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临床试验/EUCTR2020-000433-40-NL
EUCTR2020-000433-40-NL进行中(未招募)1 期

Treatment of vascular stiffness in patients with autosomal dominant polycystic kidney disease - TRAMPOLINE

Erasmus University Medical Centre Rotterdam0 个研究点目标入组 54 人开始时间: 2021年8月3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
54

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

  • Inclusion Criteria:
  • Adults with ADPKD diagnosis based on Ravine criteria and/or with PKD1 or PKD2 mutation
  • CKD-EPI eGFR = 60 ml/min/1.73m2
  • Ability to provide informed consent
  • 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 44
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • - Uncontrolled hypertension, defined as an office blood pressure of =160/ =90 mmHg with or without antihypertensive treatment
  • - Concomitant use of =3 antihypertensive medications
  • - Serum potassium levels >5.5 mmol/L (measured within last 6 months)
  • - History of liver disease (excluding liver cysts due to ADPKD)
  • - History of heart failure (cardiac ejection fraction < 35%) or cardiac arrhythmia
  • - History of diabetes mellitus
  • - Active infection or antibiotic therapy
  • - Immunosuppressive therapy within the last year
  • - Concomitant use of drugs that could influence blood pressure and/or disease progression (Tolvaptan/non-steroidal anti-inflammatory drugs (NSAIDs)/chemotherapy), excluding <3 antihypertensive drugs
  • - Actual pregnancy or unwillingness to adhere to reproductive precautions during the duration of the study

研究者

发起方
Erasmus University Medical Centre Rotterdam

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