Clinical Trial Details
| Trial ID: | L0152 |
| Source ID: | NCT02805348 |
| Associated Drug: | Bixalomer |
| Title: | Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease |
| Interventions: | DRUG: Bixalomer |
| Outcome Measures: | Primary: 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 | |
| Sponsor/Collaborators: | Sponsor: Astellas Pharma Inc |
| Gender: | ALL |
| Age: | CHILD, ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 144 |
| Study Type: | OBSERVATIONAL |
| Study Designs: | Observational Model: |Time Perspective: p |
| Start Date: | 2016-06-01 |
| Completion Date: | 2018-12-31 |
| Results First Posted: | |
| Last Update Posted: | 2024-10-16 |
| Locations: | Site JP00006, Aichi, Japan|Site JP00010, Ehime, Japan|Site JP00012, Fukuoka, Japan|Site JP00004, Gifu, Japan|Site JP00001, Ibaraki, Japan|Site JP00009, Kagawa, Japan|Site JP00003, Kanagawa, Japan|Site JP00011, Kochi, 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 |
| URL: | https://clinicaltrials.gov/show/NCT02805348 |
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