| Trial ID: | L0874 |
| Source ID: | NCT01742611
|
| Associated Drug: |
Asp1585
|
| Title: |
Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Renal Insufficiency|Hyperphosphatemia
|
| Interventions: |
DRUG: ASP1585
|
| Outcome Measures: |
Primary: Time-course changes in serum phosphorus levels, During 48 week treatment | Secondary: Achievement rate of the target range of serum phosphorus level, During 48 week treatment|Time to achieve the target range of serum phosphorus level, During 48 week treatment|Time-course changes in serum calcium levels, During 48 week treatment|Time-course changes in serum intact PTH (parathyroid hormone) levels, During 48 week treatment|Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs, During 48 week treatment
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
105
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-03
|
| Completion Date: |
2015-04
|
| Results First Posted: |
|
| Last Update Posted: |
2015-06-09
|
| Locations: |
Chubu, Japan|Hokkaido, Japan|Kansai, Japan|Kanto, Japan|Kyushu, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01742611
|
