EUCTR2016-002935-14-AT进行中(未招募)1 期
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 个研究点目标入组 48 人开始时间: 2016年10月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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
研究者
相似试验
已完成
不适用
Influence of eplerenone on renin-angiotensin-aldosterone system and left ventricular remodeling after cardiac surgeryJPRN-UMIN000001468ihon University School of Medicine300
已完成
1 期
Can losartan reduce fibrosis and slow the decline of kidney function in kidney transplant patients?Allograft nephritisUrological and Genital DiseasesISRCTN15884223Shahid Beheshti Medical University50
已完成
2 期
EMPRA (EMPagliflozin and RAs in Kidney Disease)Diabetic Kidney DiseaseChronic Kidney Disease stage3Chronic Kidney Disease stage4Diabetes Mellitus, Type 2NCT03078101Medical University of Vienna51
Unknown
不适用
Antidiuretic Function Before and During Treatment With SGLT2 InhibitorsArterial HypertensionBody Weight ChangesDiabetes Mellitus, Type 2NCT03917758University of Turin, Italy30
已完成
不适用
Influence of angiotensin receptor blocker on renin-angiotensin-aldosterone system after cardiac surgeryJPRN-UMIN000001463Sekino Hospital200
