Evaluating the Short-Term Renal and Systemic Effects of SGLT2 Inhibition in Non-Diabetic Patients at Risk of Accelerated GFR Decline Because of Glomerular Hyperfiltration: a sequential OFF-ON-OFF Study with One-Month Empagliflozin Therapy Followed by One-Month Recovery Period - SGLT2 inhibitors in glomerular hyperfiltration

IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI0 sites0 target enrollmentJune 17, 2021

Overview

No summary available.

Registry

who.int

Start Date

June 17, 2021

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

•\- Male and female \= 18 years old;
•\- Increased risk of accelerated renal function loss because of absolute or relative hyperfiltration associated with unhealthy (abdominal) obesity or residual proteinuria defined as:
•Unhealthy obesity:
•\- Waist circumference \=94 cm in males and \= 80 cm in females
•Metabolic syndrome, defined as the presence of at least three of the following criteria:
•\- Blood pressure\>140/90 mmHg or controlled blood pressure under current antihypertensive treatment
•\- Triglyceride levels \>150 mg/dL
•\- HDL\<40 mg/dL in males \<50 mg/dL in females
•\- Fasting blood glucose \> 100 mg/dL
•Residual proteinuria:

•Exclusion Criteria
•1\. Type 1or 2 diabetic patients;
•2\. Fasting blood glucose \> 125 mg/dl and/or concomitant treatment with insulin or oral hypoglycemic agents;
•3\. Estimated GFR \= 60 ml/min/1\.73m2 (CKD\-EPI formula);
•4\. Reversible causes of transient increases of proteinuria including infection, fever, strenuous physical exercise
•5\. Nephrotic syndrome of any etiology;
•6\. Patients with Autosomal Dominant Polycystic Kidney Disease;
•7\. Symptomatic urinary tract lithiasis or obstruction;
•8\. Ischemic kidney disease (because of possible excess risk of acute kidney injury upon SGLT2 inhibition associated reduction in sodium pool and kidney perfusion pressure);
•9\. Rapidly progressive kidney disease defined by impairment of renal function within 2 weeks – 3 months (for the cohort of patients with residual proteinuria only) ;