Canadian Observational Cohort Study of the Real-life Assessment of Tolvaptan (JINARC™) in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 530
- 试验地点
- 6
- 主要终点
- Changes from baseline in Medical Outcomes Study Short-Form 12 (MOS-SF-12v2) score
研究概览
简要总结
This study is part of the Health Canada approval requirement for JINARC™ (tolvaptan) and is an observational, non-interventional study (NIS) describing the impact of tolvaptan on ADPKD-related burden of illness as measured with a set of Patient Reported Outcome (PRO) Questionnaires. The study is also describing the time to renal replacement therapy (RRT), such as dialysis and transplantation, and the long-term mortality rate and causes (i.e. renal and hepatic), in ADPKD patients treated with JINARC™ (tolvaptan)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ADPKD patients ≥18 years old at the time of tolvaptan initiation
- •The treating physician must have reached the decision to treat the patient with JINARC™ (tolvaptan) as per the Canadian Product Monograph prior to and independently of soliciting the patient to participate in the study
- •The patient or legal guardian must have signed an informed consent indicating the understanding of the study and allowing the use of their anonymous data for the purposes of the study
排除标准
- •The patient does not comprehend or refuses to sign the informed consent
- •The patient has any contraindications to the use of JINARC™ (tolvaptan) as specified in the Canadian Product Monograph
- •The patient has any condition which, as per the judgment of the treating physician, prohibits them from participating in the study
研究组 & 干预措施
ADPKD patients on tolvaptan
ADPKD patients who are newly prescribed with JINARC™ (tolvaptan) or already treated with JINARC™ (tolvaptan) will be eligible.
结局指标
主要结局
Changes from baseline in Medical Outcomes Study Short-Form 12 (MOS-SF-12v2) score
时间窗: Maximum of 120 months
Description of Health Care Resource Utilization
时间窗: Maximum of 120 months
Work and productivity loss measured with the Work Productivity and Activity Impairment (WPAI) questionnaire
时间窗: Maximum of 120 months
Changes from baseline in Autosomal Dominant Polycystic Kidney Disease-Impact Scale (ADPKD-IS) score
时间窗: Maximum of 120 months
Changes from baseline in ADPKD - Pain & Discomfort Scale (ADPKD-PDS) score
时间窗: Maximum of 120 months
次要结局
- Time to renal replacement therapy(Maximum of 120 months)
- Long-term mortality rate and causes(Maximum 120 months)
- Adherence to treatment measured with the Medication Adherence Questionnaire(Maximum of 120 months)
- Time to tolvaptan treatment discontinuation(Maximum of 120 months)
- Changes in markers of renal function(Maximum of 120 months)
- Long-term safety profile of tolvaptan(Maximum of 120 months)