Completed

This study has been completed.

Canadian Medical Assessment of JINARC™ Outcomes Registry (C-MAJOR)

NCT02925221Sponsor: Otsuka Canada Pharmaceutical Inc.Matthew WeirMatthew Weir

About This Study

This observational, non-interventional cohort study evaluates the real-world impact of tolvaptan in Canadian patients with ADPKD. The study assesses the burden of illness through patient-reported outcome questionnaires and tracks clinical progression to RRT, including dialysis and transplantation. Researchers monitor long-term mortality rates and specific causes of death, with a focus on renal and hepatic outcomes. The target population consists of ADPKD patients prescribed tolvaptan as part of routine clinical care following Health Canada approval.

Who Can Participate?

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