Canadian Medical Assessment of JINARC™ Outcomes Registry (C-MAJOR)

Otsuka

Status: Completed

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study type: Observational

Funder types: Industry

Identifiers

NCT02925221

156-203-00047

Details and patient eligibility

About

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)

Enrollment: 530 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

530 participants in 1 patient group

ADPKD patients on tolvaptan

Description:

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