C-MAJOR: Canadian Medical Assessment of JINARC™ Outcomes Registry
Study Details
Study Description
Brief 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™)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ADPKD patients on tolvaptan ADPKD patients who are newly prescribed with tolvaptan or already treated with tolvaptan will be eligible. |
Outcome Measures
Primary Outcome Measures
- 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
- Time to renal replacement therapy [Maximum of 48 months]
- Long-term mortality rate and causes [Maximum 48 months]
- Changes in markers of renal function [Maximum of 48 months]
Markers of renal function: Total Kidney Volume (mL); Kidney Length (cm); estimated Glomerular Filtration Rate (eGFR); Chronic Kidney Disease (CKD) stage
- 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 [Maximum of 48 months]
Incidence of adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
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ADPKD patients ≥18 years old at the time of tolvaptan initiation
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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
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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:
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The patient does not comprehend or refuses to sign the informed consent
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The patient has any contraindications to the use of tolvaptan as specified in the Canadian Product Monograph
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The patient has any condition which, as per the judgment of the treating physician, prohibits them from participating in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Edmonton | Alberta | Canada | ||
| 2 | Moncton | New Brunswick | Canada | ||
| 3 | Saint John | New Brunswick | Canada | ||
| 4 | Halifax | Nova Scotia | Canada | ||
| 5 | Sydney | Nova Scotia | Canada | ||
| 6 | Brampton | Ontario | Canada | ||
| 7 | London | Ontario | Canada | ||
| 8 | Mississauga | Ontario | Canada | ||
| 9 | Ottawa | Ontario | Canada | ||
| 10 | Richmond Hill | Ontario | Canada | ||
| 11 | Toronto | Ontario | Canada | ||
| 12 | Greenfield Park | Quebec | Canada | ||
| 13 | Montreal | Quebec | Canada | ||
| 14 | Quebec City | Quebec | Canada | ||
| 15 | Rimouski | Quebec | Canada |
Sponsors and Collaborators
- Otsuka Canada Pharmaceutical Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 156-203-00047