Canadian Medical Assessment of JINARC™ Outcomes Registry

Study Overview
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Brief Summary
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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)

Official Title
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Canadian Observational Cohort Study of the Real-life Assessment of Tolvaptan (JINARC™) in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Conditions
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Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ADPKD patients on tolvaptan<br>ADPKD patients who are newly prescribed with JINARC™ (tolvaptan) or already treated with JINARC™ (tolvaptan) will be eligible. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Medical Outcomes Study Short-Form 12 (MOS-SF-12v2) score |  | Maximum of 48 months | 
| Changes from baseline in Autosomal Dominant Polycystic Kidney Disease-Impact Scale (ADPKD-IS) score |  | Maximum of 48 months | 
| Changes from baseline in ADPKD - Pain & Discomfort Scale (ADPKD-PDS) score |  | Maximum of 48 months | 
| Description of Health Care Resource Utilization |  | Maximum of 48 months | 
| Work and productivity loss measured with the Work Productivity and Activity Impairment (WPAI) questionnaire |  | Maximum of 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to renal replacement therapy |  | Maximum of 48 months | 
| Long-term mortality rate and causes |  | Maximum 48 months | 
| Changes in markers of renal function | Markers of renal function: Total Kidney Volume (mL); Kidney Length (cm); estimated Glomerular Filtration Rate (eGFR); Chronic Kidney Disease (CKD) stage | Maximum of 48 months | 
| Adherence to treatment measured with the Medication Adherence Questionnaire |  | Maximum of 48 months | 
| Time to tolvaptan treatment discontinuation |  | Maximum of 48 months | 
| Long-term safety profile of tolvaptan | Incidence of adverse events | Maximum of 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Disease, ADPKD-Related Outcome, Quality of Life