Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Conditions
Keywords
Kidney Disease, ADPKD-Related Outcome, Quality of Life
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)
Interventions
None listed
Sponsors
Otsuka Canada Pharmaceutical Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in Medical Outcomes Study Short-Form 12 (MOS-SF-12v2) score | Maximum of 120 months |
| Changes from baseline in Autosomal Dominant Polycystic Kidney Disease-Impact Scale (ADPKD-IS) score | Maximum of 120 months |
| Changes from baseline in ADPKD - Pain & Discomfort Scale (ADPKD-PDS) score | Maximum of 120 months |
| Description of Health Care Resource Utilization | Maximum of 120 months |
| Work and productivity loss measured with the Work Productivity and Activity Impairment (WPAI) questionnaire | Maximum of 120 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to renal replacement therapy | Maximum of 120 months | — |
| Long-term safety profile of tolvaptan | Maximum of 120 months | Incidence of adverse events |
| Long-term mortality rate and causes | Maximum 120 months | — |
| Changes in markers of renal function | 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 |
| Adherence to treatment measured with the Medication Adherence Questionnaire | Maximum of 120 months | — |
| Time to tolvaptan treatment discontinuation | Maximum of 120 months | — |
Countries
Canada
Outcome results
None listed