Canadian Medical Assessment of JINARC™ Outcomes Registry

Recruiting

• Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

• Registration Number: NCT02925221
• Lead Sponsor: Otsuka Canada Pharmaceutical Inc.

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-09-30
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 530

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of Health Care Resource Utilization	Maximum of 120 months
Changes from baseline in Medical Outcomes Study Short-Form 12 (MOS-SF-12v2) score	Maximum of 120 months
Work and productivity loss measured with the Work Productivity and Activity Impairment (WPAI) questionnaire	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

Secondary Outcome Measures

Name	Time	Method
Time to renal replacement therapy	Maximum of 120 months
Long-term mortality rate and causes	Maximum 120 months
Adherence to treatment measured with the Medication Adherence Questionnaire	Maximum of 120 months
Time to tolvaptan treatment discontinuation	Maximum of 120 months
Changes in markers of renal function	Maximum of 120 months	Markers of renal function: Total Kidney Volume (mL); Kidney Length (cm); estimated Glomerular Filtration Rate (eGFR); Chronic Kidney Disease (CKD) stage
Long-term safety profile of tolvaptan	Maximum of 120 months	Incidence of adverse events