Characterization of Renin-Angiotensin-System at patients with Empagliflozin therapy and Angiotensin-converting enzyme inhibition.

Phase 1

• Conditions: Chronic kidney disease with and without type 2 diabetes; MedDRA version: 20.0 Level: LLT Classification code 10076411 Term: Chronic kidney disease stage 4 System Organ Class: 100000004857; MedDRA version: 20.0 Level: LLT Classification code 10076410 Term: Chronic kidney disease stage 3 System Organ Class: 100000004857; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-002935-14-AT
• Lead Sponsor: Medical University of Vienna, Internal Medicine III, Clinical Div. of Nephrology and Dialysis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-11
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

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
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

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
•Age <18 years
•Diabetic kidney disease
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified