Canadian Medical Assessment of JINARC™ Outcomes Registry

Autosomal Dominant Polycystic Kidney Disease (ADPKD) Clinical Trial

— C-MAJOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02925221
• Other study ID #: 156-203-00047
• Status: Recruiting
• Start date: January 2016
• Est. completion date: June 2026

Study information

• Verified date: February 2024
• Source: Otsuka Canada Pharmaceutical Inc.
• Contact: Annick Laplante
• Phone: +1 514-654-8616
• Email: Annick.Laplante[@]otsuka-ca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 530
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Canada Pharmaceutical Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in Medical Outcomes Study Short-Form 12 (MOS-SF-12v2) score		Maximum of 120 months
Primary	Changes from baseline in Autosomal Dominant Polycystic Kidney Disease-Impact Scale (ADPKD-IS) score		Maximum of 120 months
Primary	Changes from baseline in ADPKD - Pain & Discomfort Scale (ADPKD-PDS) score		Maximum of 120 months
Primary	Description of Health Care Resource Utilization		Maximum of 120 months
Primary	Work and productivity loss measured with the Work Productivity and Activity Impairment (WPAI) questionnaire		Maximum of 120 months
Secondary	Time to renal replacement therapy		Maximum of 120 months
Secondary	Long-term mortality rate and causes		Maximum 120 months
Secondary	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 120 months
Secondary	Adherence to treatment measured with the Medication Adherence Questionnaire		Maximum of 120 months
Secondary	Time to tolvaptan treatment discontinuation		Maximum of 120 months
Secondary	Long-term safety profile of tolvaptan	Incidence of adverse events	Maximum of 120 months