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临床试验/EUCTR2020-001595-15-DK
EUCTR2020-001595-15-DK进行中(未招募)1 期

The Measures to Optimize RAAS-blockade in Patients with Hyperkalemia and Chronic Kidney Disease - MorphCKD

Henrik Birn0 个研究点目标入组 140 人开始时间: 2020年4月24日最近更新:
适应症
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
140

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 18-80 years
  • 2.eGFR 25-60 mL/min/1.73 m2
  • 3.Latest P-potassium > 4.5 mmol/L or b) P-kalium > 4.5 mmol/L at least twice within the last 24 months
  • 4.Urine albumin creatinine ratio > 500 mg/g or 200mg/g and diabetes
  • 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 70
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 70

排除标准

  • 1.Intolerance or allergic to Losartan, Spironolactone or Patiromer
  • 2.Previous renal transplant recipient or active on the waiting ling
  • 3.End stage renal disease (defined as the need for dialysis or renal transplantation)
  • 4.Any condition that currently or through the duration of the study would require specific immunosuppressive therapy
  • 5.Pregnancy
  • 6.Regular use of Trimethoprim and/or NSAIDs
  • 7.Disseminated cancer disease
  • 8.Addisons disease
  • 9.History of heart failure defined as Ejection Fraction (EF) < 40% or currently receiving treatment at a heart failure clinic or similar
  • 10.Porphyria
  • 11.Severe constipation requiring daily and chronic use of laxatives and/or previous recurrent ileus (> 1 incident in the past 10 years without curative treatment
  • 12.Fructose intolerance
  • 13.Galactose intolerance
  • 14.A history of severe liver insufficiency (Child–Pugh score B-C)
  • 15. SGLT2-inhibitor treatment initated = 30 days prior to inclusion

研究者

发起方
Henrik Birn

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