Canadian Medical Assessment of JINARC™ Outcomes Registry

Last updated: January 5, 2026
Sponsor: Otsuka Canada Pharmaceutical Inc.
Overall Status: Completed

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

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    Calgary, Alberta
    Canada

    Site Not Available

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    Edmonton, Alberta
    Canada

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  • Edmonton 5946768, Alberta 5883102
    Canada

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    Moncton, New Brunswick
    Canada

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    Saint John, New Brunswick
    Canada

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    Halifax, Nova Scotia
    Canada

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    Sydney, Nova Scotia
    Canada

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    Brampton, Ontario
    Canada

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    London, Ontario
    Canada

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    Mississauga, Ontario
    Canada

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    Oakville, Ontario
    Canada

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    Ottawa, Ontario
    Canada

    Site Not Available

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    Richmond Hill, Ontario
    Canada

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    Scarborough, Ontario
    Canada

    Site Not Available

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    Toronto, Ontario
    Canada

    Site Not Available

  • London 6058560, Ontario 6093943
    Canada

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  • Ottawa 6094817, Ontario 6093943
    Canada

    Site Not Available

  • Toronto 6167865, Ontario 6093943
    Canada

    Site Not Available

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    Greenfield Park, Quebec
    Canada

    Site Not Available

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    Montreal, Quebec
    Canada

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    Quebec City, Quebec
    Canada

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    Rimouski, Quebec
    Canada

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  • Montreal 6077243, Quebec 6115047
    Canada

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  • Québec 6325494, Quebec 6115047
    Canada

    Site Not Available

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    Saskatoon, Saskatchewan
    Canada

    Site Not Available

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    Quebec,
    Canada

    Site Not Available

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