| Trial ID: | L0911 |
| Source ID: | NCT01742585
|
| Associated Drug: |
Asp1585
|
| Title: |
A Phase 3 Study of ASP1585 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|DRUG: placebo
|
| Outcome Measures: |
Primary: Change from baseline in serum phosphorus level at the end of treatment, Baseline and Week 12 or treatment discontinuation | Secondary: Achievement rate of the target range of serum phosphorus level, During 12 week treatment|Time to achieve the target range of serum phosphorus level, During 12 week treatment|Time-course changes in serum phosphorus levels, During 12 week treatment|Time-course changes in serum calcium levels, During 12 week treatment|Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs, During 12 week treatment
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
163
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-10
|
| Completion Date: |
2014-05
|
| Results First Posted: |
|
| Last Update Posted: |
2014-07-16
|
| Locations: |
Chubu, Japan|Hokkaido, Japan|Kansai, Japan|Kanto, Japan|Kyushu, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01742585
|
