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
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