Effect of empagliflozin on the renin-angiotensin system in patients with chronic kidney disease with and without type 2 diabetes - EMPagliflozin and RAs in kidney disease

Medical University of Vienna, Internal Medicine III, Clinical Div. of Nephrology and Dialysis0 sites48 target enrollmentOctober 11, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Medical University of Vienna, Internal Medicine III, Clinical Div. of Nephrology and Dialysis
Enrollment: 48
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

October 11, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Medical University of Vienna, Internal Medicine III, Clinical Div. of Nephrology and Dialysis

•CKD patients with type 2 diabetes
•Estimated GFR (calculated with the MDRD formula) between 15 and 59 ml/min (with CKD stage IIIa/b to IV)
•Albumin excretion rates of \>30 mg/24 hours (UACR \>30 mg/g)
•Fasting plasma glucose levels \>126 mg/dl \[7mmol/L] or HbA1c levels \>6\.5% (Definition of type 2 diabetes according to the diagnostic criteria set forth by the American Diabetes Association in 2009\)
•CKD patients without diabetes
•Estimated GFR (calculated with the MDRD formula) between 15 and 59 ml/min (with CKD stage IIIa/b to IV)
•Albumin excretion rates of \>30 mg/24 hours (UACR \>30 mg/g)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•CKD patients with type 2 diabetes
•Age \<18 years
•Severely impaired renal function (eGFR \<15ml/min)
•Hyperkalemia above 5,1mmol/L
•Hypotension (systolic blood pressure lower than 120 mmHg on ambulatory measurement)
•Pregnant patients
•Patients planning pregnancy
•Body mass index \< 18\.5 kg/m2
•Total urinary protein excretion \= 3\.5 g/d
•CKD patients without diabetes