The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
178
Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3
The primary endpoint was percent change from baseline in TKV at Week 3. Total kidney volume is an important measure of disease progression. A 3-week time point is adequate to assess acute effects on kidney cyst shrinkage.
Time frame: Baseline to Week 3
Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)
The ADPKD-UIS was a self-administered questionnaire designed to measure ADPKD-related urinary symptoms in participants with ADPKD. This instrument contained 11 items in 3 domains (Urinary Frequency, Urinary Urgency, and Nocturia). Each item was scored using a scale of 1 to 5 (a higher score indicated increased difficulty/extremely bothered). The maximum total score is 55; 1: not difficult/not bothered at all; 55: extremely difficult/extremely bothered.
Time frame: Baseline to Week 8
Percent Change From Baseline in TKV at Week 8.
Total kidney volume is an important measure of disease progression. A 3-week time point is adequate to assess acute effects on kidney cyst shrinkage.
Time frame: Baseline to Week 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Otsuka Investigational Site
Huntsville, Alabama, United States
Otsuka Investigational Site
Mobile, Alabama, United States
Otsuka Investigational Site
Peoria, Arizona, United States
Otsuka Investigational Site
Tempe, Arizona, United States
Otsuka Investigational Site
Los Angeles, California, United States
Otsuka Investigational Site
San Diego, California, United States
Otsuka Investigational Site 2
Aurora, 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
...and 25 more locations