Canadian Medical Assessment of JINARC™ Outcomes Registry

Otsuka Canada Pharmaceutical Inc.530 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

530

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Unnamed facility

Edmonton, Alberta, Canada

Unnamed facility

London, Ontario, Canada

Unnamed facility

Ottawa, Ontario, Canada

Unnamed facility

Toronto, Ontario, Canada

Unnamed facility

Montreal, Quebec, Canada