Canadian Medical Assessment of JINARC™ Outcomes Registry

Launched by OTSUKA CANADA PHARMACEUTICAL INC. · Oct 4, 2016

Keywords

ClinConnect Summary

The Canadian Medical Assessment of JINARC™ Outcomes Registry is a study that looks at how the medication JINARC™ (tolvaptan) affects patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). This study is not testing a new treatment but is observing how well JINARC™ works in real-life situations. Researchers want to understand how the medication impacts patients’ quality of life, how long it takes for patients to need treatments like dialysis or kidney transplants, and the long-term health outcomes of those taking JINARC™.

To participate in this study, you must be at least 18 years old and have been prescribed JINARC™ by your doctor. You will also need to give your consent to join the study, meaning you agree to have your information used anonymously to help researchers learn more. While the study is open to all eligible patients, it is important to note that individuals who cannot sign the consent form or have specific health issues that prevent them from taking JINARC™ may not be able to participate. If you join, you can expect to complete some questionnaires about your health and experiences while being treated with JINARC™, contributing valuable information to help improve care for future patients with ADPKD.

Gender

ALL

Eligibility 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