Canadian Medical Assessment of JINARC™ Outcomes Registry

NCT02925221 | Completed DMC

• 1 other identifier: 156-203-00047
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 6

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)

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Keywords

Kidney Disease; ADPKD-Related Outcome; Quality of Life

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (6)

• Time to renal replacement therapy

  Maximum of 120 months

• Long-term mortality rate and causes

  Maximum 120 months

• Changes in markers of renal function

  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

Study Arms (1)

ADPKD patients on tolvaptan

ADPKD patients who are newly prescribed with JINARC™ (tolvaptan) or already treated with JINARC™ (tolvaptan) will be eligible.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Canada Pharmaceutical Inc.: lead

Study Sites (6)

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Ottawa, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Québec, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 41541406 DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Kidney Diseases

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 5, 2016
• Study Start: February 26, 2016
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 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.

Locations

CA (6)