Clinical Trial Details
| Trial ID: | L0094 |
| Source ID: | NCT01903213 |
| Associated Drug: | Bixalomer |
| Title: | Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Renal Failure |
| Interventions: | DRUG: bixalomer |
| Outcome Measures: | Primary: Safety assessed by the incidence of adverse events (including adverse drug reactions), vital signs and laboratory tests, Baseline and 1, 2, 3, 6, 12 months after administration | Secondary: Serum phosphorous levels, Baseline and 1, 2, 3, 6, 12 months after administration|Serum albumin level, Baseline and 1, 2, 3, 6, 12 months after administration|Serum calcium level, Baseline and 1, 2, 3, 6, 12 months after administration|Serum intact PTH (parathyroid hormone) level, Baseline and 1, 2, 3, 6, 12 months after administration |
| Sponsor/Collaborators: | Sponsor: Astellas Pharma Inc |
| Gender: | ALL |
| Age: | CHILD, ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 123 |
| Study Type: | OBSERVATIONAL |
| Study Designs: | Observational Model: |Time Perspective: p |
| Start Date: | 2013-03-19 |
| Completion Date: | 2019-12-31 |
| Results First Posted: | |
| Last Update Posted: | 2024-10-22 |
| Locations: | Chubu, Japan|Chugoku, Japan|Hokkaido, Japan|Kansai, Japan|Kanto, Japan|Kyushu, Japan|Shikoku, Japan|Tohoku, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01903213 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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