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临床试验/EUCTR2005-002407-17-DE
EUCTR2005-002407-17-DE进行中(未招募)不适用

Effects of rosiglitazone on renal hemodynamics and proteinuria of type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy

Technical University Dresden0 个研究点目标入组 38 人开始时间: 2005年12月19日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
38

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

性别
All

入选标准

  • -type 2 diabetes mellitus
  • -age between 40 and 70 years
  • -well controlled HbA1c (< 7.5%)
  • -chronic renal failure (creatinin clearance between 70 and 30 mL/(min x 1.73 m²) according to the Cockroft equation)
  • -proteinuria > 300 mg / 24 hours
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -type 1 diabetes
  • -poorly controlled type 2 diabetes (HbA1c > 7.5%) or unstable blood glucose during the day (capillary blood glucose self monitoring)
  • -elevation of ALT, AST or GGT more than 2.5 fold the upper normal value
  • -CHF (more than grade 1 of NYHA)
  • -uncontrolled hypertension
  • -malignant tumorous disorder
  • -hyper- or hypothyroidism
  • -pregnant women
  • -nursing women

研究者

发起方
Technical University Dresden

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