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.
Brief Title
Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease
Categories
Completion Date
Completion Date Type
Actual
Conditions
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* existing diagnosis of ADPKD by modified-Ravine criteria
* Total kidney volume \>= 300 cc/m height by ultrasound or \>= 250 cc/m height by MRI
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
12 Years
NCT Id
NCT01430494
Org Class
Industry
Org Full Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
Org Study Id
156-10-291
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Measure
Correlation of change in total kidney volume with ADPKD-related outcomes
Outcome Time Frame
1 year
Secondary Outcomes
Outcome Time Frame
every 6 months
Outcome Measure
Patient-reported pain
Outcome Time Frame
every 6 months
Outcome Measure
SF-12 Scores
Outcome Time Frame
every 6 months
Outcome Measure
ADPKD-Impact Scale Score
Outcome Time Frame
every 6 months
Outcome Measure
Cost of care
Outcome Time Frame
Every 6 months
Outcome Measure
EQ-5D Scores
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Subjects will be identified by participating clinics (primarily nephrology clinics) treating patients with ADPKD.
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Beatrice Goilav
Investigator Email
bgoilav@montefiore.org
Investigator Phone