NCT02925221Completed
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)
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 530 (actual)
- First submitted
- 30 Sept 2016
- Start date
- 26 Feb 2016
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Otsuka Canada Pharmaceutical Inc.
- Diseases
- Polycystic kidney disease
- NCT number
- NCT02925221
What you commit to
- Study type: Observational
- Participants enrolled: 530
- From 26 Feb 2016 to the primary completion date, 31 Dec 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- The patient has any condition which, as per the judgment of the treating physician, prohibits them from participating in the study
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
Related publications
- Eight Years of Canadian Real-World Assessment of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease: The C-MAJOR Registry.Can J Kidney Health Dis · 2026 · PMID 41541406
This page is information, not medical advice. Discuss any trial with your doctor.