Canadian Medical Assessment of JINARC Outcomes Registry

  • STATUS
    Recruiting
  • End date
    Mar 27, 2022
  • participants needed
    500
  • sponsor
    Otsuka Canada Pharmaceutical Inc.
Updated on 27 January 2021

Summary

This study is part of the Health Canada approval requirement for 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 tolvatan (JINARC)

Details
Condition Polycystic Kidney, Autosomal Dominant, autosomal dominant polycystic kidney disease
Clinical Study IdentifierNCT02925221
SponsorOtsuka Canada Pharmaceutical Inc.
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Polycystic Kidney, Autosomal Dominant?
Do you have any of these conditions: autosomal dominant polycystic kidney disease or Polycystic Kidney, Autosomal Dominant?
ADPKD patients 18 years old at the time of tolvaptan initiation
The treating physician must have reached the decision to treat the patient with 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 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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