| Trial ID: | L1049 |
| Source ID: | NCT01901107
|
| Associated Drug: |
Kiklin Capsules
|
| Title: |
Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis
|
| Interventions: |
DRUG: Kiklin capsules
|
| Outcome Measures: |
Primary: Safety assessed by the incidence of adverse events, physical exam and lab-tests, for one year | Secondary: Serum phosphate level, Baseline and 1, 2, 3, 6, 12 months after administration|Serum calcium level, Baseline and 1, 2, 3, 6, 12 months after administration|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: |
1078
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2013-01
|
| Completion Date: |
2016-12
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-27
|
| Locations: |
Chubu, Japan|Chugoku, Japan|Hokkaido, Japan|Kantou, Japan|Kinki, Japan|Kyusyu, Japan|Shikoku, Japan|Touhoku, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01901107
|
