A Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 主要终点
- Total Kidney Volume
研究概览
简要总结
ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 53 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has been completed.
- •Patients who completed 3-year repeated administration and who completed the second follow-up visit or patients whose treatment with the trial drug was interupted due to pregnancy and who completed out the second follow-up visit in Trial 156-04-
- •Patients in whom any adverse events occurring in Trial 156-04-251 were resolved orstabilized and require no further follow-up.
排除标准
- •Patients with eGFR of less than 15 mL/min/1.73 m2
- •Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant
- •Patients who received any investigational drug other than Tolvaptan within 30 days prior to commencement of administration of tolvaptan
- •Any patients who, in the opinion of the principle investigator or subinvestigators, should not participate in the study
研究组 & 干预措施
tolvaptan
Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
干预措施: tolvaptan (Drug)
结局指标
主要结局
Total Kidney Volume
时间窗: Baseline, Month12, Month24, and Month36
Measured values of total kidney volume (sum of the volume of the left and right kidneys) during trial period. Twice-daily repeated oral administration of tolvaptan at daily doses of 60 to 120 mg. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded.
Renal Function Test (eGFR)
时间窗: Baseline, Month12, Month24, and Month36
Estimated glomerular filtration rate calculated by Japanese equation for eGFR during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded.
Renal Function Test (Cys-C)
时间窗: Baseline, Month 12, Month 24, and Month 36
Measured values of serum cystatin C concentration during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded.
次要结局
未报告次要终点