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临床试验/EUCTR2011-002243-98-DK
EUCTR2011-002243-98-DK进行中(未招募)1 期

The effect of spironolactone on calcineurin inhibitor induced nephrotoxicity - SPIRE

Department of Nephrology, OUH, Odense, DK0 个研究点目标入组 170 人开始时间: 2011年8月31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
170

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

  • 1. Age > 18 years
  • 2. Treated with a calcineurin inhibitor
  • 3. Proteinuria < 3 g/day
  • 4. Creatinine clearance = 30 mL/min
  • 5. Plasma potassium < 5.5 mmol/L
  • 6. Negative pregnancy test at inclusion for women of childbearing potential and adequate contraception throughout the trial
  • 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 150
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • 1. Former intolerance of spironolactone
  • 2. Already treated with spironolactone
  • 3. Resonium or Digoxin treatment
  • 4. Pregnancy or planned pregnancy
  • 5. Clinically relevant organic, systemic or psychological disorder
  • 6. Expectation of non-compliance

研究者

发起方
Department of Nephrology, OUH, Odense, DK

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