NCT01430494

Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,409 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2011-09-08
• Last updated: 2015-04-23

Locations

266 sites across 20 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Italy, Japan, Netherlands, Norway, Poland, Romania, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom