Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

Completed

Conditions studied: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

In brief

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.

Key facts

Study ID

NCT01430494

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

3409

Starts

2011-06-01

Expected to finish

2014-10-01

Last updated by the study team

2026-04-28

Who can join

Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• existing diagnosis of ADPKD by modified-Ravine criteria
• Total kidney volume >= 300 cc/m height by ultrasound or >= 250 cc/m height by MRI

You may not qualify if…

• Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume

Where it is running

• Otsuka Investigational Site 2 — Peoria, Arizona, United States
• Otsuka Investigational Site — Tempe, Arizona, United States
• Otsuka Investigational Site — Azusa, California, United States
• Otsuka Investigational Site — Bakersfield, California, United States
• Otsuka Investigational Site — Los Angeles, California, United States
• Otsuka Investigational Site — Los Angeles, California, United States
• Otsuka Investigational Site — Ontario, California, United States
• Otsuka Investigational Site — San Diego, California, United States
• Otsuka Investigational Site — Arvada, Colorado, United States
• Otsuka Investigational Site — Aurora, Colorado, United States
• Otsuka Investigational Site — Denver, Colorado, United States
• Otsuka Investigational Site — New Haven, Connecticut, United States
• Otsuka Investigational Site — Washington D.C., District of Columbia, United States
• Otsuka Investigational Site — Coral Gables, Florida, United States
• Otsuka Investigational Site — Hudson, Florida, United States
• Otsuka Investigational Site — Jacksonville, Florida, United States
• Otsuka Investigational Site — Melbourne, Florida, United States
• Otsuka Investigational Site — Port Charlotte, Florida, United States
• Otsuka Investigational Site — Tampa, Florida, United States
• Otsuka Investigational Site — Atlanta, Georgia, United States
• Otsuka Investigational Site — Augusta, Georgia, United States
• Otsuka Investigational Site — Meridian, Idaho, United States
• Otsuka Investigational Site — Chicago, Illinois, United States
• Otsuka Investigational Site — Peoria, Illinois, United States
• Otsuka Investigational Site 1 — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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