Efficacy Study of Long-term Water Intake on the Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Total kidney volume (TKV) measured by magnetic resonance imaging (MRI).
研究概览
简要总结
This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD.
详细描述
Tolvaptan was approved in Japan for the treatment of autosomal dominant polycystic kidney disease (ADPKD) in March 2014. This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD. Study results will be summarized, analyzed, and compiled into a research paper at 3 years (data cut-off, March 31, 2018) and at 5 years (data cut-off, March 31, 2020)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients with ADPKD
- •The patients who consent to the study protocol
- •Estimated glomerular filtration rate (eGFR) or Creatinine Clearance greater than 50ml/min/1.73m2
排除标准
- •Patients who might be danger to drink large amount of water such as having heart failure or past history of cerebrovascular or cardiovascular disorders.
- •The patients who take habitual medication which affects the AVP action such as selective serotonin reuptake inhibitors (SSRI ), tricyclic antidepressants or diuretics.
- •The patients who is considered inappropriate by physicians.
结局指标
主要结局
Total kidney volume (TKV) measured by magnetic resonance imaging (MRI).
时间窗: One year (12 months) and pre-study period.
The relationship between urine volume (and urine osmolality) and change of TKV. TKV slopes are compared between pre-study and study period.
次要结局
- Glomerular filtration rate (GFR) estimated by plasma creatinine and cystatin C.(One year (12 months))
- Plasma arginine vasopressin (AVP, Copeptin) level.(4-8-12 months)
- Quality of life (QOL) questionnaire.(4-8-12 months)
研究者
Eiji Higashihara, MD
Professor
Kyorin University