Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease
- Registration Number
- NCT02805348
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
Inclusion Criteria
- Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic kidney disease Bixalomer Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time.
- Primary Outcome Measures
Name Time Method Change from baseline in the serum concentrations of phosphate Baseline and up to Month 12 Change from baseline in the corrected serum concentrations of calcium Baseline and up to Month 12 Change from baseline in the serum concentrations of intact parathyroid hormone Baseline and up to Month 12 Safety assessed by incidence of adverse events Up to Month 12
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Site JP00004
🇯🇵Gifu, Japan
Site JP00001
🇯🇵Ibaraki, Japan
Site JP00003
🇯🇵Kanagawa, Japan
Site JP00014
🇯🇵Kumamoto, Japan
Site JP00013
🇯🇵Nagasaki, Japan
Site JP00007
🇯🇵Osaka, Japan
Site JP00005
🇯🇵Shizuoka, Japan
Site JP00002
🇯🇵Tochigi, Japan
Site JP00008
🇯🇵Wakayama, Japan
Site JP00006
🇯🇵Aichi, Japan
Site JP00010
🇯🇵Ehime, Japan
Site JP00012
🇯🇵Fukuoka, Japan
Site JP00009
🇯🇵Kagawa, Japan
Site JP00011
🇯🇵Kochi, Japan