Clinical Trials Directory

Trials / Completed

CompletedNCT02925221

Canadian Medical Assessment of JINARC™ Outcomes Registry

Canadian Observational Cohort Study of the Real-life Assessment of Tolvaptan (JINARC™) in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Status
Completed
Phase
Study type
Observational
Enrollment
530 (actual)
Sponsor
Otsuka Canada Pharmaceutical Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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)

Conditions

Timeline

Start date
2016-02-26
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2016-10-05
Last updated
2026-01-07

Locations

6 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT02925221. Inclusion in this directory is not an endorsement.