: Empagliflozin 10 MG
Outcome Measures: Primary: Measured Glomerular Filtration Rate (GFR), GFR will be measured by the iohexol plasma clearance technique, Changes from baseline to the end of one-month treatment period and one-month recovery period | Secondary: 24 hour urinary output, last of three consecutive collections, Changes from baseline to the end of one-month treatment period and one-month recovery period|24 hour urinary protein excretion, mean of the measurement in three consecutive 24-hour urine collection, Changes from baseline to the end of one-month treatment period and one-month recovery period|24 hour urinary albumin excretion, mean of the measurement in three consecutive 24-hour urine collection, Changes from baseline to the end of one-month treatment period and one-month recovery period|24 hour urinary urea excretion, last of three consecutive collections, Changes from baseline to the end of one-month treatment period and one-month recovery period|24 hour urinary phosphate excretion, last of three consecutive collections, Changes from baseline to the end of one-month treatment period and one-month recovery period|24 hour urinary sodium excretion, last of three consecutive collections, Changes from baseline to the end of one-month treatment period and one-month recovery period|24 hour urinary glucose excretion, last of three consecutive collections, Changes from baseline to the end of one-month treatment period and one-month recovery period|24 hour urinary potassium excretion, last of three consecutive collections, Changes from baseline to the end of one-month treatment period and one-month recovery period|24 hour urinary uric acid excretion, last of three consecutive collections, Changes from baseline to the end of one-month treatment period and one-month recovery period|24 hour urinary creatinine excretion, last of three consecutive collections, Changes from baseline to the end of one-month treatment period and one-month recovery period|Fractional clearance of total protein calculated by standard formulas, Changes from baseline to the end of one-month treatment period and one-month recovery period|Fractional clearance of albumin calculated by standard formulas, Changes from baseline to the end of one-month treatment period and one-month recovery period|Fractional clearance of sodium calculated by standard formulas, Changes from baseline to the end of one-month treatment period and one-month recovery period|Fractional clearance of potassium calculated by standard formulas, Changes from baseline to the end of one-month treatment period and one-month recovery period|Fractional clearance of uric acid calculated by standard formulas, Changes from baseline to the end of one-month treatment period and one-month recovery period|Fractional clearance of free water calculated by standard formulas, Changes from baseline to the end of one-month treatment period and one-month recovery period|Glucose disposal rate, Performed by hyperinsulinemic euglycemic clamp and by standard oral glucose load and HOMA index;, Changes from baseline to the end of one-month treatment period and one-month recovery period|Glucose tolerance, Performed by hyperinsulinemic euglycemic clamp and by standard oral glucose load and HOMA index;, Changes from baseline to the end of one-month treatment period and one-month recovery period|Office blood pressure, Changes from baseline to the end of one-month treatment period and one-month recovery period|Office heart rate, Changes from baseline to the end of one-month treatment period and one-month recovery period|24 hour (day-time and night-time) blood pressure monitoring, Changes from baseline to the end of one-month treatment period and one-month recovery period|24 hour (day-time and night-time) heart rate monitoring, Changes from baseline to the end of one-month treatment period and one-month recovery period|Pulse wave velocity, These parameters will be measured by tonometry, Changes from baseline to the end of one-month treatment period and one-month recovery period|other marker of vascular stiffness, These parameters will be measured by tonometry, Changes from baseline to the end of one-month treatment period and one-month recovery period|Indices of Quality of Life: questionnaire SF-36, By submission of validate questionnaire, Changes from baseline to the end of one-month treatment period and one-month recovery period
Sponsor/Collaborators: Sponsor: Mario Negri Institute for Pharmacological Research | Collaborators: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-09-03
Completion Date: 2021-09-03
Results First Posted:
Last Update Posted: 2021-09-13
Locations:
URL: https://clinicaltrials.gov/show/NCT04143581