Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease
- Conditions
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- Registration Number
- NCT01430494
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3409
- existing diagnosis of ADPKD by modified-Ravine criteria
- Total kidney volume >= 300 cc/m height by ultrasound or >= 250 cc/m height by MRI
- Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation of change in total kidney volume with ADPKD-related outcomes 1 year
- Secondary Outcome Measures
Name Time Method SF-12 Scores every 6 months EQ-5D Scores Every 6 months ADPKD-Impact Scale Score every 6 months Cost of care every 6 months Patient-reported pain every 6 months
Trial Locations
- Locations (5)
Otsuka Investigational Site 2
🇺🇸Peoria, Arizona, United States
Otuska Investigational Site
🇫🇷Lyon cedex 3, France
Otsuka Investigational Site
🇬🇧Wolverhampton, United Kingdom
Otsuka Investigational Sites
🇦🇷Pergamino, Buenos Aires, Argentina
Otsuka Investigational Site 1
🇺🇸Peoria, Arizona, United States