NCT01430494CompletedNot Applicable
A Multi-center, Longitudinal, Observational Study of Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) to Establish the Rate, Characteristics, and Determinants of Disease Progression
Otsuka Pharmaceutical Development & Commercialization, Inc.271 sites in 4 countries3,409 target enrollmentStarted: June 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 3,409
- Locations
- 271
- Primary Endpoint
- Correlation of change in total kidney volume with ADPKD-related outcomes
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 12 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
No treatment
Outcomes
Primary Outcomes
Correlation of change in total kidney volume with ADPKD-related outcomes
Time Frame: 1 year
Secondary Outcomes
- SF-12 Scores(every 6 months)
- EQ-5D Scores(Every 6 months)
- ADPKD-Impact Scale Score(every 6 months)
- Patient-reported pain(every 6 months)
- Cost of care(every 6 months)
Investigators
Study Sites (271)
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