EUCTR2016-002935-14-ATActive, not recruitingPhase 1
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 enrollmentStarted: October 11, 2016Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 48
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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
Investigators
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