Clinical trial NCT02925221: Canadian Medical Assessment of JINARC™ Outcomes Registry
Official title: Canadian Observational Cohort Study of the Real-life Assessment of Tolvaptan (JINARC™) in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Keywords: Kidney Disease
ADPKD-Related Outcome
Quality of Life
Lead sponsor: Otsuka Canada Pharmaceutical Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)


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

Primary outcomes:
measure: Changes from baseline in Medical Outcomes Study Short-Form 12 (MOS-SF-12v2) score
timeFrame: Maximum of 120 months
measure: Changes from baseline in Autosomal Dominant Polycystic Kidney Disease-Impact Scale (ADPKD-IS) score
timeFrame: Maximum of 120 months
measure: Changes from baseline in ADPKD - Pain & Discomfort Scale (ADPKD-PDS) score
timeFrame: Maximum of 120 months
measure: Description of Health Care Resource Utilization
timeFrame: Maximum of 120 months
measure: Work and productivity loss measured with the Work Productivity and Activity Impairment (WPAI) questionnaire
timeFrame: Maximum of 120 months
Secondary outcomes:
measure: Time to renal replacement therapy
timeFrame: Maximum of 120 months
measure: Long-term mortality rate and causes
timeFrame: Maximum 120 months
measure: Changes in markers of renal function
timeFrame: Maximum of 120 months
measure: Adherence to treatment measured with the Medication Adherence Questionnaire
timeFrame: Maximum of 120 months
measure: Time to tolvaptan treatment discontinuation
timeFrame: Maximum of 120 months
measure: Long-term safety profile of tolvaptan
timeFrame: Maximum of 120 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
state: Alberta
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
Study officials:
References: