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临床试验/EUCTR2016-002935-14-AT
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:
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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

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

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