NCT01348035

Efficacy Study of Water Drinking on PKD Progression.

Efficacy Study of Long-term Water Intake on the Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Kyorin University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD.

Detailed description

Tolvaptan was approved in Japan for the treatment of autosomal dominant polycystic kidney disease (ADPKD) in March 2014. This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD. Study results will be summarized, analyzed, and compiled into a research paper at 3 years (data cut-off, March 31, 2018) and at 5 years (data cut-off, March 31, 2020)

Conditions

• Autosomal Dominant Polycystic Kidney Disease
• Disease Progression

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-11-01
• Completion: 2013-01-01
• First posted: 2011-05-05
• Last updated: 2018-03-15

Locations

1 site across 1 country: Japan