Canadian Medical Assessment of JINARC™ Outcomes Registry
Autosomal Dominant Polycystic Kidney Disease (ADPKD)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)
null
Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Study Location
Toronto, Ontario
Canada
Contact Study Team
Ottawa, Ontario
Canada
Contact Study Team
Edmonton, Alberta
Canada
Contact Study Team
Montreal, Quebec
Canada
Contact Study Team
London, Ontario
Canada
Contact Study Team
Quebec City, Quebec
Canada
Contact Study Team
- Study Sponsored By
- Otsuka Canada Pharmaceutical Inc.
- Participants Required
- More Information
- Study ID:
NCT02925221