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NCT Number: NCT02925221

Canadian Medical Assessment of JINARC™ Outcomes Registry

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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Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD) Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Changes from baseline in Medical Outcomes Study Short-Form 12 (MOS-SF-12v2) score

    Time frame: Maximum of 120 months

  2. Changes from baseline in Autosomal Dominant Polycystic Kidney Disease-Impact Scale (ADPKD-IS) score

    Time frame: Maximum of 120 months

  3. Changes from baseline in ADPKD - Pain & Discomfort Scale (ADPKD-PDS) score

    Time frame: Maximum of 120 months

  4. Description of Health Care Resource Utilization

    Time frame: Maximum of 120 months

  5. Work and productivity loss measured with the Work Productivity and Activity Impairment (WPAI) questionnaire

    Time frame: Maximum of 120 months

Secondary outcomes

  1. Time to renal replacement therapy

    Time frame: Maximum of 120 months

  2. Long-term mortality rate and causes

    Time frame: Maximum 120 months

  3. Changes in markers of renal function

    Time frame: 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

  4. Adherence to treatment measured with the Medication Adherence Questionnaire

    Time frame: Maximum of 120 months

  5. Time to tolvaptan treatment discontinuation

    Time frame: Maximum of 120 months

  6. Long-term safety profile of tolvaptan

    Time frame: Maximum of 120 months

    Incidence of adverse events

Sponsors and collaborators

Lead sponsor

Otsuka Canada Pharmaceutical Inc.

Industry

Registry information

Official study title

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

Acronym: C-MAJOR

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2016
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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