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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADPKD patients on tolvaptan | ADPKD patients who are newly prescribed with JINARC™ (tolvaptan) or already treated with JINARC™ (tolvaptan) will be eligible. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Medical Outcomes Study Short-Form 12 (MOS-SF-12v2) score | Maximum of 120 months | |
| Changes from baseline in Autosomal Dominant Polycystic Kidney Disease-Impact Scale (ADPKD-IS) score | Maximum of 120 months | |
| Changes from baseline in ADPKD - Pain & Discomfort Scale (ADPKD-PDS) score | Maximum of 120 months | |
| Description of Health Care Resource Utilization | Maximum of 120 months | |
| Work and productivity loss measured with the Work Productivity and Activity Impairment (WPAI) questionnaire | Maximum of 120 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to renal replacement therapy | Maximum of 120 months | |
| Long-term mortality rate and causes | Maximum 120 months | |
| Changes in markers of renal function |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be adult patients newly prescribed with JINARC™ (tolvaptan) for the treatment of ADPKD, or patients who are on-treatment with JINARC™ (tolvaptan) at the time of enrolment. Investigator must be ADPKD experts qualified by experience and ability to perform the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edmonton | Alberta | Canada | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41541406 | Derived | McFarlane P, Bichet DG, Alam A, Bubolic S, Laplante A. Eight Years of Canadian Real-World Assessment of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease: The C-MAJOR Registry. Can J Kidney Health Dis. 2026 Jan 13;13:20543581251404128. doi: 10.1177/20543581251404128. eCollection 2026. |
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Participants consenting to share their data are consented and identified as such in the clinical database.
During the course of 2024, a CSR covering the study period from 2016 to the end of 2023 will be produced. Another CSR will be produced in 2026, after the conclusion of the 120-month study period.
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| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Markers of renal function: Total Kidney Volume (mL); Kidney Length (cm); estimated Glomerular Filtration Rate (eGFR); Chronic Kidney Disease (CKD) stage |
| Maximum of 120 months |
| Adherence to treatment measured with the Medication Adherence Questionnaire | Maximum of 120 months |
| Time to tolvaptan treatment discontinuation | Maximum of 120 months |
| Long-term safety profile of tolvaptan | Incidence of adverse events | Maximum of 120 months |
| London |
| Ontario |
| Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Québec | Quebec | Canada |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |