Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,802
- 试验地点
- 1
- 主要终点
- Estimated Slope of Total Kidney Volume During Pre-administration and Administration
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) in the real world clinical setting in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed ADPKD
- •total kidney volume of 750 or more
排除标准
- 未提供
研究组 & 干预措施
ADPKD
干预措施: tolvaptan (Drug)
结局指标
主要结局
Estimated Slope of Total Kidney Volume During Pre-administration and Administration
时间窗: Pre-administration: From the first pre-treatment measurement (up to 12.5 years prior) to the start of tolvaptan. During-treatment: From the start of tolvaptan to the final follow-up (up to 8.0 years later).
Total Kidney Volume (TKV) was used as a biomarker to assess the progression of ADPKD. TKV was measured at each participating site based on imaging obtained via ultrasound, CT, or MRI. The Estimated Slope pre-administration was calculated for subjects who had TKV measurements both prior to and on the day of Tolvaptan initiation (baseline). The rate of change in TKV from the pre-treatment measurement date to the baseline was used to determine the Estimated Slope. Since the date of initiating tolvaptan administration is considered the start date of the study, the kidney volume measured prior to administration falls outside the study period (i.e., it is a value from before the study start date). The Estimated Slope during-treatment was calculated for subjects who had bilateral TKV measurements at baseline and during the treatment period. The rate of change in TKV from baseline to the measurement date during treatment was used to determine the Estimated Slope.
次要结局
- The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)(From the date of Tolvaptan initiation to the earlier of either the date when ALT reached three times the upper limit of normal or the date of Tolvaptan discontinuation (up to 2789 days).)
- The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)(From the date of Tolvaptan initiation to the earlier of either the date when AST reached three times the upper limit of normal or the date of Tolvaptan discontinuation (up to 2789 days).)