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Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

Not Applicable
Conditions
Autosomal dominant polycystic kidney disease (ADPKD)
Registration Number
JPRN-jRCT1080221699
Lead Sponsor
Otsuka Pharmaceutical Dvelopment & Commercialization, Inc.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Sex
All
Target Recruitment
3000
Inclusion Criteria

1) Existing diagnosis of ADPKD by modified-Ravine criteria
2) Total kidney volume >= 300 cc/m height by ultrasound or >= 250 cc/m height by MRI

Exclusion Criteria

1) 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
NameTimeMethod
Correlation of change in total kidney volume with ADPKD-related outcomes<br>every 1 year
Secondary Outcome Measures
NameTimeMethod
Patient-reported pain<br>every 6 months<br>SF-12 Scores<br>every 6 months<br>ADPKD-Impact Scale Scores<br>every 6 months<br>Cost of care<br>every 6 months<br>EuroQuol-5D Scores<br>every 6 months
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