Observational assessment of JINARC™ outcomes in ADPKD patients
Canadian Observational Cohort Study of the Real-life Assessment of Tolvaptan (JINARC™) in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Otsuka Canada Pharmaceutical Inc. · NCT02925221
This study looks at how well JINARC™ helps people with Autosomal Dominant Polycystic Kidney Disease feel and live longer while gathering important information for its approval in Canada.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 530 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Otsuka Canada Pharmaceutical Inc. (industry) |
| Locations | 6 sites (Edmonton, Alberta and 5 other locations) |
| Trial ID | NCT02925221 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the impact of JINARC™ (tolvaptan) on patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). It focuses on measuring the burden of illness through Patient Reported Outcome (PRO) questionnaires, as well as tracking the time to renal replacement therapy and long-term mortality rates. The study is part of the Health Canada approval process for JINARC™ and aims to gather real-world data on its effectiveness and safety in treating ADPKD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with ADPKD who are being treated with JINARC™.
Not a fit: Patients who have contraindications to JINARC™ or do not understand or refuse to sign the informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of JINARC™ in improving the quality of life and health outcomes for ADPKD patients.
How similar studies have performed: Other studies have shown success in evaluating the outcomes of treatments for ADPKD, making this approach relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edmonton, Alberta and 5 other locations
- Edmonton, Alberta, Canada (RECRUITING)
- London, Ontario, Canada (RECRUITING)
- Ottawa, Ontario, Canada (RECRUITING)
- Toronto, Ontario, Canada (RECRUITING)
- Montreal, Quebec, Canada (RECRUITING)
- Quebec City, Quebec, Canada (RECRUITING)
Study contacts
- Study coordinator: Annick Laplante
- Email: Annick.Laplante@otsuka-ca.com
- Phone: +1 514-654-8616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autosomal Dominant Polycystic Kidney Disease, Kidney Disease, ADPKD-Related Outcome, Quality of Life