EUCTR2017-004115-39-DK进行中（未招募）1 期
Subacute Effect of Tolvaptan on Total Kidney Volumen in Adult Patients with Autosomal Dominant Polycystic Kidney Disease
ordsjællands Hospital, Department of Cardiology, Nephrology and Endocrinology0 个研究点目标入组 90 人开始时间: 2017年12月13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
- 90
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
- •Adult patients aged between 18 and 65 years
- •Diagnosis of typical ADPKD
- •tKV above or equal to 750 ml by MRI scanning
- •Estimated GFR (e-GFR) by CKD-SPI formula of above or equal to 45mL/min/1.73m2
- •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 90
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Kidney transplant recipient
- •Known liver disease except for liver cysts relating to ADPKD
- •ASAT and ALAT above upper normal level
- •Current treatment with thiazide and thiazide-like diuretics, mineralcortocoid receptor antagonists, amiloride or loop diuretics
- •Evidence of urinary tract obstruction
- •Current treatment with CYP3A4 inhibitors
- •Active malignant disease
- •Current or previous treatment with tolvaptan
研究者
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