Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Conditions
Brief summary
To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.
Interventions
None listed
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* existing diagnosis of ADPKD by modified-Ravine criteria * Total kidney volume \>= 300 cc/m height by ultrasound or \>= 250 cc/m height by MRI
Exclusion criteria
* Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation of change in total kidney volume with ADPKD-related outcomes | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported pain | every 6 months |
| SF-12 Scores | every 6 months |
| ADPKD-Impact Scale Score | every 6 months |
| Cost of care | every 6 months |
| EQ-5D Scores | Every 6 months |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Italy, Japan, Netherlands, Norway, Poland, Romania, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed