Canadian Medical Assessment of JINARC™ Outcomes Registry

Last updated: July 28, 2025
Sponsor: Otsuka Canada Pharmaceutical Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02925221
156-203-00047
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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 withJINARC™ (tolvaptan) as per the Canadian Product Monograph prior to and independentlyof soliciting the patient to participate in the study

  • The patient or legal guardian must have signed an informed consent indicating theunderstanding of the study and allowing the use of their anonymous data for thepurposes of the study

Exclusion

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 specifiedin 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 Design

Total Participants: 530
Study Start date:
February 26, 2016
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • empty

    Calgary, Alberta
    Canada

    Site Not Available

  • Edmonton, Alberta
    Canada

    Active - Recruiting

  • empty

    Moncton, New Brunswick
    Canada

    Site Not Available

  • empty

    Saint John, New Brunswick
    Canada

    Site Not Available

  • empty

    Halifax, Nova Scotia
    Canada

    Site Not Available

  • empty

    Sydney, Nova Scotia
    Canada

    Site Not Available

  • empty

    Brampton, Ontario
    Canada

    Site Not Available

  • London, Ontario
    Canada

    Active - Recruiting

  • empty

    Mississauga, Ontario
    Canada

    Site Not Available

  • empty

    Oakville, Ontario
    Canada

    Site Not Available

  • Ottawa, Ontario
    Canada

    Active - Recruiting

  • empty

    Richmond Hill, Ontario
    Canada

    Site Not Available

  • empty

    Scarborough, Ontario
    Canada

    Site Not Available

  • Toronto, Ontario
    Canada

    Active - Recruiting

  • empty

    Greenfield Park, Quebec
    Canada

    Site Not Available

  • Montreal, Quebec
    Canada

    Active - Recruiting

  • Quebec City, Quebec
    Canada

    Active - Recruiting

  • empty

    Rimouski, Quebec
    Canada

    Site Not Available

  • empty

    Saskatoon, Saskatchewan
    Canada

    Site Not Available

  • empty

    Quebec,
    Canada

    Site Not Available

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